Chordee, Hydrocele, Hypospadias, Orchiectomy, Undescended Testes, Urologic Diseases
Conditions
Brief summary
This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.
Interventions
DRUGExparel 133 miligrams per 10 milliliter injection
Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection
DRUGBupivacaine Hydrochloride
Local wound infiltration with 0.25% bupivacaine.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pediatric patients 6 years and older undergoing minor pediatric urologic surgery * Patients who are otherwise eligible to receive routine care following minor urologic surgery
Exclusion criteria
* Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction) * Pediatric patients younger than 6 years of age * Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication * Unwilling to participate in 48 hours and 10-14 day follow-up phone calls
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Are Opiate-free | 48 hours postoperatively | Percentage of patients who are opiate-free at 48 hours postoperatively. |
| Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively | 10-14 days postoperatively | Percentage of patients who are opiate-free at 10-14 days postoperatively. |
| Parents' Postoperative Pain Measure (PPPM) Scores | 48 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Opioid Medication Used Post-discharge | 10-14 days postoperatively | Weight based amount of opioid medication (in OMEQ/kg) used post-discharge. |
| Percentage of Patients With Leftover Opioid Medication | 10-14 days postoperatively | Percentage of patients with leftover opioid medication |
| Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity | 10-14 days postoperatively | Cumulative incidence of complications related to local anesthetic systemic toxicity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 0.25% Bupivacaine Alone Participants will receive local wound infiltration with 0.25% Bupivacaine alone.
Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine. | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Total | 0.25% Bupivacaine Alone | Liposomal Bupivacaine Plus 0.25% Bupivacaine |
|---|---|---|---|
| Age, Continuous | 10 years | 11 years | 9.5 years |
| Body Mass Index | 18.5 kg/m^2 | 18.6 kg/m^2 | 18.5 kg/m^2 |
| Postoperative Pain Management Strategies Ibuprofen plus Tylenol | 61 participants | 29 participants | 32 participants |
| Postoperative Pain Management Strategies Ketoralac | 68 participants | 38 participants | 30 participants |
| Postoperative Pain Management Strategies Tylenol | 95 participants | 47 participants | 48 participants |
| Procedure Type Chordee Repair | 7 Participants | 1 Participants | 6 Participants |
| Procedure Type Circumcision | 42 Participants | 22 Participants | 20 Participants |
| Procedure Type Distal Hypospadias Repair | 1 Participants | 1 Participants | 0 Participants |
| Procedure Type Inguinal Hernia Repair/Hydrocelectomy | 12 Participants | 7 Participants | 5 Participants |
| Procedure Type Orchiopexy | 41 Participants | 21 Participants | 20 Participants |
| Procedure Type Penile Cyst Excision | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race African American | 20 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Race Asian | 14 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Caucasian | 61 Participants | 32 Participants | 29 Participants |
| Race/Ethnicity, Customized Race LatinX/Hispanic | 9 Participants | 4 Participants | 5 Participants |
| Region of Enrollment United States | 104 Participants | 52 Participants | 52 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 104 Participants | 52 Participants | 52 Participants |
| Surgeon Performing Procedure Surgeon 1 | 23 Participants | 9 Participants | 14 Participants |
| Surgeon Performing Procedure Surgeon 2 | 24 Participants | 17 Participants | 7 Participants |
| Surgeon Performing Procedure Surgeon 3 | 20 Participants | 11 Participants | 9 Participants |
| Surgeon Performing Procedure Surgeon 4 | 37 Participants | 15 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 7 / 52 | 5 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Parents' Postoperative Pain Measure (PPPM) Scores
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.
Time frame: 10-14 days postoperatively
Population: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine Plus 0.25% Bupivacaine | Parents' Postoperative Pain Measure (PPPM) Scores | 0 score on a scale |
| 0.25% Bupivacaine Alone | Parents' Postoperative Pain Measure (PPPM) Scores | 0 score on a scale |
Primary
Parents' Postoperative Pain Measure (PPPM) Scores
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.
Time frame: 48 hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine Plus 0.25% Bupivacaine | Parents' Postoperative Pain Measure (PPPM) Scores | 2 score on a scale |
| 0.25% Bupivacaine Alone | Parents' Postoperative Pain Measure (PPPM) Scores | 2.5 score on a scale |
Primary
Percentage of Patients Who Are Opiate-free
Percentage of patients who are opiate-free at 48 hours postoperatively.
Time frame: 48 hours postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine Plus 0.25% Bupivacaine | Percentage of Patients Who Are Opiate-free | 60 percentage of patients opioid-free |
| 0.25% Bupivacaine Alone | Percentage of Patients Who Are Opiate-free | 62 percentage of patients opioid-free |
Primary
Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively
Percentage of patients who are opiate-free at 10-14 days postoperatively.
Time frame: 10-14 days postoperatively
Population: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine Plus 0.25% Bupivacaine | Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively | 60 percentage of pt opioid-free at 10-14d |
| 0.25% Bupivacaine Alone | Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively | 62 percentage of pt opioid-free at 10-14d |
Secondary
Amount of Opioid Medication Used Post-discharge
Weight based amount of opioid medication (in OMEQ/kg) used post-discharge.
Time frame: 10-14 days postoperatively
Population: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine Plus 0.25% Bupivacaine | Amount of Opioid Medication Used Post-discharge | 0 Oral morphine equivalent per kg (OMEQ/kg |
| 0.25% Bupivacaine Alone | Amount of Opioid Medication Used Post-discharge | 0 Oral morphine equivalent per kg (OMEQ/kg |
Secondary
Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity
Cumulative incidence of complications related to local anesthetic systemic toxicity
Time frame: 10-14 days postoperatively
Population: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine Plus 0.25% Bupivacaine | Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity | 0 Participants |
| 0.25% Bupivacaine Alone | Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity | 0 Participants |
Secondary
Percentage of Patients With Leftover Opioid Medication
Percentage of patients with leftover opioid medication
Time frame: 10-14 days postoperatively
Population: Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine Plus 0.25% Bupivacaine | Percentage of Patients With Leftover Opioid Medication | 14 % of patients with leftover opiates |
| 0.25% Bupivacaine Alone | Percentage of Patients With Leftover Opioid Medication | 24 % of patients with leftover opiates |