Liposome Bupivacaine Interscalene Total Shoulder

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03587636
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Actual Duration (Months): 30
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Drug: liposome bupivacaine; Drug: Bupivacaine	Phase 2

Detailed Description

Liposomal bupivacaine (LB) is a long acting local anesthetic. It is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. Bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. Both medications are standard of care for use in interscalene blocks here at the U of MN.

LB has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for Total Shoulder Arthroplasty (TSA) patients. It has been studied in Rotator Cuff Repairs (RCR) surgery and showed superior analgesia compared to bupivacaine.

The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Controlled Trial Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Total Shoulder Arthroplasty Surgery; a Pilot Study
• Actual Study Start Date: Sep 17, 2018
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liposome bupivacaine interscalene block 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance	Drug: liposome bupivacaine; interscalene block with liposomal bupivacaine plus bupivacaine; Other Names: bupivacaine
Active Comparator: bupivacaine interscalene block 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.	Drug: Bupivacaine; interscalene block with bupivacaine

Outcome Measures

Primary Outcome Measures

1. Total Opioid Use [From end of surgery through 72 hours after end of surgery]

   total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents

Secondary Outcome Measures

1. Total Maximum Pain Scores f [time from end of surgery through 72 hours after end of surgery]

   Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All adult patients aged greater than 18 years of age that are undergoing total or reverse total shoulder arthroplasty

Exclusion Criteria:

• Patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks prior to surgery, patient refusal, patient with coagulopathy, non-english speaking patients, and those 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: James Flaherty, MD, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 3, 2020
• Informed Consent Form - Mar 26, 2020

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03587636
• Other Study ID Numbers: ANES-2018-26661
• First Posted: Jul 16, 2018
• Last Update Posted: May 2, 2022
• Last Verified: Apr 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

Recruitment Details	Recruitment ceased after 70 patients completed the study per protocol

Arm/Group Title	Bupivacaine Interscalene Block	Liposome Bupivacaine Interscalene Block
Arm/Group Description	20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Period Title: Overall Study
STARTED	39	38
COMPLETED	37	33
NOT COMPLETED	2	5

Baseline Characteristics

Arm/Group Title	Bupivacaine Interscalene Block	Liposome Bupivacaine Interscalene Block	Total
Arm/Group Description	20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine	Total of all reporting groups
Overall Participants	38	37	75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 39.5%	14 37.8%	29 38.7%
>=65 years	23 60.5%	23 62.2%	46 61.3%
Sex: Female, Male (Count of Participants)
Female	22 57.9%	15 40.5%	37 49.3%
Male	16 42.1%	22 59.5%	38 50.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Total Opioid Use
Description	total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents
Time Frame	From end of surgery through 72 hours after end of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Interscalene Block	Liposome Bupivacaine Interscalene Block
Arm/Group Description	20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Measure Participants	37	33
Median (Inter-Quartile Range) [mg (morphine equivalent)]	22.5	30.0

2. Secondary Outcome

Title	Total Maximum Pain Scores f
Description	Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best
Time Frame	time from end of surgery through 72 hours after end of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Interscalene Block	Liposome Bupivacaine Interscalene Block
Arm/Group Description	20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Measure Participants	37	33
Median (Inter-Quartile Range) [score on a scale]	4.0	3.0

Adverse Events

Time Frame	72 hours
Arm/Group Title	Bupivacaine Interscalene Block		Liposome Bupivacaine Interscalene Block
Arm/Group Description	20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine		10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
All Cause Mortality
	Bupivacaine Interscalene Block		Liposome Bupivacaine Interscalene Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/33 (0%)
Serious Adverse Events
	Bupivacaine Interscalene Block		Liposome Bupivacaine Interscalene Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Bupivacaine Interscalene Block		Liposome Bupivacaine Interscalene Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/37 (18.9%)		0/33 (0%)
Blood and lymphatic system disorders
Bruising/ swelling	2/37 (5.4%)	2	0/33 (0%)	0
Ear and labyrinth disorders
Fall weeks after surgery	2/37 (5.4%)	2	0/33 (0%)	0
Balance Issues weeks after surgery	1/37 (2.7%)	1	0/33 (0%)	0
Infections and infestations
Appendicitis several weeks after surgery	1/37 (2.7%)	1	0/33 (0%)	0
Nervous system disorders
Numbness/ swelling	1/37 (2.7%)	1	0/33 (0%)	0

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.