RCR: Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT03587584
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
34.5
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Arthroscopic Rotator Cuff Repair Surgery: A Randomized Controlled Trial
Actual Study Start Date :
Jul 25, 2018
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
Jun 8, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: liposomal bupivacaine

These patients receive an interscalene block with liposomal bupivacaine.

Drug: liposomal bupivacaine
Experimental

Active Comparator: bupivacaine

These patients receive an interscalene block with bupivacaine.

Drug: Bupivacaine
Active Comparator

Outcome Measures

Primary Outcome Measures

  1. Total post-operative opioids sued [time from end of surgery through 72 hours after end of surgery]

    Total amount of opioid medications used during the post-operative period through 72 hours. Opioids normalized to total morphine equivalents.

Secondary Outcome Measures

  1. Total maximal pain scores [time from end of surgery through 72 hours after end of surgery]

    Sum total of maximal pain scores using numerical rating scale 0-10. 0 is best 10 is worst

Other Outcome Measures

  1. overall benefit of analgesia score [survey taken at 72 hours after end of surgery]

    score on overall benefit of analgesia survey. Range 0-28. Higher is worse outcome

  2. quality of recovery 15 score [survey taken at 72 hours after end of surgery]

    score on quality of recovery 15 survey. Range 0-150. Higher is better

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of MinnesotaMinneapolisMinnesotaUnited States55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Tenzin Desa, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT03587584
Other Study ID Numbers:
  • ANES-2018-26660
First Posted:
Jul 16, 2018
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021