Trial Outcomes & Findings for Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management (NCT NCT04284930)

Results Overview

Post-op pain measured by total post-op Morphine equivalents

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

total hospital stay, an average of 3 days

Results posted on

2021-01-07

Participant Flow

The study was closed at interim analysis due to analyzed findings supporting use of exparel for pain control. We felt it would be unethical to continue to with overwhelming positive results.

Participant milestones

Participant milestones
Measure	Depobupivacaine Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.	OnQ Pump Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.	Bupivacaine Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. 0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
Overall Study STARTED	8	5	8
Overall Study COMPLETED	8	5	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depobupivacaine n=8 Participants Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.	OnQ Pump n=5 Participants Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.	Bupivacaine n=8 Participants Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. 0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.	Total n=21 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 7.1 • n=5 Participants	51.33 years STANDARD_DEVIATION 6.25 • n=7 Participants	50 years STANDARD_DEVIATION 5.7 • n=5 Participants	51.12 years STANDARD_DEVIATION 6.3 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race white	8 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	21 participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	21 participants n=4 Participants

PRIMARY outcome

Timeframe: total hospital stay, an average of 3 days

Post-op pain measured by total post-op Morphine equivalents

Outcome measures

Outcome measures
Measure	Depobupivacaine n=8 Participants Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.	OnQ Pump n=5 Participants Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.	Bupivacaine n=8 Participants Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. 0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
Total Narcotic Usage	0.8 mg/kg/day morphine Standard Deviation 0.5	.13 mg/kg/day morphine Standard Deviation .1	0.18 mg/kg/day morphine Standard Deviation 0.1

Adverse Events

Depobupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OnQ Pump

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Risal Djohan

Cleveland Clinic

Phone: 216 312-6146

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place