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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
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 20, 2018
Last Updated
July 5, 2022
Sponsor
University of Minnesota
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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

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Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair

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