A Phase 2 interventional study of liposome bupivacaine and Bupivacaine in Acute Pain, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment
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.
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 77 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.
Drug: Bupivacaine
interscalene block with liposomal bupivacaine plus bupivacaine
Also known as: bupivacaine
interscalene block with bupivacaine
Total Opioid Use
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
Total Maximum Pain Scores f
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
Recruitment ceased after 70 patients completed the study per protocol
| Milestone | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block |
|---|---|---|
| Started | 39 | 38 |
| Completed | 37 | 33 |
| Not completed | 2 | 5 |
| Withdrew: Lost to follow-up | 2 | 5 |
total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents
| mg (morphine equivalent) | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block |
|---|---|---|
| Total Opioid Use | 22.5 (7.5 to 96.0) | 30.0 (5.6 to 45.0) |
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
| score on a scale | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block |
|---|---|---|
| Total Maximum Pain Scores f | 4.0 (2.0 to 6.0) | 3.0 (1.0 to 5.5) |
Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupivacaine Interscalene Block | 0/37 (0%) | 0/37 (0%) | 7/37 (18.9%) |
| Liposome Bupivacaine Interscalene Block | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Event | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block |
|---|---|---|
| Fall weeks after surgeryEar and labyrinth disorders | 2/37 | 0/33 |
| Bruising/ swellingBlood and lymphatic system disorders | 2/37 | 0/33 |
| Balance Issues weeks after surgeryEar and labyrinth disorders | 1/37 | 0/33 |
| Numbness/ swellingNervous system disorders | 1/37 | 0/33 |
| Appendicitis several weeks after surgeryInfections and infestations | 1/37 | 0/33 |
Total of 75 included here due to dropouts along the way
| Age, Categorical(Participants) | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 14 | 29 |
| >=65 years | 23 | 23 | 46 |
| Sex: Female, Male(Participants) | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block | Total |
|---|---|---|---|
| Female | 22 | 15 | 37 |
| Male | 16 | 22 | 38 |
| Race and Ethnicity Not Collected(Participants) | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Minnesota