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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01730573
First received: November 9, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Disorder of Rotator Cuff
 Procedure: interscalene block
Procedure: Suprascapular and Axillary nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Analgesic Efficacy [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Side effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Patient satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interscalene block
This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
 Procedure: interscalene block
This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
Active Comparator: Suprascapular and Axillary nerve block
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
This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730573

Locations
Canada, Ontario
St. Joseph Hospital
London, Ontario, Canada
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shalini Dhir, MD, FRCPC University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Shalini Dhir, Associate Professor, Department of Anaesthesia, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01730573     History of Changes
Other Study ID Numbers: 102994
Study First Received: November 9, 2012
Last Updated: February 1, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
interscalene
suprascapular
axillary

ClinicalTrials.gov processed this record on May 21, 2013