Trial Outcomes & Findings for Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair (NCT NCT02128646)
NCT ID: NCT02128646
Last Updated: 2025-09-10
Results Overview
Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being "strongly disagree"/not satisfied with pain control and 5 being "strongly agree"/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
Change from Surgery to Day 14
Results posted on
2025-09-10
Participant Flow
Participant milestones
| Measure |
Laparoscopic Treatment Arm
Laparoscopic abdominal hernia repair with Exparel
|
Laparoscopic Control Arm
Laparoscopic abdominal hernia repair without Exparel
|
Open Treatment Arm
Open abdominal hernia repair with Exparel
|
Open Control Arm
Open abdominal hernia repair without Exparel
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
5
|
3
|
|
Overall Study
COMPLETED
|
7
|
4
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Different arms have different age ranges and number of participants.
Baseline characteristics by cohort
| Measure |
Laparoscopic Treatment Arm
n=7 Participants
All patients 18 and older presenting with an abdominal hernia requiring laparoscopic repair were screened for inclusion.
|
Laparoscopic Control Arm
n=4 Participants
All patients 18 and older presenting with an abdominal hernia requiring laparoscopic repair were screened for inclusion.
|
Open Treatment Arm
n=5 Participants
All patients 18 and older presenting with an abdominal hernia requiring open surgical repair were screened for inclusion.
|
Open Control Arm
n=3 Participants
All patients 18 and older presenting with an abdominal hernia requiring open surgical repair were screened for inclusion.
|
Total
n=19 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Continuous
|
60.5 years
n=5 Participants • Different arms have different age ranges and number of participants.
|
62 years
n=7 Participants • Different arms have different age ranges and number of participants.
|
74.5 years
n=5 Participants • Different arms have different age ranges and number of participants.
|
55.5 years
n=4 Participants • Different arms have different age ranges and number of participants.
|
64 years
n=21 Participants • Different arms have different age ranges and number of participants.
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from Surgery to Day 14Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being "strongly disagree"/not satisfied with pain control and 5 being "strongly agree"/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit.
Outcome measures
| Measure |
Laparoscopic Control Arm
n=4 Participants
Patients were eligible for opioid treatment during surgery and did not receive Exparel.
|
Laparoscopic Treatment Arm
n=7 Participants
Patients may have received Fentanyl during surgery, but all other opioids were prohibited. They all received 266 mg of Exparel, followed by 30 mg of IV Ketorolac when not contraindicated.
|
Open Control Arm
n=2 Participants
Patients were eligible for opioid treatment during surgery and did not receive Exparel.
|
Open Treatment Arm
n=5 Participants
Patients may have received Fentanyl during surgery, but all other opioids were prohibited. They all received 266 mg of Exparel, followed by 30 mg of IV Ketorolac when not contraindicated.
|
|---|---|---|---|---|
|
Patient Satisfaction With Pain Management After Surgery
|
4 score on a scale
Interval 3.5 to 4.0
|
4 score on a scale
Interval 4.0 to 5.0
|
2.5 score on a scale
Interval 2.0 to 3.0
|
5 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to 385 minutes after surgeryLength of time subjects stayed in the PACU following surgery
Outcome measures
| Measure |
Laparoscopic Control Arm
n=2 Participants
Patients were eligible for opioid treatment during surgery and did not receive Exparel.
|
Laparoscopic Treatment Arm
n=5 Participants
Patients may have received Fentanyl during surgery, but all other opioids were prohibited. They all received 266 mg of Exparel, followed by 30 mg of IV Ketorolac when not contraindicated.
|
Open Control Arm
n=4 Participants
Patients were eligible for opioid treatment during surgery and did not receive Exparel.
|
Open Treatment Arm
n=7 Participants
Patients may have received Fentanyl during surgery, but all other opioids were prohibited. They all received 266 mg of Exparel, followed by 30 mg of IV Ketorolac when not contraindicated.
|
|---|---|---|---|---|
|
Total Length of Time in Post-anesthesia Care Unit (PACU)
|
93.5 minutes
Interval 69.0 to 118.0
|
64 minutes
Interval 60.0 to 93.0
|
118 minutes
Interval 76.5 to 151.0
|
86 minutes
Interval 55.0 to 98.0
|
Adverse Events
Open Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laparoscopic Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laparoscopic Treatment Arm
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
Michael Moncure, MD
University of Kansas Medical Center
Phone: 913-588-1240
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place