Patient Controlled Remifentanil Analgesia for Normal Labour

Phase 2

Withdrawn

• Conditions: Labor Pain; Full Term Pregnancy
• Interventions: Drug: Epidural analgesia; Drug: Patient-controlled remifentanil analgesia

• Registration Number: NCT04541719
• Lead Sponsor: Mansoura University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-07-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural analgesia	Epidural analgesia	Patients will received continuous epidural analgesia starting from labour pain until delivery
Patient-controlled remifentanil analgesia	Patient-controlled remifentanil analgesia	Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery

Primary Outcome Measures

Name	Time	Method
Overall patient's satisfaction	For 24 hours after labour	As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)

Secondary Outcome Measures

Name	Time	Method
Maternal respiratory depression	For 24 hours after the start of labour pain	If respiratory rate decreases less than 10/min
Neonatal Apgar score at 1 min	For 5 min after birth	Assessed using 5-points Apgar score
Neonatal Apgar score at 5 min	For 5 min after birth	Assessed using 5-points Apgar score
Neonatal blood PaO2	For 5 min after birth	PaO2 value
Neonatal blood PaCO2	For 5 min after birth	PaCO2 value
Neonatal blood pH	For 5 min after birth	pH value
Pain Visual Analog Score on movement	For 24 hours after the start of labour pain	As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)
Maternal nausea and vomiting	For 24 hours after the start of labour pain	(0: no nausea or vomiting, 1: severe nausea, 3: vomiting)
Pain Visual Analog Score at rest	For 24 hours after the start of labour pain	As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansoura, DK, Egypt