Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery

March 4, 2020 updated by: Staikou Chryssoula, University of Athens

The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study

The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

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 Contact

  • Name: Chyrssoula Staikou, Assoc Prof
  • Phone Number: 00302107780172
  • Email: c_staikou@yahoo.gr

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Aretaieio Hospital
        • Contact:
          • Chryssoula V Staikou, Assoc Prof
    • Attiki
      • Athens, Attiki, Greece, 11528
        • Recruiting
        • Aretaieio Hospital, University of Athens

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:

  • parturients requiring regional labor analgesia
  • dilation less than 5cm

Exclusion Criteria:

  • contraindication for regional technique
  • refuse to participate
  • language barriers
  • obesity
  • no pain

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: epidural
Procedure: regional analgesia for labor
three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
ACTIVE_COMPARATOR: combined
Procedure: regional analgesia for labor
three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
ACTIVE_COMPARATOR: dural puncture epidural
Procedure: regional analgesia for labor
three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic consumption
Time Frame: during the procedure/delivery
the amount of local anesthetic and opioid that required during labor
during the procedure/delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity on a numerical rating scale (minimum=0, maximum=10)
Time Frame: during the procedure/delivery
pain intensity
during the procedure/delivery
duration of labor
Time Frame: until delivery
duration of first stage
until delivery
satisfaction on a numerical rating scale (minimum=0, maximum=10)
Time Frame: during the procedure/delivery
satisfaction of parturients
during the procedure/delivery

Collaborators and Investigators

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

Sponsor

University of Athens

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)

February 26, 2020

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (ACTUAL)

March 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 155/19-12-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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