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

Primary Purpose

Uterine Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

erector spinae plane block

transversus abdominis plane block

About this trial

This is an interventional treatment trial for Uterine Diseases focused on measuring ESPB, TAP

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A : erector spinae block.

Group B : transversus abdominis plane block.

Arm Description

patients will receive bilateral ultrasound guided erector spinae block.

patients will receive bilateral ultrasound guided transversus abdominis plane block.

Outcomes

Primary Outcome Measures

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

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).

The time for first call rescue analgesia

the time for first call rescue analgesia

Secondary Outcome Measures

Patient satisfaction

Measure patient satisfaction by asking the patient if he is satisfied or not "yes or no"

Recognize the adverse effects

Full Information

NCT ID

NCT05533710

First Posted

September 3, 2022

Last Updated

September 7, 2022

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05533710

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 28, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Diseases

Keywords

ESPB, TAP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A : erector spinae block.

Arm Type

Experimental

Arm Description

patients will receive bilateral ultrasound guided erector spinae block.

Arm Title

Group B : transversus abdominis plane block.

Arm Type

Experimental

Arm Description

patients will receive bilateral ultrasound guided transversus abdominis plane block.

Intervention Type

Procedure

Intervention Name(s)

erector spinae plane block

Intervention Description

Patients will receive ESB. In the lateral decubitus, after skin sterilization, ESP block will be performed at the level of T9

Intervention Type

Procedure

Intervention Name(s)

transversus abdominis plane block

Intervention Description

patients will receive TAP block in supine position after skin sterilization, TAP block will be performed between internal oblique and transversus abdominis muscles

Primary Outcome Measure Information:

Title

Total morphine consumption

Description

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

Time Frame

24 hours postoperative

Title

Visual Analog Scale Score

Description

Time Frame

24 hours postoperative

Title

The time for first call rescue analgesia

Description

the time for first call rescue analgesia

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

Patient satisfaction

Description

Measure patient satisfaction by asking the patient if he is satisfied or not "yes or no"

Time Frame

24 hours postoperative

Title

Recognize the adverse effects

Description

Recognize the adverse effects

Time Frame

24 hours postoperative

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients American Society of Anesthesiologists physical status (ASA) I and II. Female sex. Age between 40 to 60 years old. Scheduled for elective total abdominal hysterectomy surgeries. Exclusion Criteria: Patient's refusal. Patients who received long-acting opioids preoperatively. Patients with bleeding disorders and coagulopathy. Infection at the injection site. Allergy to local anesthetics. Patients with significant cognitive dysfunction. Patients with diabetic neuropathy. Patients with uncontrolled hypertension or diabetes. Patients with advanced cardiac, respiratory, hepatic or renal disease. Patients with viral hepatitis or HIV. Surgeries which have been complicated or prolonged (more than 150 mins).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

israa ihab, MSc

Phone

01005461696

Ext

israa_ihab@med.asu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ossama mansour, professor

Organizational Affiliation

Ain Shams University

Official's Role

Study Chair

Facility Information:

Facility Name

Ain Shams University

City

Cairo

ZIP/Postal Code

11591

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

israa ihab, MSc

Phone

01005461696

Ext

israa_ihab@med.asu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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