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Comparison of Regimens MPIB, CIPCEA, PCEA

Study acronym: COLEUS
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study completion pushed from Dec 31, 2026 to Dec 31, 2027v17
  2. Study completion date: Dec 31, 2025 to Dec 31, 2026v16
  3. Study completion date: Dec 31, 2023 to Dec 31, 2025v15
  4. Study completion date: Dec 31, 2022 to Dec 31, 2023v14
  5. Study completion date: Dec 30, 2021 to Dec 31, 2022
    • Study description expanded, about 29 words
    • Study title revised
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study completion date: Nov 30, 2020 to Dec 30, 2021v12
  2. Secondary endpoints: 7 to 8v11
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 31, 2019 to May 6, 2019
    • Study completion date: Mar 31, 2020 to Nov 30, 2020
    • Site details revised
    v10
  4. Secondary endpoints: 5 to 7v9
  5. Enrollment target: 3412 to 839
    • Secondary endpoints: 3 to 5
    • Study description expanded, about 48 words
    v8
  6. Primary completion date: May 31, 2019 to Dec 31, 2019
    • Study completion date: Dec 30, 2019 to Mar 31, 2020
    v7
  7. Primary completion date: Nov 2018 to May 31, 2019
    • Study completion date: Nov 2018 to Dec 30, 2019
    • Start date: Jan 2015 to Jan 28, 2015
    v6
  8. Primary and study completion dates: Apr 2018 to Nov 2018v5
  9. Primary and study completion dates: Dec 2017 to Apr 2018
    • Interventions: epidural delivery system (Device) to Fentanyl (Drug), Ropivacaine (Drug), epidural delivery system (Device)
    • Site details revised
    v4
  10. Re-verified, no change to tracked fieldsv3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2014 to Jan 2015
    • Study sites: 0 to 1
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more than 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. Women who have increased pain tend to have lower successful patient bolus demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour pain often escalates and worsens as labour progresses requiring an individualized, variable, flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform spread of local anaesthetics with better pain relief, compared to fixed background infusions.
Trial Details
NCT Number NCT02278601
Lead Sponsor KK Women's and Children's Hospital
Conditions
(from sponsor)		 Breakthrough Pain
Related terms Breakthrough Pain
Enrollment 839 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov