Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair

Not Applicable

Completed

• Conditions: Disorder of Rotator Cuff
• Interventions: Procedure: interscalene block; Procedure: Suprascapular and Axillary nerve block

• Registration Number: NCT01730573
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Primary objective of this study is to prospectively compare and evaluate efficacy as well as note side effects of the interscalene block and combined suprascapular and axillary nerve block for ambulatory arthroscopic rotator cuff repair.

Detailed Description

Patients having elective arthroscopic rotator cuff repair will be randomized to one of the two groups.

Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.

Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.

Performance time, quality and efficacy as well as any side-effects of the blocks will be evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning, opioid usage and patient satisfaction.

Primary hypothesis:

• Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as compared to interscalene block for arthroscopic rotator cuff repair.

Secondary hypothesis

• Interscalene block is associated with more side effects and complications as compared to suprascapular nerve block and axillary nerve block.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-21
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-11
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Elective shoulder arthroscopic rotator cuff repair
• ASA I - III (American Society of Anaesthesia Classification)

Exclusion Criteria

• ASA IV or higher ( American Society of Anaesthesia Classification)
• Obesity: BMI >35
• Narcotic Abuse/ Drug dependency
• Major Neurologic deficits
• Allergy to local anesthetics
• Infection in the site of the puncture
• Mental impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interscalene block	interscalene block	This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
Suprascapular and Axillary nerve block	Suprascapular and Axillary nerve block	This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.

Primary Outcome Measures

Name	Time	Method
Analgesic Efficacy	one year	Visual Analogue scores for pain will be analyzed using chi-squared test. Interscalene block (ISB) of the brachial plexus has been demonstrated to be one of the most effective analgesic modality during arthroscopic shoulder surgery. However, despite its (ISB) time-tested record of relative safety, ISB is associated with some complications. These could be central nervous system, respiratory and cardiovascular complications. These side effects and complications are based upon the anatomy of the brachial plexus at this level.Recently, suprascapular and axillary nerve blocks have been used to control postoperative shoulder pain. The study will try to find out whether combined supra scapular and axillary nerve blocks are as effective in pain control as compared to inter scalene block.

Secondary Outcome Measures

Name	Time	Method
Side effects	1 year	The study will try to find out whether combined supra scapular and axillary nerve blocks are associated with less side effects as compared to inter scalene block.

Trial Locations

Locations (2)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada

St. Joseph Hospital; 🇨🇦 London, Ontario, Canada