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

Shoulder Pain Clinical Trial

Official title:

Comparison of Cumulative Opioid Consumption After Interscalene Brachial Plexus Block With Liposomal Bupivacaine (Exparel; 88 mg in 20 cc) Versus Bupivacaine 0.25% for Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977352
• Other study ID #: 13-0064
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2013
• Last updated: March 2, 2018
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2018
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Pain

Intervention

Drug:
• Liposomal bupivacaine
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
• Bupivacaine 0.25%
20 cc of bupivacaine 0.25%

Locations

Country	Name	City	State
United States	St. Luke's Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post op Day 1, post op Day 2, post op day 3, post op 1 week
Secondary	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.	Post op Day 1, post op Day 2, post op day 3, post op 1 week
Secondary	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.	at 20 min and at 1 hour
Secondary	Time to First Pain Medicine		72 hours
Secondary	Time to Discharge Home	data not collected	72 hours
Secondary	Incidence of Postoperative Nausea and Vomiting		72 hours
Secondary	Sleep Quality	scale of 0-10, 0=horrible, up all night; 10=perfect sleep	Post op Day 1, post op Day 2, post op day 3, post op 1 week