Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

February 6, 2015 updated by: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

Prospective Randomized Comparative Study of the Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic surgery but does not provide a satisfactory postoperative analgesia . The locoregional anesthesia is recommended and includes several techniques: the interscalene nerve block, the suprascapular nerve block, intra-articular injection of local anesthetic and subacromial infiltration. The interscalene nerve block is currently the gold standard for anesthesia and postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% . However it must be carried out by teams experienced in the locoregional anesthesia because it is operator -dependent. The suprascapular nerve block is a simple technique that can be performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less invasive than the interscalene nerve block and exposing the patient to fewer complications. However, his interest was not assessed in the repair of tendons of the rotator cuff. The main hypothesis of this study is that the suprascapular nerve block is as effective as the interscalene nerve block in the prevention of early postoperative pain after arthroscopic repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the analgesic consumption while reducing the risk of complications related to regional anesthesia.

Study Overview

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Boulogne-Billancourt, France, 92100
        • Hôpital Ambroise Paré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged over 18 years
  • Arthroscopic repair of infra and / or supraspinatus tendon of the rotator cuff with or without associated procedure on the biceps, the acromion-clavicular joint or acromion
  • Informed consent

Exclusion Criteria:

  • Allergy to local anesthetics (ropivacaine, bupivacaine, xylocaine)
  • Previous surgery on the involved shoulder
  • Severe or morbid obesity (BMI> 35)
  • Psychiatric disorders (impossible self-assessment of the pain)
  • Patient unfit physically, mentally or legally to give informed consent
  • Patient refusal
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interscalene nerve block
Interscalene block is performed preoperatively with ultrasound guidance and neurostimulation 0.8 milliampere. The block is performed using "in-plane" approach with a needle of 50 mm for a neurostimulation. During the injection, it is verified that the diffusion extends to the anterior and posterior space. If the posterior distribution is limited, the needle is remobilized to obtain an overall diffusion: a bolus of 20 mL of ropivacaine 0.75% is made by the anesthetist. The effectiveness of the nerve block is checked before the start of surgery.
Experimental: Suprascapular nerve block
The suprascapular block is performed at the end of surgery when the incisions are closed but before the removal of the surgical drapes. The material used is a compound of a 10 cc syringe sterile equipment, a green intramuscular needle (14 gauge) and a bulb 10 cc of 0.75% Ropivacaine. The injection of 10 cc is realized by the technical princeps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-assessment of the mean shoulder pain
Time Frame: Visual analog scale (VAS) during 2 days postoperatively
Visual analog scale (VAS) during 2 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Self assessment of shoulder pain
Time Frame: VAS twice daily during the first postoperative week
VAS twice daily during the first postoperative week
Complications of locoregional anesthesia
Time Frame: Yes or No during the first 24 hours
Yes or No during the first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philippe Hardy, MD, PhD, Ambroise Paré Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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