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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05533710
Other study ID # ainshamsU FAMSU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 28, 2021
Est. completion date August 2023

Study information

Verified date September 2022
Source Ain Shams University
Contact israa ihab, MSc
Phone 01005461696
Email israa_ihab@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary The time for first call rescue analgesia the time for first call rescue analgesia 24 hours postoperative
Secondary Patient satisfaction Measure patient satisfaction by asking the patient if he is satisfied or not "yes or no" 24 hours postoperative
Secondary Recognize the adverse effects Recognize the adverse effects 24 hours postoperative
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