drugset / Trial / NCT06266767

Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia

NCT06266767

Phase 4 Completed 136 enrolled Hamad Medical Corporation
RandomizedSequentialTriple-blindHealth-services research

Summary

Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score.

Timeline

Start
2024-02-21
Primary completion
2024-10-05
Completion
2024-10-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 2 ug/ml Other
Subject Levobupivacaine Other / unclassified 0.1 % Other