- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977352
Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
March 2, 2018 updated by: St. Luke's-Roosevelt Hospital Center
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10025
- St. Luke's Roosevelt Hospital Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupivacaine 0.25%
20 cc of bupivacaine 0.25%
|
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Other Names:
|
Experimental: Liposomal bupivacaine
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
|
20 cc of bupivacaine 0.25%
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Opioid Consumption
Time Frame: 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.
|
Post op Day 1, post op Day 2, post op day 3, post op 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Analgesia
Time Frame: 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.
|
Post op Day 1, post op Day 2, post op day 3, post op 1 week
|
Sensory and Motor Block
Time Frame: 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.
|
at 20 min and at 1 hour
|
Time to First Pain Medicine
Time Frame: 72 hours
|
72 hours
|
|
Time to Discharge Home
Time Frame: 72 hours
|
data not collected
|
72 hours
|
Incidence of Postoperative Nausea and Vomiting
Time Frame: 72 hours
|
72 hours
|
|
Sleep Quality
Time Frame: 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
|
Post op Day 1, post op Day 2, post op day 3, post op 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ali Shariat, MD, St. Luke's-Roosevelt Hospital Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
October 30, 2013
First Posted (Estimate)
November 6, 2013
Study Record Updates
Last Update Posted (Actual)
April 2, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Arthralgia
- Rotator Cuff Injuries
- Shoulder Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- 13-0064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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