Regional Blocks of Gynecological Surgeries

Cairo University (CU)

Status

Completed

Conditions

Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia

Treatments

Procedure: 27G Dural Puncture Epidural Technique

Procedure: 25G Dural Puncture Epidural Technique

Procedure: Standard Lumbar Epidural Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT03790748

IUD2900

Details and patient eligibility

About

This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.

Enrollment

273 patients

Sex

Female

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

273 participants in 3 patient groups

Conventional Epidural Technique

Experimental group

Description:

Procedure: Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L4-5 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Treatment:

Procedure: 25G Dural Puncture Epidural Technique

Procedure: 27G Dural Puncture Epidural Technique

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

Active Comparator group

Description:

Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Treatment:

Procedure: 27G Dural Puncture Epidural Technique

Procedure: Standard Lumbar Epidural Technique

Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle

Active Comparator group