Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair (RCR)
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
liposomal bupivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- Adult patients aged greater than 18 years of age that are undergoing arthroscopic rotator cuff surgery
Exclusion Criteria:
- Patients with allergy to local anesthetics
- Patients with daily use of opioids for more than 3 weeks prior to surgery
- Patients who refuse
- Patients with coagulopathy
- Patients who are non-english speaking
- Patients who do not have access to a telephone
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
liposomal bupivacaine
bupivacaine
Arm Description
These patients receive an interscalene block with liposomal bupivacaine.
These patients receive an interscalene block with bupivacaine.
Outcomes
Primary Outcome Measures
Total Intraoperative Opioids Used
Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03587584
Brief Title
Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair
Acronym
RCR
Official Title
Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Arthroscopic Rotator Cuff Repair Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
June 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
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
No
5. Study Description
Brief Summary
The purpose of this study is to compare pain control after arthroscopic rotator cuff repair surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these types of surgeries.
Detailed Description
All patients will receive preoperative oral multimodal medications consisting of acetaminophen 975 mg, gabapentin 300 mg, and Celebrex 400 mg.
After completion of the preoperative process the patient will be placed in the supine position with the head of the bed elevated 30 degrees with standard ASA monitors applied. Sedation will be provided with midazolam 0-2 mg and propofol 50 mg. The interscalene groove will be identified with the ultrasound. Using sterile technique, a 21g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is in the interscalene groove. Once in the interscalene, 20 mL of local anesthetic will be injected, with 10 mL deposited at the top of the brachial plexus and 10 mL at the bottom. In the study group, 5 mL of each 0.5% bupivacaine and LB will be injected at each location. The control group with have 20 mL of 0.5% bupivacaine divided between the injection sites. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure. A working block prior to surgery will be confirmed via sensory testing of the shoulder.
All patients will undergo a standard induction with propofol 1.5-3.0 mg/kg, ondansetron 4 mg, dexamethasone 10 mg and ketamine 0.25 mg/kg. A MAC or general with LMA or ETT will be placed and an opioid sparing technique will occur. Standardized maintenance will be a propofol infusion without neuromuscular blockers. 25-50 mcg of IV Fentanyl will be utilized for increases in heart rate greater than 20% or increases in systolic blood pressure above baseline.
Once in the operating room the surgeon will use 10 mL of 0.25% bupivacaine for skin, subcutaneous, and intraarticular injection.
When the operation is complete, the patient will be woken up and brought to the PACU. There the patient will receive IV fentanyl for a pain score of greater than 7. If more than 100 mcg of fentanyl is given and pain still remains above a 7 then IV hydromorphone will be used. A dose of 5-10 mg of oral oxycodone (or 2-4 mg of oral hydromorphone) will be given as soon as the patient is able to tolerate oral medication per standard protocol: If their pain score is 4-6 (on the Visual Analog Scale) then 5mg oral oxycodone (2 mg hydromorphone) can be administered, if their pain is between 7 to 10 then 10 mg of oxycodone (or 4 mg of hydromorphone) can be administered. Once the patient meets discharge criteria, they will be discharged home where each day they will fill out a pain diary. Additionally, a member of the research team will call the patient for signs of complications and ask the patient their current pain score, total opioid pills taken and non-opioid pain medication taken at 24, 48, and 72 hours postoperatively. Additionally, they will perform a Quality of Recovery Score survey at 72 hours, and 14 days postoperatively. An Ultrasound of the diaphragm will be completed by a blinded anesthesiologist in the PACU to assess diaphragm function.
All patients will be discharged with acetaminophen 975 mg q6 hours & ibuprofen 600 mg q6 hours, taken in intervals such that the patient is taking one of these medications every 3 hours. And then hydromorphone 2mg pills #60 dosing 1-2 pills q4 hours prn severe pain or oxycodone 5 mg pills #60 dosing 1-2 pills q 4 hours prn severe pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liposomal bupivacaine
Arm Type
Experimental
Arm Description
These patients receive an interscalene block with liposomal bupivacaine.
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
These patients receive an interscalene block with bupivacaine.
Intervention Type
Drug
Intervention Name(s)
liposomal bupivacaine
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
Total Intraoperative Opioids Used
Description
Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.
Time Frame
through end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients aged greater than 18 years of age that are undergoing arthroscopic rotator cuff surgery
Exclusion Criteria:
Patients with allergy to local anesthetics
Patients with daily use of opioids for more than 3 weeks prior to surgery
Patients who refuse
Patients with coagulopathy
Patients who are non-english speaking
Patients who do not have access to a telephone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tenzin Desa
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35190468
Citation
Flaherty JM, Berg AA, Harrison A, Braman J, Pearson JM, Matelich B, Kaizer AM, Hutchins JL. Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial. Reg Anesth Pain Med. 2022 May;47(5):309-312. doi: 10.1136/rapm-2021-103349. Epub 2022 Feb 21.
Results Reference
derived
Learn more about this trial
Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair
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