Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007057
• Other study ID #: APR112013
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2013
• Last updated: February 6, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Drug National Security Agency (ANSM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Rotator Cuff Tear

Intervention

Procedure:
• Suprascapular nerve block

• Interscalene nerve block

Locations

Country	Name	City	State
France	Hopital Ambroise Pare	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-assessment of the mean shoulder pain		Visual analog scale (VAS) during 2 days postoperatively	No
Secondary	Self assessment of shoulder pain		VAS twice daily during the first postoperative week	No
Secondary	Complications of locoregional anesthesia		Yes or No during the first 24 hours	Yes