Bladder ExtrophyNCT07839039
A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion
A study testing Ropivacaine (Epidural analgesia) intermittent bolus, Ropivacaine (Epidural analgesia) continuous infusion and Chloroprocaine intermittent bolus in people with Bladder Extrophy and Surgery in Children, run by Giorgio Veneziano at 1 site in United States.
Trial summary
The purpose of this study is to determine whether programmed intermittent epidural bolus (PIEB) offers advantages over continuous epidural infusion (CEI) in this pediatric post-surgical population by randomizing patients to receive either the PIEB or CEI pump modality for postoperative analgesia. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bladder Extrophy, Surgery in Children
- What is being tested?
- Ropivacaine (Epidural analgesia) intermittent bolus, Ropivacaine (Epidural analgesia) continuous infusion and Chloroprocaine intermittent bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age less than 18 years
- Kelly procedure or other approximating surgical interventions
- Expected need for postoperative epidural analgesia of at least 72 hours in duration
Who cannot join
- Spine abnormality or coagulopathy that contraindicates epidural catheter placement
- Perioperative anticoagulation regimen that is not recommended by the ASRA guidelines on concurrent use with neuraxial anesthesia
- Surgery is anticipated to require osteotomies
- Allergy to local anesthetic drug or other pain management drugs listed in protocol
- Allergy to chlorhexidine, Dermabond, or Tegaderm CHG dressing
- Opioid consumption within two weeks prior to surgery
Show all 9Show fewer
- Infection or rash over the epidural catheter insertion site
- Systemic bacterial or fungal infection requiring ongoing treatment with antibiotics
- Epidural pump unable to be initiated in the operating room or within 30 minutes of arrival to PACU.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: A Pilot Study Comparison of Postoperative Analgesia Using Two Modes of Local Anesthetic Epidural Delivery After Bladder Exstrophy Repair: Programmed Intermittent Bolus Versus Continuous Infusion
The purpose of this study is to determine whether programmed intermittent epidural bolus (PIEB) offers advantages over continuous epidural infusion (CEI) in this pediatric post-surgical population by randomizing patients to receive either the PIEB or CEI pump modality for postoperative analgesia. The comparative efficacy of the two interventions will be primarily determined by assessing pain scores at frequent intervals in the first three postoperative days. Secondary outcomes examined over this period will include opioid consumption, number of epidural pump interventions, incidence of epidural insertion site leakage and/or early catheter discontinuation, time to full diet, and incidence of postoperative hypotension.
- Conditions
- Bladder Extrophy, Surgery in Children
- Being tested
- Ropivacaine (Epidural analgesia) intermittent bolus, Ropivacaine (Epidural analgesia) continuous infusion, Chloroprocaine intermittent bolus, Chloroprocaine continuous infusion
- Medical subject headings
- Bladder Exstrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine (Epidural analgesia) intermittent bolusDrug
Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 mL/kg every 60 minutes
Ropivacaine (Epidural analgesia) continuous infusionDrug
Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 ml/kg/hr
Chloroprocaine intermittent bolusDrug
Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.25 ml/kg every 30 minutes
Chloroprocaine continuous infusionDrug
Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.5 ml/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| Continuous epidural infusion (CEI) | Active comparator | A continuous infusion of anesthetic medication through an epidural catheter. Receives: Drug: Ropivacaine (Epidural analgesia) continuous infusion; Drug: Chloroprocaine continuous infusion |
| Programmed intermittent epidural bolus (PIEB) | Experimental | Administering boluses of anesthetic medication through an epidural catheter on a scheduled interval without patient involvement. Receives: Drug: Ropivacaine (Epidural analgesia) intermittent bolus; Drug: Chloroprocaine intermittent bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Average pain score after surgery on a scale of 0-10. Zero being no pain and 10 being the worst pain imaginable.
Measured: 72 hours after surgery
Secondary outcomes (3)
Postoperative opioid consumption
Cumulative postoperative opioid consumption in morphine millequivalents.
Measured: 72 hours after surgery
Epidural leakage
Incidence of local anesthetic leaking from epidural.
Measured: 72 hours after surgery
Hypotension
Incidence of postoperative hypotension requiring intervention.
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder ExtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giorgio Veneziano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giorgio Veneziano, Nationwide Children's Hospital
- Investigators
- Giorgio Veneziano, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839039
- Sponsor's protocol ID
- STUDY00006276
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparison of Postoperative Analgesia Using Two Modes of Local Anesthetic Epidural Delivery After Bladder Exstrophy Repair: Programmed Intermittent Bolus Versus Continuous Infusion
- ClinicalTrials.gov ID
- NCT07839039
- Acronym / sponsor ID
- STUDY00006276
- Conditions
- Bladder Extrophy, Surgery in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Giorgio VenezianoUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether programmed intermittent epidural bolus (PIEB) offers advantages over continuous epidural infusion (CEI) in this pediatric post-surgical population by randomizing patients to receive either the PIEB or CEI pump modality for postoperative analgesia. The comparative efficacy of the two interventions will be primarily determined by assessing pain scores at frequent intervals in the first three postoperative days. Secondary outcomes examined over this period will include opioid consumption, number of epidural pump interventions, incidence of epidural insertion site leakage and/or early catheter discontinuation, time to full diet, and incidence of postoperative hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous epidural infusion (CEI) | Active comparator | Drug: Ropivacaine (Epidural analgesia) continuous infusion, Drug: Chloroprocaine continuous infusionA continuous infusion of anesthetic medication through an epidural catheter. |
| Programmed intermittent epidural bolus (PIEB) | Experimental | Drug: Ropivacaine (Epidural analgesia) intermittent bolus, Drug: Chloroprocaine intermittent bolusAdministering boluses of anesthetic medication through an epidural catheter on a scheduled interval without patient involvement. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age less than 18 years
- Kelly procedure or other approximating surgical interventions
- Expected need for postoperative epidural analgesia of at least 72 hours in duration
Key exclusion criteria (9 listed)
- Spine abnormality or coagulopathy that contraindicates epidural catheter placement
- Perioperative anticoagulation regimen that is not recommended by the ASRA guidelines on concurrent use with neuraxial anesthesia
- Surgery is anticipated to require osteotomies
- Allergy to local anesthetic drug or other pain management drugs listed in protocol
- Allergy to chlorhexidine, Dermabond, or Tegaderm CHG dressing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine (Epidural analgesia) intermittent bolusActual body weight greater than 15 kg: 0.2% ropivacaine 0.2 mL/kg every 60 minutes | Drug | Programmed intermittent epidural bolus (PIEB) |
| Ropivacaine (Epidural analgesia) continuous infusionActual body weight greater than 15 kg: 0.2% ropivacaine 0.2 ml/kg/hr | Drug | Continuous epidural infusion (CEI) |
| Chloroprocaine intermittent bolusActual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.25 ml/kg every 30 minutes | Drug | Programmed intermittent epidural bolus (PIEB) |
| Chloroprocaine continuous infusionActual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.5 ml/kg/hr | Drug | Continuous epidural infusion (CEI) |
Primary outcome
Postoperative pain score
Time frame: 72 hours after surgery
Average pain score after surgery on a scale of 0-10. Zero being no pain and 10 being the worst pain imaginable.
3 secondary outcomes
Postoperative opioid consumption
Time frame: 72 hours after surgery
Epidural leakage
Time frame: 72 hours after surgery
Hypotension
Time frame: 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giorgio Veneziano, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine (Epidural analgesia) intermittent bolus, Ropivacaine (Epidural analgesia) continuous infusion and Chloroprocaine intermittent bolus in people with Bladder Extrophy and Surgery in Children, run by Giorgio Veneziano at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Rice-Weimer, BSN (614-355-3142, julie.rice-weimer@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.