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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures

Clinicaltrials.gov identifier NCT03919916

Recruitment Status Not yet recruiting

First Posted April 18, 2019

Last update posted February 5, 2020

Study Description

Brief summary:

In this multicentre randomised controlled trial, adult patients with isolated chest trauma and two or more unilateral rib fractures will be randomised to either serratus plane block and patient controlled analgesia or patient controlled analgesia alone. Our primary outcome is the static visual analogue scale score at one hour.

  • Condition or Disease:Rib Fractures
    Levobupivacaine
    Thoracic Injuries
    Analgesia, Patient-Controlled
    Pain
    Anaesthesia, Local
  • Intervention/Treatment: Procedure: Serratus plane block
    Drug: Patient controlled analgesia
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 58 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
  • Estimated Study Start Date: February 2020
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: July 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Serratus plane block and patient controlled analgesia
Initial local anaesthetic bolus of 0.4 ml/kg of 0.25% levobupivacaine. Subsequent continuous local anaesthetic infusion of 0.125% levobupivacaine Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes
Procedure: Serratus plane block
Placement of initial local anaesthetic bolus and catheter for continuous infusion in the plane between latissimus dorsi and serratus anterior in the midaxillary line at the level of the 5th rib

Drug: Patient controlled analgesia
Computerised pump device facilitating the patient self administration and titration as needed of morphine
Active Comparator: Patient controlled analgesia only
Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes
Drug: Patient controlled analgesia
Computerised pump device facilitating the patient self administration and titration as needed of morphine
Outcome Measures
  • Primary Outcome Measures: 1. Static visual analogue score (0-10) at 1 hour [ Time Frame: Measured at 1 hour ]
    Defined as pain score at rest
  • Secondary Outcome Measures: 1. Dynamic visual analogue score (0-10) [ Time Frame: Measured at 1 hour, 24, 48 and 72 hours ]
    Defined as pain score on deep inspiration
  • 2. Static visual analogue score (0-10) [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as pain score at rest
  • 3. Morphine consumption [ Time Frame: Measured at 24, 48 and 72 hours ]
    Amount of intravenous morphine consumed within each 24 hour period
  • 4. Peak expiratory flow rate [ Time Frame: Measured at 1, 24, 48 and 72 hours ]
    Calculated as a percentage of predicted
  • 5. Level of sedation [ Time Frame: Measured at 24, 48 and 72 hours ]
    Assessed using the Ramsay Sedation Scale (1-6) and a value of 2 is considered the best outcome
  • 6. Incidence of hypotension [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a systolic blood pressure less than 90 mmHg
  • 7. Incidence of nausea and vomiting [ Time Frame: Measured at 24, 48 and 72 hours ]
    Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome
  • 8. Incidence of respiratory depression [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a respiratory rate of less than 12 breaths per minute
  • 9. Occurrence of pneumonia [ Time Frame: Within 30 days ]
  • 10. Hospital length of stay [ Time Frame: Up to 6 months ]
    Defined as the number of days the patient stayed in hospital
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 18 years of age or older

- Isolated chest trauma

- Two or more unilateral rib fractures

Exclusion Criteria:

- Bilateral rib fractures

- Clavicular fractures

- Polytrauma

- Sternal fracture or injury

- Thoracic spine injury

- Decreased Glasgow Coma Scale score

- Dementia

- Delirium or psychiatric illness

- Chronic lung disease

- Coagulopathy

- End stage liver disease

- Significant renal failure, defined as a creatinine >150µmol/l

- Local infection at potential site of SBP insertion

- Pregnancy or breastfeeding

- History of chronic pain or opioid dependence

- Current chronic analgesic therapy

- Requirement for tracheal intubation and mechanical ventilation

- Allergy to local anaesthetics and/or opioids

- Inability to control and self-administer opioids with PCA due to confusion, learning
difficulties or poor manual dexterity

- Unable to speak and/or understand English

Contacts and Locations
Contacts

Contact: Robert J Pilling, MB ChB FRCA 02033158000 ext 58026 Robert.Pilling@chelwest.nhs.uk

Contact: Neel Desai, MB ChB FRCA 02033158000 ext 58026 Neel.Desai@gstt.nhs.uk

Locations
Sponsors and Collaborators

Chelsea and Westminster NHS Foundation Trust

St George's University Hospitals NHS Foundation Trust

Investigators

Study Chair: Damon Foster Sponsor Representative, Research Delivery Operations Manager, Chelsea and Westminster Hospital NHS Foundation Trust

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