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Patient Controlled Remifentanil Analgesia for Normal Labour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541719
Recruitment Status : Withdrawn (no participants enrolled)
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
Cairo University
Alexandria University
Information provided by (Responsible Party):
Mohamed R El Tahan, 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.

Condition or disease Intervention/treatment Phase
Labor Pain Full Term Pregnancy Drug: Patient-controlled remifentanil analgesia Drug: Epidural analgesia Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patient-controlled remifentanil analgesia
Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery
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

Placebo Comparator: Epidural analgesia
Patients will received continuous epidural analgesia starting from labour pain until delivery
Drug: 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. Maternal respiratory depression [ Time Frame: For 24 hours after the start of labour pain ]
    If respiratory rate decreases less than 10/min

  5. Neonatal Apgar score at 1 min [ Time Frame: For 5 min after birth ]
    Assessed using 5-points Apgar score

  6. Neonatal Apgar score at 5 min [ Time Frame: For 5 min after birth ]
    Assessed using 5-points Apgar score

  7. Neonatal blood PaO2 [ Time Frame: For 5 min after birth ]
    PaO2 value

  8. Neonatal blood PaCO2 [ Time Frame: For 5 min after birth ]
    PaCO2 value

  9. Neonatal blood pH [ Time Frame: For 5 min after birth ]
    pH value



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541719


Locations
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Egypt
Mansoura University Hospitals
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Cairo University
Alexandria University
Investigators
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Study Chair: Nabil A Abd El Raouf, MD Professor in Cardiothoracic Ananesthesia
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Responsible Party: Mohamed R El Tahan, Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT04541719    
Other Study ID Numbers: MFM-XYZ-2017
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents