Patient Controlled Remifentanil Analgesia for Normal Labour

NCT ID: NCT04541719

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain Full Term Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient-controlled remifentanil analgesia

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

Group Type ACTIVE_COMPARATOR

Patient-controlled remifentanil analgesia

Intervention Type DRUG

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 received continuous epidural analgesia starting from labour pain until delivery

Group Type PLACEBO_COMPARATOR

Epidural analgesia

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role collaborator

Alexandria University

OTHER

Sponsor Role collaborator

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed R El Tahan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nabil A Abd El Raouf, MD

Role: STUDY_CHAIR

Professor in Cardiothoracic Ananesthesia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University Hospitals

Al Mansurah, DK, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MFM-XYZ-2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.