Neuroaxial Labour Analgesia

March 20, 2020 updated by: Wahba bakhet

A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.

The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

The secondary objective of this study is to compare the and fetomaternal outcomes

Study Overview

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

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

    • Abbasyia
      • Cairo, Abbasyia, Egypt, 002
        • Ain Shams University
    • Abbasyia
      • Kuwait, Abbasyia, Kuwait, 002
        • Elite Hospital

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Nulliparous parturient
  2. Singleton, vertex gestation at term (37-42 weeks)
  3. Less than 5 cm dilation
  4. request an epidural technique for labor analgesia

Exclusion Criteria:

  1. Hypersensitivity to local the study drugs
  2. Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
  3. Any contraindication to the administration of an epidural technique
  4. Risk factor for cesarean delivery.
  5. fetal anomalies

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: combined spinal epidural group
Bupivacaine 2.5 mg
three labor analgesia techniques
Active Comparator: dura puncture epidural group
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
three labor analgesia techniques
Active Comparator: epidural
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
three labor analgesia techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
epidural Local anesthetic consumption
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal hypotension
Time Frame: 1 year
maternal mean arterial blood pressure less than 50 mmhg
1 year
incidence of fetal bradycardia
Time Frame: 1 year
a fetal heart rate of less than 100 beats per minute
1 year
incidence of maternal pruritus
Time Frame: 1 year
Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe
1 year
labour pain scores
Time Frame: 1 year
Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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