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Trial record 18 of 42 for:    Heart Block | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT02762071
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Southern Maryland Orthopaedic & Sports Medicine Center
William Beaumont Army Medical Center
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthropathy Shoulder Pain Closed Fracture Proximal Humerus, Four Part Drug: Liposomal bupivacaine Drug: Interscalene Nerve Block Not Applicable

Detailed Description:

After the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial.

Consent will be completed after explanation of each treatment group and the data to be collected. Patient age, gender, BMI, and American Society of Anesthesiologists (ASA) score will be recorded as baseline demographic data.

Patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: Group 1 will receive interscalene nerve block, Group 2 will receive liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site. The surgeon will perform randomization when the patient enters the preoperative area.

The surgeon at each site will be trained prior to enrollment on the correct way to perform Exparel injections intraoperatively. Patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.

Surgical time, type of implant, incision length, and amount of anesthesia required will be recorded for each patient.

Patients will record their pain scores, medication and side effects data after surgery until 96 hours after surgery. Our primary analysis data points for pain scores and pain medication use will be 24 hours, 48 hours, 72 hours, 96 hours, and 2 weeks after surgery. The outcome assessor on the study team will be blinded to the treatment group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Interscalene Nerve Block
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Drug: Interscalene Nerve Block
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.

Experimental: Liposomal Bupivacaine
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Drug: Liposomal bupivacaine
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Other Name: Exparel




Primary Outcome Measures :
  1. Visual analog scale pain score [ Time Frame: 96 hours after surgery ]
    Pain levels recorded every 6 hours until 96 hours after surgery using visual analog scale.


Secondary Outcome Measures :
  1. Pain medication consumption in morphine equivalents [ Time Frame: 96 hours after surgery ]
    Inpatient pain medication recorded in electronic medical record and outpatient pain medications recorded by patients until 96 hours after surgery.

  2. Length of hospital stay [ Time Frame: Up to day of discharge from hospital (expected hospital stay of 2 days) ]
    Admission and discharge times and dates recorded in the electronic medical record.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons.
  • Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.

Exclusion Criteria:

  • Allergy to liposomal bupivacaine
  • Contraindications to the interscalene nerve block such as:
  • Preexisting neurologic defects
  • Local anesthetic allergy
  • Coagulopathy
  • Contralateral phrenic nerve dysfunction
  • Severe chronic obstructive pulmonary disease

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): NCT02762071


Locations
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United States, Maryland
Johns Hopkins Recruiting
Columbia, Maryland, United States, 21044
Contact: Iman Ali    443-546-1555    ial9@jhmi.edu   
Contact: Sanjana Vattigunta    443-546-1584    svattig1@jhmi.edu   
Principal Investigator: Uma Srikumaran, MD, MBA         
Sponsors and Collaborators
Johns Hopkins University
University of Texas Southwestern Medical Center
Southern Maryland Orthopaedic & Sports Medicine Center
William Beaumont Army Medical Center
Investigators
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Principal Investigator: Uma Srikumaran, MD, MBA Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02762071     History of Changes
Other Study ID Numbers: IRB00063657
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Shoulder Pain
Joint Diseases
Fractures, Closed
Musculoskeletal Diseases
Arthralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Fractures, Bone
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents