Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Mansoura University
- Locations
- 1
- Primary Endpoint
- Overall patient's satisfaction
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 (Drug)
Epidural analgesia
Patients will received continuous epidural analgesia starting from labour pain until delivery
Intervention: Epidural analgesia (Drug)
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)
Investigators
Mohamed R El Tahan
Professor
Mansoura University