Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

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

Detailed Description
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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.

Official Title
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Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery

Conditions
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Injury of Shoulder Region

Intervention / Treatment
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* Drug: Exparel block in arthroscopic shoulder surgery
* Drug: Bupivacaine block in shoulder surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel block in arthroscopic surgery<br>Evaluation of Exparel block in arthroscopic shoulder surgery. | Drug: Exparel block in arthroscopic shoulder surgery<br>* The interscalene block will be performed with ultrasound guidance and nerve stimulation.<br>* Other names: ISBPB with bupivacaine and Exparel;|
| Experimental: Bupivacaine block in shoulder surgery<br>Evaluation of Bupivacaine block in shoulder surgery. | Drug: Bupivacaine block in shoulder surgery<br>* The interscalene block will be performed with ultrasound guidance and nerve stimulation.<br>* Other names: ISBPB with bupivacaine alone;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| duration of motor block |  | duration will be measured up to 72 hours | 
| functionality of the surgical arm |  | assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7 |