Dural Puncture Epidural Technique Versus Conventional Epidural Techmique
Comparative Study Between Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Laparoscopic Hysterectomy
1 other identifier
interventional
50
1 country
1
Brief Summary
This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
1 active site
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
Study Start
First participant enrolled
August 18, 2021
CompletedFirst Submitted
Initial submission to the registry
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2022
CompletedDecember 15, 2022
December 1, 2022
1.2 years
August 27, 2021
December 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of bilateral sacral blockade
Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes)
Up to 30 minutes after local anesthetic injection
Study Arms (2)
Conventional Epidural Technique
EXPERIMENTALDural Puncture Epidural technique using pencil-point 25G Whitacre needle
ACTIVE COMPARATORInterventions
Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L2-3 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Eligibility Criteria
You may qualify if:
- ASA I and II
- Height(150-170 cm)
You may not qualify if:
- patient refusal
- hypersensitivity to local anesthetic drugs
- bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Reham Ali Abdelrahman, M.D.
Cairo University
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesia lecturer M.D.
Study Record Dates
First Submitted
August 27, 2021
First Posted
September 2, 2021
Study Start
August 18, 2021
Primary Completion
November 2, 2022
Study Completion
December 10, 2022
Last Updated
December 15, 2022
Record last verified: 2022-12