NCT04541719

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

September 2, 2020

Last Update Submit

September 2, 2020

Conditions

Labor PainFull Term Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Overall patient's satisfaction

    As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)

    For 24 hours after labour

Secondary Outcomes (9)

  • Pain Visual Analog Score at rest

    For 24 hours after the start of labour pain

  • Pain Visual Analog Score on movement

    For 24 hours after the start of labour pain

  • Maternal nausea and vomiting

    For 24 hours after the start of labour pain

  • Maternal respiratory depression

    For 24 hours after the start of labour pain

  • Neonatal Apgar score at 1 min

    For 5 min after birth

  • +4 more secondary outcomes

Study Arms (2)

Patient-controlled remifentanil analgesia

ACTIVE COMPARATOR

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

Drug: Patient-controlled remifentanil analgesia

Epidural analgesia

PLACEBO COMPARATOR

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

Drug: Epidural analgesia

Interventions

Patient-controlled remifentanil analgesiaDRUG

Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min

Patient-controlled remifentanil analgesia
Epidural analgesiaDRUG

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

Epidural analgesia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Nabil A Abd El Raouf, MD

    Professor in Cardiothoracic Ananesthesia

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 9, 2020

Study Start

April 1, 2017

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

EG(1)