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Withdrawn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
|
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
|
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
Collaborators
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.