Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01977352
Recruitment Status : Completed
First Posted : November 6, 2013
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Rotator Cuff Tear Drug: Liposomal bupivacaine Drug: Bupivacaine 0.25% Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Bupivacaine 0.25%
20 cc of bupivacaine 0.25%
 Drug: Liposomal bupivacaine
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Other Name: Exparel
Experimental: Liposomal bupivacaine
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
 Drug: Bupivacaine 0.25%
20 cc of bupivacaine 0.25%
Other Name: Bupivacaine


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Time to First Pain Medicine [ Time Frame: 72 hours ]
  4. Time to Discharge Home [ Time Frame: 72 hours ]
    data not collected

  5. Incidence of Postoperative Nausea and Vomiting [ Time Frame: 72 hours ]
  6. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977352


Locations
Layout table for location information
United States, New York
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Layout table for investigator information
Principal Investigator: Ali Shariat, MD St. Luke's-Roosevelt Hospital Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01977352    
Other Study ID Numbers: 13-0064
First Posted: November 6, 2013    Key Record Dates
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018
Last Verified: March 2018
Keywords provided by St. Luke's-Roosevelt Hospital Center:
Exparel
Liposomal Bupivacaine
Arthroscopic Shoulder Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Rotator Cuff Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Rupture
Wounds and Injuries
 Shoulder Injuries
Tendon Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents