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Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

Primary Purpose

Rotator Cuff Tear, Pain

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Suprascapular nerve block
Interscalene nerve block
Sponsored by
Hospital Ambroise Paré Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Suprascapular nerve block, Interscalene nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Ambroise Pare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Interscalene nerve block

Suprascapular nerve block

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Self-assessment of the mean shoulder pain

Secondary Outcome Measures

Self assessment of shoulder pain
Complications of locoregional anesthesia

Full Information

First Posted
November 29, 2013
Last Updated
February 6, 2015
Sponsor
Hospital Ambroise Paré Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02007057
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Ambroise Paré Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Pain
Keywords
Suprascapular nerve block, Interscalene nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene nerve block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Suprascapular nerve block
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Suprascapular nerve block
Intervention Type
Procedure
Intervention Name(s)
Interscalene nerve block
Primary Outcome Measure Information:
Title
Self-assessment of the mean shoulder pain
Time Frame
Visual analog scale (VAS) during 2 days postoperatively
Secondary Outcome Measure Information:
Title
Self assessment of shoulder pain
Time Frame
VAS twice daily during the first postoperative week
Title
Complications of locoregional anesthesia
Time Frame
Yes or No during the first 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Hardy, MD, PhD
Organizational Affiliation
Ambroise Pare Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Ambroise Pare
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France

12. IPD Sharing Statement

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Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

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