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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

November 9, 2012
February 1, 2013
November 2012
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01730573 on ClinicalTrials.gov Archive Site
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.
Same as current
Patient satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
 
Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair
A Randomized Comparison of Inter Scalene and Combined Supra Scapular and Axillary Nerve Blocks for Postoperative Pain Relief in Arthroscopic Shoulder 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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Disorder of Rotator Cuff
  • Procedure: interscalene block
    This arm patients will receive inter scalene block which will be ultrasound 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.
  • Active Comparator: Interscalene block
    This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
    Intervention: Procedure: interscalene block
  • 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.
    Intervention: Procedure: Suprascapular and Axillary nerve block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01730573
102994
No
Shalini Dhir, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Shalini Dhir, MD, FRCPC University of Western Ontario, Canada
Lawson Health Research Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP