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

NCT01730573 | Completed

• 1 other identifier: 102994
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Disorder of Rotator Cuff

Keywords

interscalene; suprascapular; axillary

Outcome Measures

Primary Outcomes (1)

• Analgesic Efficacy

  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.

  one year

Secondary Outcomes (1)

• Side effects

  1 year

Other Outcomes (1)

• Patient satisfaction

  1 year

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.

Procedure: interscalene block

Suprascapular and Axillary nerve block

ACTIVE COMPARATOR

This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.

Procedure: Suprascapular and Axillary nerve block

Interventions

interscalene block PROCEDURE

This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.

Interscalene block

Suprascapular and Axillary nerve block PROCEDURE

This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.

Suprascapular and Axillary nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (2)

St. Joseph's Health Care

London, Ontario, N6A 4V5, Canada

Location

St. Joseph Hospital

London, Ontario, Canada

Location

Study Officials

• Shalini Dhir, MD, FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anaesthesia

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)