NCT05031117

Brief Summary

25G Dural Puncture Epidural Technique will be compared with Conventional Standard Lumbar Epidural Technique During Anesthesia of Laparoscopic Assisted Vaginal Hysterectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

August 28, 2021

Last Update Submit

August 30, 2023

Conditions

Gynecologic Diseases Requiring Vaginal Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • incidence of bilateral sacral blockade

    Up to 30 minutes after local anesthetic injection

Study Arms (2)

Conventional Epidural Technique

EXPERIMENTAL
Procedure: 25G Dural Puncture Epidural Technique

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle

ACTIVE COMPARATOR
Procedure: Conventional Epidural Technique

Interventions

Conventional Epidural TechniquePROCEDURE

Standard Lumbar Epidural Technique at L4-5 interspace using Tuhoy needle (18G) then epidural catheter (20G) inserted, then 15ml 0.5% Bupivacane and 50ug fentanyl given.

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle
25G Dural Puncture Epidural TechniquePROCEDURE

25G pencil point spinal needle will be inserted at L4-5 interspace through the tuhoy needle

Conventional Epidural Technique

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 25-55 years old.
  • Height: 165 cm.

You may not qualify if:

  • Patient Refusal.
  • Coagulopathy.
  • Deformity of lumbar vertebrae.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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 28, 2021

First Posted

September 1, 2021

Study Start

January 10, 2022

Primary Completion

December 30, 2022

Study Completion

February 19, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

EG(1)