Regional Blocks of Gynecological Surgeries

NCT03790748 | Completed DMC

• 1 other identifier: IUD2900
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia

Keywords

Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease

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

Secondary Outcomes (12)

• Onset of sensory blockade

  Up to 30 minutes after local anesthetic injection

• Maximum achieved sensory level

  Up to 30 minutes after local anesthetic injection

• Time to achieve the maximum sensory level

  Up to 30 minutes after local anesthetic injection

• Onset of motor blockade

  Up to 30 minutes after local anesthetic injection

• Time to complete motor block

  Up to 30 minutes after local anesthetic injection

Study Arms (3)

Conventional Epidural Technique

EXPERIMENTAL

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.

Procedure: 25G Dural Puncture Epidural Technique; Procedure: 27G Dural Puncture Epidural Technique

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

ACTIVE COMPARATOR

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

Procedure: Standard Lumbar Epidural Technique; Procedure: 27G Dural Puncture Epidural Technique

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

ACTIVE COMPARATOR

Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Procedure: Standard Lumbar Epidural Technique; Procedure: 25G Dural Puncture Epidural Technique

Interventions

Standard Lumbar Epidural Technique PROCEDURE

Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle; Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle

25G Dural Puncture Epidural Technique PROCEDURE

25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

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

27G Dural Puncture Epidural Technique PROCEDURE

27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

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

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

Location

Reham Ali Abdelrahman

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Reham Ali Abdelrahman, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

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: Lecturer of Anesthesia

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: January 2, 2019
• Study Start: February 1, 2019
• Primary Completion: June 28, 2021
• Study Completion: July 31, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

EG (2)