Skip to main content
Clinical Trials/NCT04541719
NCT04541719
Withdrawn
Phase 2

Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study

Mansoura University1 site in 1 countryApril 1, 2017

Overview

Phase
Phase 2
Intervention
Patient-controlled remifentanil analgesia
Conditions
Labor Pain
Sponsor
Mansoura University
Locations
1
Primary Endpoint
Overall patient's satisfaction
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.

Detailed Description

We are aiming to study the effects of patient controlled remifentanil analgesia and epidural analgesia for normal labour in full term parturients on: * Peripartum analgesia * Overall patient's satisfaction * Maternal adverse effects * Neonatal outcomes

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
July 1, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed R El Tahan

Professor

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • Gestational age \> 36 weeks
  • American Society of Anesthesiologists physical class I to III

Exclusion Criteria

  • Allergy to study solution
  • Contraindications to epidural analgesia
  • Non consented parturients
  • Communications barriers.
  • Intrauterine foetal growth retardation
  • Foetal distress

Arms & Interventions

Patient-controlled remifentanil analgesia

Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery

Intervention: Patient-controlled remifentanil analgesia

Epidural analgesia

Patients will received continuous epidural analgesia starting from labour pain until delivery

Intervention: Epidural analgesia

Outcomes

Primary Outcomes

Overall patient's satisfaction

Time Frame: For 24 hours after labour

As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)

Secondary Outcomes

  • Maternal respiratory depression(For 24 hours after the start of labour pain)
  • Neonatal Apgar score at 1 min(For 5 min after birth)
  • Neonatal Apgar score at 5 min(For 5 min after birth)
  • Neonatal blood PaO2(For 5 min after birth)
  • Neonatal blood PaCO2(For 5 min after birth)
  • Neonatal blood pH(For 5 min after birth)
  • Pain Visual Analog Score at rest(For 24 hours after the start of labour pain)
  • Pain Visual Analog Score on movement(For 24 hours after the start of labour pain)
  • Maternal nausea and vomiting(For 24 hours after the start of labour pain)

Study Sites (1)

Loading locations...

Similar Trials