Trial Outcomes & Findings for Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel (NCT NCT04826484)
NCT ID: NCT04826484
Last Updated: 2023-12-26
Results Overview
Percentage of patients who are opiate-free at 48 hours postoperatively.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
104 participants
Primary outcome timeframe
48 hours postoperatively
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=52 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.5 years
n=5 Participants
|
11 years
n=7 Participants
|
10 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · LatinX/Hispanic
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Body Mass Index
|
18.5 kg/m^2
n=5 Participants
|
18.6 kg/m^2
n=7 Participants
|
18.5 kg/m^2
n=5 Participants
|
|
Procedure Type
Orchiopexy
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Procedure Type
Circumcision
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Procedure Type
Distal Hypospadias Repair
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Procedure Type
Inguinal Hernia Repair/Hydrocelectomy
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Procedure Type
Penile Cyst Excision
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Procedure Type
Chordee Repair
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Postoperative Pain Management Strategies
Ketoralac
|
30 participants
n=5 Participants
|
38 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Postoperative Pain Management Strategies
Tylenol
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Postoperative Pain Management Strategies
Ibuprofen plus Tylenol
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Surgeon Performing Procedure
Surgeon 1
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Surgeon Performing Procedure
Surgeon 2
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Surgeon Performing Procedure
Surgeon 3
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Surgeon Performing Procedure
Surgeon 4
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours postoperativelyPercentage of patients who are opiate-free at 48 hours postoperatively.
Outcome measures
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=52 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Percentage of Patients Who Are Opiate-free
|
60 percentage of patients opioid-free
|
62 percentage of patients opioid-free
|
PRIMARY outcome
Timeframe: 10-14 days postoperativelyPopulation: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Outcome measures
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=50 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively
|
60 percentage of pt opioid-free at 10-14d
|
62 percentage of pt opioid-free at 10-14d
|
PRIMARY outcome
Timeframe: 48 hours postoperatively15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.
Outcome measures
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=52 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Parents' Postoperative Pain Measure (PPPM) Scores
|
2 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 2.0 to 4.0
|
PRIMARY outcome
Timeframe: 10-14 days postoperativelyPopulation: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain.
Outcome measures
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=50 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Parents' Postoperative Pain Measure (PPPM) Scores
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 10-14 days postoperativelyPopulation: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
Weight based amount of opioid medication (in OMEQ/kg) used post-discharge.
Outcome measures
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=50 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Amount of Opioid Medication Used Post-discharge
|
0 Oral morphine equivalent per kg (OMEQ/kg
Interval 0.0 to 0.1
|
0 Oral morphine equivalent per kg (OMEQ/kg
Interval 0.0 to 0.22
|
SECONDARY outcome
Timeframe: 10-14 days postoperativelyPopulation: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
Percentage of patients with leftover opioid medication
Outcome measures
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=50 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Percentage of Patients With Leftover Opioid Medication
|
14 % of patients with leftover opiates
|
24 % of patients with leftover opiates
|
SECONDARY outcome
Timeframe: 10-14 days postoperativelyPopulation: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
Cumulative incidence of complications related to local anesthetic systemic toxicity
Outcome measures
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=50 Participants
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 Participants
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity
|
0 Participants
|
0 Participants
|
Adverse Events
Liposomal Bupivacaine Plus 0.25% Bupivacaine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
0.25% Bupivacaine Alone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine Plus 0.25% Bupivacaine
n=52 participants at risk
Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine
Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
0.25% Bupivacaine Alone
n=52 participants at risk
Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
|
|---|---|---|
|
Renal and urinary disorders
Postoperative swelling
|
11.5%
6/52 • Number of events 6 • 1 month
|
9.6%
5/52 • Number of events 5 • 1 month
|
|
Renal and urinary disorders
Penile Hematoma
|
1.9%
1/52 • Number of events 1 • 1 month
|
0.00%
0/52 • 1 month
|
Additional Information
Andrew T. Gabrielson, MD
Johns Hopkins University School of Medicine
Phone: 410-955-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place