A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion

N/ANot Yet RecruitingNCT07839039

Giorgio Veneziano10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bladder Extrophy Surgery in Children

Interventions

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

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Postoperative pain score

Average pain score after surgery

Time frame: 72 hours after surgery

Secondary Outcomes

Postoperative opioid consumption

Cumulative postoperative opioid consumption in morphine millequivalents.

Time frame: 72 hours after surgery

Epidural leakage

Incidence of local anesthetic leaking from epidural.

Time frame: 72 hours after surgery

Hypotension

Incidence of postoperative hypotension requiring intervention.

Time frame: 72 hours after surgery

Central 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

Data from ClinicalTrials.gov

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