Clinical trial NCT02007057: Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery
Official title: Prospective Randomized Comparative Study of the Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotator Cuff Tear
Pain
Keywords: Suprascapular nerve block
Interscalene nerve block
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Self-assessment of the mean shoulder pain
timeFrame: Visual analog scale (VAS) during 2 days postoperatively
Secondary outcomes:
measure: Self assessment of shoulder pain
timeFrame: VAS twice daily during the first postoperative week
measure: Complications of locoregional anesthesia
timeFrame: Yes or No during the first 24 hours
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hopital Ambroise Pare
Study officials:
affiliation: Ambroise Pare Hospital
name: Philippe Hardy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: