Completed

NCT Number: NCT05032677

Dural Puncture Epidural Technique Versus Conventional Epidural Techmique

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.

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Key information

Conditions

Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Conventional Epidural Technique

Procedure

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.

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

Procedure

25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Primary outcomes

incidence of bilateral sacral blockade

Time frame: Up to 30 minutes after local anesthetic injection

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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 2, 2021
Registry last updated: Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.