NCT03663283

Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

Completed Phase 4 Results posted Last updated 21 February 2021

What this trial tests

Phase 4 trial testing Liposomal Bupivacaine in Arthropathy Shoulder in 104 participants. Completed in 14 February 2020.

Timeline

29 October 2018

Primary endpoint
14 February 2020

14 February 2020

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	104
Start date	29 October 2018
Primary completion	14 February 2020
Estimated completion	14 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Liposomal Bupivacaine
• Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) — full drug profile →

Conditions studied

• Arthropathy Shoulder — all drugs for Arthropathy Shoulder →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Arthropathy Shoulder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Pain Scores Primary · 72 hours post-operatively

Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.

Group	Value	95% CI
Liposomal Bupivacaine	4.0	± 2.57
Plain Bupivacaine	2.8	± 1.88

Opioid Consumption Secondary · Measured at 72 hours and at 3 weeks post-operatively

Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks

72 hours

Group	Value	95% CI
Liposomal Bupivacaine	45.6	± 37.55
Plain Bupivacaine	56.2	± 35.43

3 weeks

Group	Value	95% CI
Liposomal Bupivacaine	133.9	± 110.52
Plain Bupivacaine	150.9	± 138.4

Time to Cessation of Nerve Blockade Secondary · 4, 8, 12, 16, 20, 24, and 28 hours post-operatively

Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.

4 hours

Group	Value	95% CI
Liposomal Bupivacaine	16
Plain Bupivacaine	12

8 hours

Group	Value	95% CI
Liposomal Bupivacaine	31
Plain Bupivacaine	19

12 hours

Group	Value	95% CI
Liposomal Bupivacaine	38
Plain Bupivacaine	28

16 hours

Group	Value	95% CI
Liposomal Bupivacaine	43
Plain Bupivacaine	35

20 hours

Group	Value	95% CI
Liposomal Bupivacaine	43
Plain Bupivacaine	41

24 hours

Group	Value	95% CI
Liposomal Bupivacaine	46
Plain Bupivacaine	44

28 hours

Group	Value	95% CI
Liposomal Bupivacaine	47
Plain Bupivacaine	45

Satisfaction With Pain Control Using Satisfaction Scale Secondary · Measured at 72 hours and at three weeks post-operatively

Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.

72 hours

Group	Value	95% CI
Liposomal Bupivacaine	6.6	± 2.74
Plain Bupivacaine	6.9	± 2.64

3 weeks

Group	Value	95% CI
Liposomal Bupivacaine	7.5	± 2.52
Plain Bupivacaine	7.8	± 2.23

Sponsor's own description

The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.