CompletedPhase 4

Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia

Qatar136 participantsStarted 2024-02-21

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 50 yrs * In active labour * ASA 2 patients (pregnant patients are considered to be ASA 2) * Singleton pregnancy * \> 37 weeks gestation * Booking BMI 18 to 35 Exclusion Criteria: * BMI \< 18 * BMI \> 35 * Systemic opioids within the previous 6 hours * Presence of a fetal anomaly * Pre-eclampsia * Bleeding disorders (including coagulation disorders) * Recent spinal surgery * Spinal injury * Elevated intracranial pressure (ICP) * Neuraxial disorders of any description * Signs of local or systemic infection * Patient refusal for neuraxial analgesia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score

Timeframe: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)

Trial details

NCT IDNCT06266767

SponsorHamad Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-05

View on ClinicalTrials.gov More Labor Pain trials