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Comparison of Regimens MPIB, CIPCEA, PCEA

NCT02278601 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 839

Last updated 2024-10-09

No results posted yet for this study

Summary

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.

Conditions

  • Breakthrough Pain

Interventions

DEVICE

epidural delivery system

epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution

DRUG

Ropivacaine

epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution

DRUG

Fentanyl

epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Ban L Sng, FANZCA · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-28
Primary Completion
2019-05-06
Completion
2026-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02278601 on ClinicalTrials.gov