Regional Blocks of Gynecological Surgeries

Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia
• Intervention / Treatment: Procedure: 25G Dural Puncture Epidural Technique; Procedure: 27G Dural Puncture Epidural Technique; Procedure: Standard Lumbar Epidural Technique

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional Epidural Technique; 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; 25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.; Procedure: 27G Dural Puncture Epidural Technique; 27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Active Comparator: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle; Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.	Procedure: 27G Dural Puncture Epidural Technique; 27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.; Procedure: Standard Lumbar Epidural Technique; Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Active Comparator: Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle; Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.	Procedure: 25G Dural Puncture Epidural Technique; 25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.; Procedure: Standard Lumbar Epidural Technique; Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of sensory block	Time to two segmental dermatomes regression	Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia
Duration of motor block	Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1	Assessed every 20 minutes after achieving Bromage 3 motor block
Duration of analgesia	Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished	Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively
Number of epidural top-ups		Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery
Sedation score		Assessed every 20 minutes during the surgical procedure and postoperatively
Hemodynamic parameters		Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms
Perioperative side effects		During surgical period up to 7 days post-operatively

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): February 1, 2019
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: December 23, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease
• Other Study ID Numbers: IUD2900

Drug and device information, study documents

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