Liposomal Bupivacaine in Rotator Cuff Repair
Primary Purpose
Rotator Cuff Injury
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injury
Eligibility Criteria
Inclusion Criteria:
- Undergoing outpatient arthroscopic rotator cuff repair
- Greater than or equal to 19 years of age at the time of surgery
Exclusion Criteria:
- Planned operative fixation of the biceps tendon or acromioclavicular joint
- Opioid use 6 weeks before surgery
- Gabapentin use 6 weeks before surgery
- History of prior shoulder surgery on the operative limb
- Severe pulmonary dysfunction
- Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
- History of radicular pain or neuropathy in the operative limb
- Patients who are currently incapacitated for medical decision making
Sites / Locations
- UAB Hospital-HighlandsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposomal bupivacaine Interscalene Block
Ropivacaine Interscalene Catheter
Arm Description
Interscalene block: 10cc (133mg) liposomal bupivacaine;PLUS 10cc 0.25% bupivacaine
20cc 0.25% bupivacaine interscalene block; PLUS Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)
Outcomes
Primary Outcome Measures
Postoperative pain scores
Visual analog pain scores after operation [0-10, with 10 being the worst pain]
Secondary Outcome Measures
Postoperative oral morphine equivalents
oral morphine equivalents of all opioid-containing medications received
Analgesia Satisfaction
Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]
Analgesia Complications
Complications resulting from the method of analgesia utilized
Sleep quality
Likert scale of sleep quality [0-5, with 5 being the most satisfied]
Hours of painless sleep
Hours of sleep uninterrupted by pain [numerical, hours]
Full Information
NCT ID
NCT03738696
First Posted
November 7, 2018
Last Updated
November 30, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03738696
Brief Title
Liposomal Bupivacaine in Rotator Cuff Repair
Official Title
Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Pacira Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liposomal bupivacaine Interscalene Block
Arm Type
Experimental
Arm Description
Interscalene block:
10cc (133mg) liposomal bupivacaine;PLUS
10cc 0.25% bupivacaine
Arm Title
Ropivacaine Interscalene Catheter
Arm Type
Active Comparator
Arm Description
20cc 0.25% bupivacaine interscalene block; PLUS
Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)
Intervention Type
Drug
Intervention Name(s)
Exparel
Other Intervention Name(s)
liposomal bupivacaine
Intervention Description
A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Visual analog pain scores after operation [0-10, with 10 being the worst pain]
Time Frame
0-96 hrs postoperative
Secondary Outcome Measure Information:
Title
Postoperative oral morphine equivalents
Description
oral morphine equivalents of all opioid-containing medications received
Time Frame
0-96 hrs postoperative
Title
Analgesia Satisfaction
Description
Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]
Time Frame
0-96 hrs postoperative
Title
Analgesia Complications
Description
Complications resulting from the method of analgesia utilized
Time Frame
0-96 hrs postoperative
Title
Sleep quality
Description
Likert scale of sleep quality [0-5, with 5 being the most satisfied]
Time Frame
0-96 hrs postoperative
Title
Hours of painless sleep
Description
Hours of sleep uninterrupted by pain [numerical, hours]
Time Frame
0-96 hrs postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing outpatient arthroscopic rotator cuff repair
Greater than or equal to 19 years of age at the time of surgery
Exclusion Criteria:
Planned operative fixation of the biceps tendon or acromioclavicular joint
Opioid use 6 weeks before surgery
Gabapentin use 6 weeks before surgery
History of prior shoulder surgery on the operative limb
Severe pulmonary dysfunction
Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
History of radicular pain or neuropathy in the operative limb
Patients who are currently incapacitated for medical decision making
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra M Arguello, BS
Phone
7023754975
Email
aarguello@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Kit He, BA
Email
jkhe@uabmc.edu
Facility Information:
Facility Name
UAB Hospital-Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy Acton
Phone
205-996-6781
Email
christyacton@uabmc.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Liposomal Bupivacaine in Rotator Cuff Repair
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