A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion

NCT07839039 | Not Yet Recruiting

• 1 other identifier: STUDY00006276
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours after surgery

Secondary Outcomes (3)

• Postoperative opioid consumption

  72 hours after surgery

• Epidural leakage

  72 hours after surgery

• Hypotension

  72 hours after surgery

Study Arms (2)

Continuous epidural infusion (CEI)

ACTIVE COMPARATOR

A continuous infusion of anesthetic medication through an epidural catheter.

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.

Drug: Ropivacaine (Epidural analgesia) intermittent bolus; Drug: Chloroprocaine intermittent bolus

Interventions

Ropivacaine (Epidural analgesia) intermittent bolus DRUG

Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 mL/kg every 60 minutes

Programmed intermittent epidural bolus (PIEB)

Ropivacaine (Epidural analgesia) continuous infusion DRUG

Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 ml/kg/hr

Continuous epidural infusion (CEI)

Chloroprocaine intermittent bolus DRUG

Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.25 ml/kg every 30 minutes

Programmed intermittent epidural bolus (PIEB)

Chloroprocaine continuous infusion DRUG

Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.5 ml/kg/hr

Continuous epidural infusion (CEI)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Giorgio Veneziano: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Bladder Exstrophy

Interventions

Ropivacaine; Analgesia, Epidural

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesia; Anesthesia and Analgesia

Study Officials

• Giorgio Veneziano, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Rice-Weimer, BSN

CONTACT

614-355-3142; julie.rice-weimer@nationwidechildrens.org

Catherine Roth, MPH

CONTACT

614-722-2997; catherine.roth@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Comprehensive Pain Services

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)