RCR: Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair

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

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 Disease	Intervention/Treatment	Phase
Acute Pain	Drug: liposomal bupivacaine; Drug: Bupivacaine	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

Arm	Intervention/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 Intraoperative Opioids Used [through end of surgery]

   Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.

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

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Tenzin Desa, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 11, 2020
• Informed Consent Form - May 11, 2020

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: Jul 27, 2022
• Last Verified: Jul 1, 2022

• 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: Acute Pain; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine
Arm/Group Description	These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
Period Title: Overall Study
STARTED	37	42
COMPLETED	33	33
NOT COMPLETED	4	9

Baseline Characteristics

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine	Total
Arm/Group Description	These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator	Total of all reporting groups
Overall Participants	37	42	79
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 81.1%	36 85.7%	66 83.5%
>=65 years	7 18.9%	6 14.3%	13 16.5%
Sex: Female, Male (Count of Participants)
Female	22 59.5%	26 61.9%	48 60.8%
Male	15 40.5%	16 38.1%	31 39.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine
Arm/Group Description	These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
Measure Participants	33	33
Intraoperative Fentanyl (mg)	.1	.1
Intraoperative MME (mg)	30	30
Intraoperative hydromorphone (mg)	0	0
Intraoperative ketamine	0	0
Intraoperative ketorolac (mg)	0	0

Adverse Events

Time Frame	72 hours
Arm/Group Title	Liposomal Bupivacaine		Bupivacaine
Arm/Group Description	These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental		These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
All Cause Mortality
	Liposomal Bupivacaine		Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Serious Adverse Events
	Liposomal Bupivacaine		Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Liposomal Bupivacaine		Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/33 (18.2%)		6/33 (18.2%)
Gastrointestinal disorders
Nausea	5/33 (15.2%)	5	4/33 (12.1%)	4
Vomiting	1/33 (3%)	1	2/33 (6.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.