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Patient Controlled Remifentanil Analgesia for Normal Labour

Primary Purpose

Labor Pain, Full Term Pregnancy

Status
Withdrawn
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Patient-controlled remifentanil analgesia
Epidural analgesia
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Labor Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patient-controlled remifentanil analgesia

Epidural analgesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall patient's satisfaction
As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2020
Last Updated
September 2, 2020
Sponsor
Mansoura University
Collaborators
Cairo University, Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04541719
Brief Title
Patient Controlled Remifentanil Analgesia for Normal Labour
Official Title
Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
Cairo University, Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Full Term Pregnancy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-controlled remifentanil analgesia
Arm Type
Active Comparator
Arm Description
Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery
Arm Title
Epidural analgesia
Arm Type
Placebo Comparator
Arm Description
Patients will received continuous epidural analgesia starting from labour pain until delivery
Intervention Type
Drug
Intervention Name(s)
Patient-controlled remifentanil analgesia
Intervention Description
Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min
Intervention Type
Drug
Intervention Name(s)
Epidural analgesia
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall patient's satisfaction
Description
As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)
Time Frame
For 24 hours after labour
Secondary Outcome Measure Information:
Title
Pain Visual Analog Score at rest
Description
As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)
Time Frame
For 24 hours after the start of labour pain
Title
Pain Visual Analog Score on movement
Description
As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)
Time Frame
For 24 hours after the start of labour pain
Title
Maternal nausea and vomiting
Description
(0: no nausea or vomiting, 1: severe nausea, 3: vomiting)
Time Frame
For 24 hours after the start of labour pain
Title
Maternal respiratory depression
Description
If respiratory rate decreases less than 10/min
Time Frame
For 24 hours after the start of labour pain
Title
Neonatal Apgar score at 1 min
Description
Assessed using 5-points Apgar score
Time Frame
For 5 min after birth
Title
Neonatal Apgar score at 5 min
Description
Assessed using 5-points Apgar score
Time Frame
For 5 min after birth
Title
Neonatal blood PaO2
Description
PaO2 value
Time Frame
For 5 min after birth
Title
Neonatal blood PaCO2
Description
PaCO2 value
Time Frame
For 5 min after birth
Title
Neonatal blood pH
Description
pH value
Time Frame
For 5 min after birth

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil A Abd El Raouf, MD
Organizational Affiliation
Professor in Cardiothoracic Ananesthesia
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Patient Controlled Remifentanil Analgesia for Normal Labour

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