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A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion

ConditionsBladder ExtrophySurgery in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorGiorgio Veneziano

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine (Epidural analgesia) intermittent bolus

    Drug

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

  • Ropivacaine (Epidural analgesia) continuous infusion

    Drug

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

  • 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

  • Chloroprocaine continuous infusion

    Drug

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

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Continuous epidural infusion (CEI)Active comparator 2 interventions
Group B: Programmed intermittent epidural bolus (PIEB)Experimental treatment 2 interventions

Trial outcomes

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.

Time frame
72 hours after surgery

Secondary outcomes

1

Postoperative opioid consumption

Cumulative postoperative opioid consumption in morphine millequivalents.

Time frame
72 hours after surgery
2

Epidural leakage

Incidence of local anesthetic leaking from epidural.

Time frame
72 hours after surgery
3

Hypotension

Incidence of postoperative hypotension requiring intervention.

Time frame
72 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Giorgio Veneziano

Lead sponsor

Nationwide Children's Hospital

Sponsor institution

Source ClinicalTrials.gov

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