Trial Outcomes & Findings for Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty (NCT NCT05005260)
NCT ID: NCT05005260
Last Updated: 2024-05-07
Results Overview
Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
88 participants
Primary outcome timeframe
Post-Operative Day 1
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine Single-shot Interscalene Blockade
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
|
Continuous Interscalene Nerve Blockade
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
Bupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
46
|
|
Overall Study
COMPLETED
|
39
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine Single-shot Interscalene Blockade
n=39 Participants
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
|
Continuous Interscalene Nerve Blockade
n=44 Participants
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
Bupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=39 Participants
|
69 years
n=44 Participants
|
71 years
n=83 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
20 Participants
n=44 Participants
|
37 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
24 Participants
n=44 Participants
|
46 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ASA Score
ASA 1
|
1 participants
n=39 Participants
|
0 participants
n=44 Participants
|
1 participants
n=83 Participants
|
|
ASA Score
ASA 2
|
20 participants
n=39 Participants
|
26 participants
n=44 Participants
|
46 participants
n=83 Participants
|
|
ASA Score
ASA 3
|
18 participants
n=39 Participants
|
18 participants
n=44 Participants
|
36 participants
n=83 Participants
|
PRIMARY outcome
Timeframe: Post-Operative Day 1Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.
Outcome measures
| Measure |
Liposomal Bupivacaine Single-shot Interscalene Blockade
n=39 Participants
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
|
Continuous Interscalene Nerve Blockade
n=44 Participants
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
Bupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
|
|---|---|---|
|
Pain Intensity Score at Rest at 24 Hours Post-operatively
|
1 units on a scale
Interval 0.0 to 3.0
|
1 units on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: PACU to postoperative day 3Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3
Outcome measures
| Measure |
Liposomal Bupivacaine Single-shot Interscalene Blockade
n=39 Participants
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
|
Continuous Interscalene Nerve Blockade
n=44 Participants
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
Bupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
|
|---|---|---|
|
Cumulative Opioid Consumption
|
30.0 mg oral morphine equivalents
Interval 7.5 to 64.0
|
15.0 mg oral morphine equivalents
Interval 7.5 to 38.8
|
SECONDARY outcome
Timeframe: Post-Operative Day 115 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Outcome measures
| Measure |
Liposomal Bupivacaine Single-shot Interscalene Blockade
n=39 Participants
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
|
Continuous Interscalene Nerve Blockade
n=44 Participants
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
Bupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
|
|---|---|---|
|
Quality of Recovery Score (QoR)
|
126.0 score on a scale
Interval 113.0 to 133.0
|
124.0 score on a scale
Interval 111.0 to 132.5
|
Adverse Events
Liposomal Bupivacaine Single-shot Interscalene Blockade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Interscalene Nerve Blockade
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine Single-shot Interscalene Blockade
n=39 participants at risk
Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
|
Continuous Interscalene Nerve Blockade
n=44 participants at risk
Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
Bupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
|
|---|---|---|
|
Surgical and medical procedures
Leaking catheter
|
0.00%
0/39 • First 3 days after surgery
|
11.4%
5/44 • First 3 days after surgery
|
|
Surgical and medical procedures
Catheter dislodgement
|
0.00%
0/39 • First 3 days after surgery
|
2.3%
1/44 • First 3 days after surgery
|
|
Surgical and medical procedures
Non-functioning catheter
|
0.00%
0/39 • First 3 days after surgery
|
2.3%
1/44 • First 3 days after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place