Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

Phase 4

Completed

• Conditions: Shoulder Pain; Rotator Cuff Tear
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivacaine 0.25%

• Registration Number: NCT01977352
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Study Start: 2014-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2017-05-10
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-02
• Last Update Submitted: 2018-03-02
• Results First Posted: 2018-04-02
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.

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Exclusion Criteria

• Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine 0.25%	Liposomal bupivacaine	20 cc of bupivacaine 0.25%
Liposomal bupivacaine	Bupivacaine 0.25%	liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption	Post op Day 1, post op Day 2, post op day 3, post op 1 week	Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.

Secondary Outcome Measures

Name	Time	Method
Time to Discharge Home	72 hours	data not collected
Quality of Analgesia	Post op Day 1, post op Day 2, post op day 3, post op 1 week	The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain.
Sensory and Motor Block	at 20 min and at 1 hour	Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function.
Time to First Pain Medicine	72 hours
Incidence of Postoperative Nausea and Vomiting	72 hours
Sleep Quality	Post op Day 1, post op Day 2, post op day 3, post op 1 week	scale of 0-10, 0=horrible, up all night; 10=perfect sleep

Trial Locations

Locations (1)

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States