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PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Nov 2026
    • Study completion date: Mar 2026 to Dec 2026
    v6
  2. Primary completion date: Jul 2025 to Dec 2025
    • Study completion date: Aug 2025 to Mar 2026
    • Start date changed from estimate of Sep 2024 to Sep 10, 2024
    v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2024 to Sep 2024
    • Site details revised
    v4
  4. Start date: Jul 2024 to Aug 2024
    • Site contact updated
    v3
  5. Secondary endpoints: details revised at 1 of 26 entriesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in nulliparous women compared to continuous epidural infusion. Nulliparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.
Trial Details
NCT Number NCT06494280
Lead Sponsor Holy Family Hospital, Nazareth, Israel
Conditions
(from sponsor)		 Breakthrough Pain
Related terms Breakthrough Pain
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov