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Paravertebral Block for Proximal Humeral Fracture Surgery

  • Clinicaltrials.gov identifier

    NCT03919422

  • Recruitment Status

    Completed

  • First Posted

    April 18, 2019

  • Result First Posted

    January 5, 2021

  • Last update posted

    January 5, 2021

Study Description

Brief summary:

This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half.

  • Condition or Disease:Proximal Humeral Fracture
  • Intervention/Treatment: Procedure: T2 paravertebral block
    Procedure: interscalene brachial plexus block and superficial cervical plexus block
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 80 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Effectiveness of Additional Thoracic Paravertebral Block in Improving Anesthetic Effects of Regional Anesthesia for Proximal Humeral Fracture Surgery in Elderly Patients: Study Protocol for a Randomized Controlled Trial
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: August 2020
  • Actual Study Completion Date: August 2020

Arms and interventions

Arm Intervention/treatment
Experimental: ICTP group
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
Procedure: T2 paravertebral block
Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).

Procedure: interscalene brachial plexus block and superficial cervical plexus block
An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
Active Comparator: IC group
Interscalene brachial plexus-Cervical plexus
Procedure: interscalene brachial plexus block and superficial cervical plexus block
An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.

Outcome Measures

  • Primary Outcome Measures: 1. Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon.
  • Secondary Outcome Measures: 1. Assessment of Sensory Blockade [ Time Frame: 20 minutes after all the nerve block operations have been finished ]
    Sensory blockade graded from 0 to 2(0= normal sensation, 1= decreased sensation and 2= no perception) by applying pinprick and cold test to the different parts of shoulder
  • 2. Proportion of Participants Completed the Procedure With Remifentanil [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    When the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, the procedure will continue if the participant can tolerate the pain.
  • 3. Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    When the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, if the participant cannot tolerate the pain, a general anesthesia with LMA will be given.
  • 4. Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) [ Time Frame: At the end of surgical procedure(an average of 2 to 3 hours) ]
    Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.
  • 5. Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) [ Time Frame: At the end of surgical procedure(an average of 2 to 3 hours) ]
    Cumulative doses of intravenous deoxyepinephrine required during the surgery.
  • 6. Complications Related With Anesthesia [ Time Frame: within 24 hours since the nerve block finished ]
    Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma
  • 7. Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.

Eligibility Criteria

  • Ages Eligible for Study: 65 Years and older (Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Participant age≥ 65 years

2. Body mass index (BMI) < 30kg/m2 3. American Society of Anesthesiologists (ASA) classification I-II 4. Anterior operative incision approach Exclusion Criteria: 1. Request for general anesthesia 2. Nerve block is unable to be performed due to various reasons 3. Coagulation dysfunction or anticoagulation therapy 4. History of upper limb nerve injury or phrenic nerve injury 5. Multiple trauma 6. Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.) 7. Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg) 8. Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.) 9. Stroke or cognitive dysfunction (unable to communicate or cooperate) 10. Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)

Contacts and Locations

Contacts

Locations

China, Shanghai
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai

Sponsors and Collaborators

Shanghai 6th People's Hospital

More Information

  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Single;Primary Purpose: Treatment
  • Condition: Proximal Humeral Fracture
  • Interventions : Procedure: T2 paravertebral block
    Procedure: interscalene brachial plexus block and superficial cervical plexus block
  • Enrollment: 80

Participant flow

  • Recruitment Details 121participants were screened. 41 did not meet criteria.
  • Pre-assignment Details

  • Arm/Group title ICTP Group IC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus. Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
    Period Title: Overall Study
  • Started 40 40
  • Completed 40 40
  • Not Completed 0 0
  • Reason Not Completed
Baseline Characteristics
  • Arm/Group title TotalICTP GroupIC Group
  • Arm/Group Description Total of all reporting groupsInterscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Baseline Participants 804040
  • Baseline Analysis Population Description [Not Specified]
Outcome Measures

1. PrimaryOutcome

  • Title Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
  • Description Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon.
  • Time Frame throughout the operation duration, an average of 2 to 3 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 21
    31

2. SecondaryOutcome

  • Title Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
  • Description Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.
  • Time Frame throughout the operation duration, an average of 2 to 3 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • Number of participants with dyspnea during the surgery 2
    5
  • Number of participants with tachycardia druing the surgery 1

  • Number of participants with bradycardia during the surgery 8
    5
  • Number of participants with hypotension during the surgery 5
    4
  • Number of participants with hypertension during the surgery 7
    6

3. SecondaryOutcome

  • Title Complications Related With Anesthesia
  • Description Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma
  • Time Frame within 24 hours since the nerve block finished
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • total spinal block

  • hematoma

  • epidural block

  • pneumothorax

  • local anesthetic systemic toxicity

4. SecondaryOutcome

  • Title Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
  • Description Cumulative doses of intravenous deoxyepinephrine required during the surgery.
  • Time Frame At the end of surgical procedure(an average of 2 to 3 hours)
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: ug
  • 7.5
    5.0

5. SecondaryOutcome

  • Title Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
  • Description Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.
  • Time Frame At the end of surgical procedure(an average of 2 to 3 hours)
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: mg
  • ephedrine (mg) 0.5
    1.00
  • atropine (mg) 0.09
    0.05
  • urapidil (mg) 1.50
    1.13

6. SecondaryOutcome

  • Title Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)
  • Description When the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, if the participant cannot tolerate the pain, a general anesthesia with LMA will be given.
  • Time Frame throughout the operation duration, an average of 2 to 3 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 2
    6

7. SecondaryOutcome

  • Title Proportion of Participants Completed the Procedure With Remifentanil
  • Description When the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, the procedure will continue if the participant can tolerate the pain.
  • Time Frame throughout the operation duration, an average of 2 to 3 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 7
    13

8. SecondaryOutcome

  • Title Assessment of Sensory Blockade
  • Description Sensory blockade graded from 0 to 2(0= normal sensation, 1= decreased sensation and 2= no perception) by applying pinprick and cold test to the different parts of shoulder
  • Time Frame 20 minutes after all the nerve block operations have been finished
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
  • Overall Number of Participants Analyzed 4040
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • medial part of upper arm 17

  • medial part of upper arm 17
    4
  • medial part of upper arm 6
    36
  • lateral part of upper arm 37
    36
  • lateral part of upper arm 3
    4
  • lateral part of upper arm

  • deltoid area 38
    37
  • deltoid area 2
    3
  • deltoid area

  • distal clavicle area 39
    37
  • distal clavicle area 1
    2
  • distal clavicle area
    1
Adverse Events
  • Time Frame 1day after surgery
  • Adverse Event Reporting Description Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
  •  
  • Arm/Group Title ICTP GroupIC Group
  • Arm/Group Description Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.

All-Cause Mortality

  • IC Group ICTP Group
  • Affected at Risk (%) Affected at Risk (%)
  • Total 0/40 (0.00%) 0/40 (0.00%)
  • Total
  • Total, all-cause mortality 0 /40 (0.00%) 0 /40 (0.00%)

Serious Adverse Events

  • IC Group ICTP Group
  • Affected at Risk (%) Affected at Risk (%)
  • Total 0/40 (0.00%) 0/40 (0.00%)
  • Nervous system disorders
  • total spinal block 0 /40 (0.00%) 0 /40 (0.00%)
  • epidural block 0 /40 (0.00%) 0 /40 (0.00%)
  • local anesthetic systemic toxicity 0 /40 (0.00%) 0 /40 (0.00%)
  • Respiratory, thoracic and mediastinal disorders
  • pneumothorax 0 /40 (0.00%) 0 /40 (0.00%)
  • Total
  • Total, serious adverse events 0 /40 (0.00%) 0 /40 (0.00%)
  • Vascular disorders
  • hematoma 0 /40 (0.00%) 0 /40 (0.00%)

Show Other (Not Including Serious) Adverse Events

  • IC Group ICTP Group
  • Affected / at Risk (%) Events Affected / at Risk (%) Events
  • Total 20/40 (50.00%) 23/40 (57.50%)
  • Cardiac disorders
  • tachycardia 0 /40 (0.00%) 0 1 /40 (2.50%) 1
  • bradycardia 5 /40 (12.50%) 5 8 /40 (20.00%) 8
  • hypotension 4 /40 (10.00%) 4 5 /40 (12.50%) 5
  • Hypertension 6 /40 (15.00%) 6 7 /40 (17.50%) 7
  • Respiratory, thoracic and mediastinal disorders
  • dyspnea 5 /40 (12.50%) 5 2 /40 (5.00%) 2
  • Total
  • Total, other adverse events 20 /40 (50.00%) 0 23 /40 (57.50%) 0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

  • Name/Title:Dr. Junfen Zhang, director of the clinical trial
  • Organization:Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Phone:+8618930173689
  • EMail:zhangjunfeng@sjtu.edu.cn
  • ClinicalTrials.gov Identifier: NCT03919422 History of Changes
  • Other Study ID Numbers: 2019-030
  • First Submitted: April 14, 2019
  • First Posted: April 18, 2019
  • Results First Submitted: November 6, 2020
  • Results First Posted: January 5, 2021
  • Last Update Posted: January 5, 2021