Acute Pain
Conditions
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.
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.
Interventions
interscalene block with liposomal bupivacaine plus bupivacaine
DRUGBupivacaine
interscalene block with bupivacaine
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment ceased after 70 patients completed the study per protocol
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Interscalene Block 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance.
Bupivacaine: interscalene block with bupivacaine | 38 |
| 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
liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine | 37 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 5 |
Baseline characteristics
| Characteristic | Bupivacaine Interscalene Block | Liposome Bupivacaine Interscalene Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 23 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 15 Participants | 37 Participants |
| Sex: Female, Male Male | 16 Participants | 22 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 33 |
| other Total, other adverse events | 7 / 37 | 0 / 33 |
| serious Total, serious adverse events | 0 / 37 | 0 / 33 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine Interscalene Block | Total Opioid Use | 22.5 mg (morphine equivalent) |
| Liposome Bupivacaine Interscalene Block | Total Opioid Use | 30.0 mg (morphine equivalent) |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine Interscalene Block | Total Maximum Pain Scores f | 4.0 score on a scale |
| Liposome Bupivacaine Interscalene Block | Total Maximum Pain Scores f | 3.0 score on a scale |