Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

Not Applicable

Completed

• Conditions: Injury of Shoulder Region
• Interventions: Drug: Bupivacaine block in shoulder surgery; Drug: Exparel block in arthroscopic shoulder surgery

• Registration Number: NCT02554357
• Lead Sponsor: North American Institute for Continuing Medical Education (NAICE)

Brief Summary

Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.

Detailed Description

The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.

Moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-11
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-18
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Dutch or English speaking adults
• 18 years or older ASA I-III physical class
• Scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria

• History of allergy to a local anesthetic
• Baseline neurological deficit
• Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
• Recent history (< 3 months) of drug or alcohol abuse
• Concomitant opioid therapy
• Preexisting coagulation disorder
• Infection at the injection site
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine block in shoulder surgery	Bupivacaine block in shoulder surgery	Evaluation of Bupivacaine block in shoulder surgery.
Exparel block in arthroscopic surgery	Exparel block in arthroscopic shoulder surgery	Evaluation of Exparel block in arthroscopic shoulder surgery.

Primary Outcome Measures

Name	Time	Method
Satisfaction with analgesia	assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7
Worst pain	assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7

Secondary Outcome Measures

Name	Time	Method
functionality of the surgical arm	assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7
duration of motor block	duration will be measured up to 72 hours
Onset of sensory block	onset will be measured up to 30 minutes
Duration of sensory block	duration will be measured up to 72 hours
Onset of motor block	onset will be measured up to 30 minutes

Trial Locations

Locations (2)

Department of Anesthesiology Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Department of Anesthesiology ZOL; 🇧🇪 Genk, Belgium