ClinicalTrials.gg
Sign In
TerminatedNCT04826484Baby ORIOLESUpdated Dec 26, 2023Results posted

Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

A Phase 3 interventional study of Exparel 133 miligrams per 10 milliliter injection and Bupivacaine Hydrochloride in Urologic Diseases, Hypospadias and Undescended Testes, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Johns Hopkins University · Phase 3, Interventional, and Treatment

Why this study was terminated
Met futility threshold at interim analysis
Phase
Phase 3
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Urologic Diseases
  • Hypospadias
  • Undescended Testes
  • Chordee
  • Hydrocele
  • Orchiectomy
03

In context

Urologic Diseases

221 studies on the registry are indexed under Urologic Diseases; 48 are open to participants now.

This study's enrollment of 104 is above the median of 80 across 160 interventional studies indexed under Urologic Diseases.

Browse Urologic Diseases studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Browse Johns Hopkins University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    Liposomal Bupivacaine plus 0.25% Bupivacaine

    Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine

    Drug: Exparel 133 miligrams per 10 milliliter injection · Drug: Bupivacaine Hydrochloride

  • Active comparator
    0.25% Bupivacaine alone

    Participants will receive local wound infiltration with 0.25% Bupivacaine alone.

    Drug: Bupivacaine Hydrochloride

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.

06

What researchers measure

Primary outcomes

  1. Percentage of Patients Who Are Opiate-free

    Percentage of patients who are opiate-free at 48 hours postoperatively.

    Time frame: 48 hours postoperatively

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. Percentage of Patients With Leftover Opioid Medication

    Percentage of patients with leftover opioid medication

    Time frame: 10-14 days postoperatively

  3. 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

07

Results

Posted Dec 26, 2023
Limitations and caveats
The trial met the predetermined threshold for early stopping. 1. Inability to blind surgeons due to differences in the appearance of the agents. 2. Unclear if the absorption profile of intervention is more rapid in groin/dorsal penile tissue compared to other areas. 3. Our cohort was enriched with low morbidity procedures which may have decreased differences between arms 4. Inability to compare the efficacy of the agents stratified by procedure type due to low enrollment in each procedure

Participant flow

Participant flow — Overall Study
MilestoneLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Started5252
Completed5052
Not completed20
Withdrew: Lost to follow-up20

Outcome measures

PrimaryPercentage of Patients Who Are Opiate-free

Percentage of patients who are opiate-free at 48 hours postoperatively.

Time frame:
48 hours postoperatively
Reported as:
Number · percentage of patients opioid-free
Percentage of Patients Who Are Opiate-free
percentage of patients opioid-freeLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Percentage of Patients Who Are Opiate-free6062
PrimaryPercentage 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
Reported as:
Number · percentage of pt opioid-free at 10-14d
Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively
percentage of pt opioid-free at 10-14dLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively6062
PrimaryParents' 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
Reported as:
Median · score on a scale
Parents' Postoperative Pain Measure (PPPM) Scores
score on a scaleLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Parents' Postoperative Pain Measure (PPPM) Scores2 (1 to 3)2.5 (2 to 4)
PrimaryParents' 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
Reported as:
Median · score on a scale
Parents' Postoperative Pain Measure (PPPM) Scores
score on a scaleLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Parents' Postoperative Pain Measure (PPPM) Scores0 (0 to 1)0 (0 to 1)
SecondaryAmount of Opioid Medication Used Post-discharge

Weight based amount of opioid medication (in OMEQ/kg) used post-discharge.

Time frame:
10-14 days postoperatively
Reported as:
Median · Oral morphine equivalent per kg (OMEQ/kg
Amount of Opioid Medication Used Post-discharge
Oral morphine equivalent per kg (OMEQ/kgLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Amount of Opioid Medication Used Post-discharge0 (0 to 0.1)0 (0 to 0.22)
SecondaryPercentage of Patients With Leftover Opioid Medication

Percentage of patients with leftover opioid medication

Time frame:
10-14 days postoperatively
Reported as:
Number · % of patients with leftover opiates
Percentage of Patients With Leftover Opioid Medication
% of patients with leftover opiatesLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Percentage of Patients With Leftover Opioid Medication1424
SecondaryCumulative 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
Reported as:
Count of participants · Participants
Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity
ParticipantsLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity00

Adverse events

Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liposomal Bupivacaine Plus 0.25% Bupivacaine0/52 (0%)0/52 (0%)7/52 (13.5%)
0.25% Bupivacaine Alone0/52 (0%)0/52 (0%)5/52 (9.6%)
Most frequent other events
Most frequent other events
EventLiposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine Alone
Postoperative swellingRenal and urinary disorders6/525/52
Penile HematomaRenal and urinary disorders1/520/52

Baseline characteristics

Age, Continuous
Age, Continuous(years)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
Median9.5 (8 to 13)11 (8 to 12)10 (8 to 12)
Sex: Female, Male
Sex: Female, Male(Participants)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
Female000
Male5252104
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
Race — Caucasian293261
Race — African American13720
Race — Asian5914
Race — LatinX/Hispanic549
Region of Enrollment
Region of Enrollment(Participants)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
United States5252104
Body Mass Index
Body Mass Index(kg/m^2)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
Median18.5 (16 to 21)18.6 (16 to 20)18.5 (16 to 20)
Procedure Type
Procedure Type(Participants)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
Orchiopexy202141
Circumcision202242
Distal Hypospadias Repair011
Inguinal Hernia Repair/Hydrocelectomy5712
Penile Cyst Excision101
Chordee Repair617
Postoperative Pain Management Strategies
Postoperative Pain Management Strategies(participants)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
Ketoralac303868
Tylenol484795
Ibuprofen plus Tylenol322961
Surgeon Performing Procedure
Surgeon Performing Procedure(Participants)Liposomal Bupivacaine Plus 0.25% Bupivacaine0.25% Bupivacaine AloneTotal
Surgeon 114923
Surgeon 271724
Surgeon 391120
Surgeon 4221537
08

Study locations

1 site
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2021 to primary completion in Apr 2023, 18 months.

Results were first posted in Dec 2023, 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2021
First posted
Apr 1, 2021
StartActual
Oct 1, 2021
Primary completionActual
Apr 26, 2023
CompletionActual
Apr 26, 2023
Results first posted
Dec 26, 2023
Last update
Dec 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04826484
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Oct 1, 2021
Primary completion
Apr 26, 2023
Completion
Apr 26, 2023
Results posted
Dec 26, 2023
Last update
Dec 26, 2023

Study contacts

Heather N DiCarlo, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urologic Diseases →

Other studies from this sponsor

Johns Hopkins University →

Start the discussion