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

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.

Eligibility

Age range

Up to 18 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Ropivacaine (Epidural analgesia) intermittent bolus

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

• Drug
  Ropivacaine (Epidural analgesia) continuous infusion

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

• Drug
  Chloroprocaine intermittent bolus

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

• Drug
  Chloroprocaine continuous infusion

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

Location