Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

NCT02007057 | Completed Phase 4 DMC

• 1 other identifier: APR112013
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

Suprascapular nerve block; Interscalene nerve block

Outcome Measures

Primary Outcomes (1)

• Self-assessment of the mean shoulder pain

  Visual analog scale (VAS) during 2 days postoperatively

Secondary Outcomes (2)

• Self assessment of shoulder pain

  VAS twice daily during the first postoperative week

• Complications of locoregional anesthesia

  Yes or No during the first 24 hours

Study Arms (2)

Interscalene nerve block

ACTIVE COMPARATOR

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.

Procedure: Interscalene nerve block

Suprascapular nerve block

EXPERIMENTAL

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

Procedure: Suprascapular nerve block

Interventions

Suprascapular nerve block PROCEDURE

Suprascapular nerve block

Interscalene nerve block PROCEDURE

Interscalene nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead

Study Sites (1)

Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Hardy, MD, PhD

  Ambroise Pare Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Responsible of Clinical Research

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

FR (1)