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Clinical Trials/NCT02007057
NCT02007057CompletedPhase 4

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

Hospital Ambroise Paré Paris2 sites in 1 country74 target enrollmentStarted: November 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
74
Locations
2
Primary Endpoint
Self-assessment of the mean shoulder pain

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Self-assessment of the mean shoulder pain

Time Frame: Visual analog scale (VAS) during 2 days postoperatively

Secondary Outcomes

  • 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)

Investigators

Sponsor
Hospital Ambroise Paré Paris
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shahnaz Klouche, MD

Physician Responsible of Clinical Research

Hospital Ambroise Paré Paris

Study Sites (2)

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