Patient Controlled Remifentanil Analgesia for Normal Labour

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04541719
• Other study ID #: MFM-XYZ-2017
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Full Term Pregnancy
• Labor Pain

Intervention

Drug:
• Patient-controlled remifentanil analgesia
Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 µg remifentanil with a lockout interval of 2 min
• Epidural analgesia
Patients will receive continuous epidural analgesia using bupivacaine 0.125% in conjunction with fentanyl 2 ug/ml at a rate of 8-15 ml/hr

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	DK

Sponsors (3)

Lead Sponsor	Collaborator
Mansoura University	Alexandria University, Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall patient's satisfaction	As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)	For 24 hours after labour
Secondary	Pain Visual Analog Score at rest	As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)	For 24 hours after the start of labour pain
Secondary	Pain Visual Analog Score on movement	As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)	For 24 hours after the start of labour pain
Secondary	Maternal nausea and vomiting	(0: no nausea or vomiting, 1: severe nausea, 3: vomiting)	For 24 hours after the start of labour pain
Secondary	Maternal respiratory depression	If respiratory rate decreases less than 10/min	For 24 hours after the start of labour pain
Secondary	Neonatal Apgar score at 1 min	Assessed using 5-points Apgar score	For 5 min after birth
Secondary	Neonatal Apgar score at 5 min	Assessed using 5-points Apgar score	For 5 min after birth
Secondary	Neonatal blood PaO2	PaO2 value	For 5 min after birth
Secondary	Neonatal blood PaCO2	PaCO2 value	For 5 min after birth
Secondary	Neonatal blood pH	pH value	For 5 min after birth