Back to resultsEfficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Primary Purpose
Shoulder Pain, Rotator Cuff Tear
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine 0.25%
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Exparel, Liposomal Bupivacaine, Arthroscopic Shoulder Surgery
Eligibility Criteria
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.
Sites / Locations
- St. Luke's Roosevelt Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bupivacaine 0.25%
Liposomal bupivacaine
Arm Description
20 cc of bupivacaine 0.25%
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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 to First Pain Medicine
Time to Discharge Home
data not collected
Incidence of Postoperative Nausea and Vomiting
Sleep Quality
scale of 0-10, 0=horrible, up all night; 10=perfect sleep
Full Information
NCT ID
NCT01977352
First Posted
October 30, 2013
Last Updated
March 2, 2018
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT01977352
Brief Title
Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Rotator Cuff Tear
Keywords
Exparel, Liposomal Bupivacaine, Arthroscopic Shoulder Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine 0.25%
Arm Type
Active Comparator
Arm Description
20 cc of bupivacaine 0.25%
Arm Title
Liposomal bupivacaine
Arm Type
Experimental
Arm Description
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25%
Other Intervention Name(s)
Bupivacaine
Intervention Description
20 cc of bupivacaine 0.25%
Primary Outcome Measure Information:
Title
Total Opioid Consumption
Description
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 Outcome Measure Information:
Title
Quality of Analgesia
Description
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
Title
Sensory and Motor Block
Description
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
Title
Time to First Pain Medicine
Time Frame
72 hours
Title
Time to Discharge Home
Description
data not collected
Time Frame
72 hours
Title
Incidence of Postoperative Nausea and Vomiting
Time Frame
72 hours
Title
Sleep Quality
Description
scale of 0-10, 0=horrible, up all night; 10=perfect sleep
Time Frame
Post op Day 1, post op Day 2, post op day 3, post op 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Shariat, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
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