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Completed

NCT Number: NCT01730573

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

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.

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Key information

Conditions

Disorder of Rotator Cuff

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph Hospital, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interscalene block

Procedure

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

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.

Primary outcomes

  1. Analgesic Efficacy

    Time frame: 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 outcomes

  1. Side effects

    Time frame: 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.

Other outcomes

  1. Patient satisfaction

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2012
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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