Study Stopped
There is a duplicate study registered. The trial registration and later updates will be in NCT04933500. That is the record that will be updated.
Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedNovember 22, 2021
November 1, 2021
3 months
June 5, 2021
November 13, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Time of onset of anesthesia to T10
During surgery
Time for complete motor block
During surgery
Time for first rescue analgesia will be required during surgery
During surgery
Study Arms (2)
Group A
PLACEBO COMPARATORWomen who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural
Group B
ACTIVE COMPARATORWomen who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age (25- 55) years. Height (150 -170) cm.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Research Centre, Egyptlead
- Cairo Universitycollaborator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2021
First Posted
June 10, 2021
Study Start
July 1, 2021
Primary Completion
October 1, 2021
Study Completion
November 1, 2021
Last Updated
November 22, 2021
Record last verified: 2021-11