- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007057
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
Status
Completed
Conditions
Intervention / Treatment
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
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-
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Boulogne-Billancourt, France, 92100
- Hôpital Ambroise Paré
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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.
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|
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self assessment of shoulder pain
Time Frame: VAS twice daily during the first postoperative week
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VAS twice daily during the first postoperative week
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Complications of locoregional anesthesia
Time Frame: Yes or No during the first 24 hours
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Yes or No during the first 24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- APR112013
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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