Patient Controlled Remifentanil Analgesia for Normal Labour
September 2, 2020 updated by: Mohamed R El Tahan, Mansoura University
Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study
Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DK
-
Mansoura, DK, Egypt, 050
- Mansoura University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Patient-controlled remifentanil analgesia
Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery
|
Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min
|
|
PLACEBO_COMPARATOR: Epidural analgesia
Patients will received continuous epidural analgesia starting from labour pain until delivery
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
For 24 hours after labour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Visual Analog Score at rest
Time Frame: 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)
|
For 24 hours after the start of labour pain
|
|
Pain Visual Analog Score on movement
Time Frame: 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)
|
For 24 hours after the start of labour pain
|
|
Maternal nausea and vomiting
Time Frame: For 24 hours after the start of labour pain
|
(0: no nausea or vomiting, 1: severe nausea, 3: vomiting)
|
For 24 hours after the start of labour pain
|
|
Maternal respiratory depression
Time Frame: For 24 hours after the start of labour pain
|
If respiratory rate decreases less than 10/min
|
For 24 hours after the start of labour pain
|
|
Neonatal Apgar score at 1 min
Time Frame: For 5 min after birth
|
Assessed using 5-points Apgar score
|
For 5 min after birth
|
|
Neonatal Apgar score at 5 min
Time Frame: For 5 min after birth
|
Assessed using 5-points Apgar score
|
For 5 min after birth
|
|
Neonatal blood PaO2
Time Frame: For 5 min after birth
|
PaO2 value
|
For 5 min after birth
|
|
Neonatal blood PaCO2
Time Frame: For 5 min after birth
|
PaCO2 value
|
For 5 min after birth
|
|
Neonatal blood pH
Time Frame: For 5 min after birth
|
pH value
|
For 5 min after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nabil A Abd El Raouf, MD, Professor in Cardiothoracic Ananesthesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2017
Primary Completion (ACTUAL)
May 1, 2018
Study Completion (ACTUAL)
July 1, 2018
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
September 2, 2020
First Posted (ACTUAL)
September 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MFM-XYZ-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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