Dural Puncture Epidural Technique Versus Conventional Epidural Techmique

Comparative Study Between Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Laparoscopic Hysterectomy

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia
• Intervention / Treatment: Procedure: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle; Procedure: Conventional Epidural Technique

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Department of Anesthesia, Surgical ICU, and Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I and II
• Height(150-170 cm)

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional Epidural Technique	Procedure: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle; 25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Active Comparator: Dural Puncture Epidural technique using pencil-point 25G Whitacre needle	Procedure: Conventional Epidural Technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Reham Ali Abdelrahman, M.D., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ES-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No