Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

NCT ID: NCT02007057

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

Brief Summary

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.

Conditions

Rotator Cuff Tear; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Interscalene nerve block

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Suprascapular nerve block

Intervention Type: PROCEDURE

Interventions

Suprascapular nerve block

Intervention Type: PROCEDURE

Interscalene nerve block

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Ambroise Paré Paris

OTHER

Sponsor Role: lead

Responsible Party

Shahnaz Klouche, MD

Physician Responsible of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Hardy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ambroise Pare Hospital

Locations

Hopital Ambroise Pare

Boulogne-Billancourt, , France

Countries

France

Other Identifiers

APR112013

Identifier Type: -

Identifier Source: org_study_id