Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries

November 13, 2021 updated by: National Research Centre, Egypt
The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Age (25- 55) years. Height (150 -170) cm.

Exclusion Criteria:

Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A
Women who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural
Procedure: Conventional epidural
In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.
Active Comparator: Group B
Women who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural
Procedure: Dural puncture epidural
In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of onset of anesthesia to T10
Time Frame: During surgery
During surgery
Time for complete motor block
Time Frame: During surgery
During surgery
Time for first rescue analgesia will be required during surgery
Time Frame: During surgery
During surgery

Collaborators and Investigators

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

Sponsor

National Research Centre, Egypt

Collaborators

Cairo University

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)

July 1, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

June 5, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dural Puncture

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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