Comparison Between Erector Spinae Plane Block and Transversus Abdominis Plane Block on Postoperative Analgesia After Total Abdominal Hysterectomy

Comparative Study Between Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Bilateral Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Analgesia After Total Abdominal Hysterectomy

This study aims to compare the ultrasound-guided bilateral erector spinae block versus the ultrasound-guided bilateral transversus abdominis plane block on postoperative analgesia after total abdominal hysterectomy.

Study Overview

• Status: Recruiting
• Conditions: Uterine Diseases
• Intervention / Treatment: Procedure: erector spinae plane block; Procedure: transversus abdominis plane block

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: israa ihab, MSc; Phone Number: +2 01005461696; Email: israa_ihab@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain shams university
    • Contact: israa ihab, MSc; Phone Number: +2 01005461696; Email: israa_ihab@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patients American Society of Anesthesiologists physical status (ASA) I and II.
2. Female sex.
3. Age between 40 to 60 years old.
4. Scheduled for elective total abdominal hysterectomy surgeries.

Exclusion Criteria:

1. Patient's refusal.
2. Patients who received long-acting opioids preoperatively.
3. Patients with bleeding disorders and coagulopathy.
4. Infection at the injection site.
5. Allergy to local anesthetics.
6. Patients with significant cognitive dysfunction.
7. Patients with diabetic neuropathy.
8. Patients with uncontrolled hypertension or diabetes.
9. Patients with advanced cardiac, respiratory, hepatic or renal disease.
10. Patients with viral hepatitis or HIV.
11. Surgeries which have been complicated or prolonged (more than 150 mins).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A : erector spinae block.; patients will receive bilateral ultrasound guided erector spinae block.	Procedure: erector spinae plane block; Patients will receive ESB. In the lateral decubitus, after skin sterilization, ESP block will be performed at the level of T9
Experimental: Group B : transversus abdominis plane block.; patients will receive bilateral ultrasound guided transversus abdominis plane block.	Procedure: transversus abdominis plane block; patients will receive TAP block in supine position after skin sterilization, TAP block will be performed between internal oblique and transversus abdominis muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Compare postoperative pain intensity using the total amount of morphine consumption in the first 24 hours after the operation, and the time for first call rescue analgesia	24 hours postoperative
Visual Analog Scale Score	Compare postoperative pain intensity using VAS score in the first 24 hours after the operation.The VAS score is a 10-cm line labeled with "worst pain imaginable" on the right border, and "no pain" on the left border (ranging from 0 by indicating no pain to 10 indicating extreme pain).	24 hours postoperative
The time for first call rescue analgesia	the time for first call rescue analgesia	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Measure patient satisfaction by asking the patient if he is satisfied or not "yes or no"	24 hours postoperative
Recognize the adverse effects	Recognize the adverse effects	24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: ossama mansour, professor, Ain shams university

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: ESPB, TAP
• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: ainshamsU FAMSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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