Trial Outcomes & Findings for Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures (NCT NCT02805504)

Last Updated: 2024-04-24

Results Overview

Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

136 participants

Primary outcome timeframe

Postoperative days 1-3

Results posted on

2024-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Exparel This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.	Marcaine This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Overall Study STARTED	63	73
Overall Study COMPLETED	63	73
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exparel n=63 Participants This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.	Marcaine n=73 Participants This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	38 Participants n=7 Participants	68 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Age, Continuous	61.6 years STANDARD_DEVIATION 12.3 • n=5 Participants	62.7 years STANDARD_DEVIATION 10.7 • n=7 Participants	62.2 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	48 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	63 Participants n=5 Participants	73 Participants n=7 Participants	136 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants	73 participants n=7 Participants	136 participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative days 1-3

Population: During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.

Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively

Outcome measures

Outcome measures
Measure	Exparel n=53 Participants This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.	Marcaine n=55 Participants This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.
Total Opioid Consumption	16.4 morphine equivalent Standard Deviation 19.4	15.3 morphine equivalent Standard Deviation 16.2

PRIMARY outcome

Timeframe: Postoperative day 1

Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.

Outcome measures

Outcome measures
Measure	Exparel n=53 Participants This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.	Marcaine n=55 Participants This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.
Postoperative Pain Assessment	4.6 units on a scale Standard Deviation 2.1	4.6 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: Duration of stay in hours

Duration of hospital stay after the surgery until time of discharge

Outcome measures

Outcome measures
Measure	Exparel n=53 Participants This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.	Marcaine n=55 Participants This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.
Length of Hospital Stay	37 Hours Standard Deviation 31.8	36 Hours Standard Deviation 24

PRIMARY outcome

Timeframe: 30 days postoperatively

Any complication related to the surgery within 30 days

Outcome measures

Outcome measures
Measure	Exparel n=53 Participants This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.	Marcaine n=55 Participants This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. No reportable study outcome data is available per IRB determination after study closure.
Postoperative Complications	6 Participants	6 Participants

Adverse Events

Exparel

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Marcaine

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Exparel n=63 participants at risk This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.	Marcaine n=73 participants at risk This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Gastrointestinal disorders Postoperative Ileus	6.3% 4/63 • 30-days postoperatively	5.5% 4/73 • 30-days postoperatively
Surgical and medical procedures Postoperative Bleeding	1.6% 1/63 • 30-days postoperatively	0.00% 0/73 • 30-days postoperatively
Surgical and medical procedures Postoperative Hypotension	1.6% 1/63 • 30-days postoperatively	1.4% 1/73 • 30-days postoperatively
Renal and urinary disorders Stricture	0.00% 0/63 • 30-days postoperatively	1.4% 1/73 • 30-days postoperatively

Other adverse events

Adverse event data not reported

Additional Information

Duane Baldwin, MD Director of Urologic Research

Loma Linda University Health

Phone: 909 558 4196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place