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

Disorder of Rotator Cuff Clinical Trial

Official title:

A Randomized Comparison of Inter Scalene and Combined Supra Scapular and Axillary Nerve Blocks for Postoperative Pain Relief in Arthroscopic Shoulder Rotator Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730573
• Other study ID #: 102994
• Status: Completed
• Phase: N/A
• First received: November 9, 2012
• Last updated: February 11, 2017
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorder of Rotator Cuff

Intervention

Procedure:
• interscalene block
This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
• Suprascapular and Axillary nerve block
This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.

Locations

Country	Name	City	State
Canada	St. Joseph Hospital	London	Ontario
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction		1 year
Primary	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	Side effects	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.	1 year