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

Phase 4CompletedNCT01977352

St. Luke's-Roosevelt Hospital Center42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Shoulder Pain Rotator Cuff Tear

Interventions

Liposomal bupivacaineDRUG

liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Bupivacaine 0.25%DRUG

20 cc of bupivacaine 0.25%

Eligibility

Sex: ALLMin age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Locations (1)

St. Luke's Roosevelt Hospital Center

New York, New York, United States

Outcomes

Primary Outcomes

Total Opioid Consumption

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.

Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week

Secondary Outcomes

Quality of Analgesia

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.

Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week

Sensory and Motor Block

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 frame: at 20 min and at 1 hour

Time to First Pain Medicine

Time frame: 72 hours

Time to Discharge Home

data not collected

Time frame: 72 hours

Incidence of Postoperative Nausea and Vomiting

Time frame: 72 hours

Sleep Quality

scale of 0-10, 0=horrible, up all night; 10=perfect sleep

Data from ClinicalTrials.gov

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