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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

Clinicaltrials.gov identifier NCT03940469

Recruitment Status Completed

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

Brief summary:

The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

  • Condition or Disease:Postoperative Analgesia
    Postoperative Complications
  • Intervention/Treatment: Drug: Saline
    Drug: Dexamethasone Injection
    Drug: Dexmedetomidine Hydrochloride
  • Phase: Phase 4
Detailed Description

Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
  • Actual Study Start Date: July 2016
  • Actual Primary Completion Date: January 2019
  • Actual Study Completion Date: January 2019
Arms and interventions
Arm Intervention/treatment
Placebo Comparator: Control group
received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
Drug: Saline
2 ml normal saline
Active Comparator: Dexamethasone group
received 35ml levobupivacaine+8mg dexamethasone
Drug: Dexamethasone Injection
8 mg dexamethasone
Active Comparator: Dexmeteomidine group
received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
Drug: Dexmedetomidine Hydrochloride
100 microgram dexmedetomidine
Outcome Measures
  • Primary Outcome Measures: 1. Changes in postoperative analgesia [ Time Frame: During first 2 days after surgery ]
    Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).
  • Secondary Outcome Measures: 1. Postoperative analgesic requirement [ Time Frame: During first 2 days after surgery ]
    Total amount of paracetamol required in mg
  • 2. Hemodynamic parameter [ Time Frame: During first 2 days after surgery ]
    Heart rate
  • 3. Hemodynamic parameter [ Time Frame: During first 2 days after surgery ]
    Mean arterial blood pressure
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Sixty healthy patients ASA I-II

- Aged 18-60 years

- Of both sexes

- Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.

Exclusion Criteria:

- Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or
α2 agonists

- All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, -
Patients who were under treatment by α2 agonist or antagonists

- Pregnant women

- Psychiatric patients

- Patients with a previous history or clinical evidence of central or peripheral
neurological disease

- Coagulopathy or anticoagulant/antiaggregant therapy

- Contralateral phrenic nerve paresis

- Patients who have an infection at the site of the block.

- Every patient who had an anatomical or vascular abnormality in the upper extremity
were excluded from this study.

Contacts and Locations
Contacts
Locations

Egypt, Menoufiya
Ashraf Eskandr
Shibīn Al Kawm

Sponsors and Collaborators

Menoufia University

Mamdoh Elsayed Lotfy

Osama Abdallah Elsharkawy

Basma Abdelhamid Fathy

Investigators

Study Director: mamdouh e lotfy, m.d. emeritus professor

More Information
  • Responsible Party: Menoufia University
  • ClinicalTrials.gov Identifier: NCT03940469 History of Changes
  • Other Study ID Numbers: Interscalene Dexmedetomidine
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Menoufia University: Dexmedetomidine
    Dexamethasone
    Interscalene
  • Additional relevant MeSH terms: Postoperative Complications