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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05310266
Other study ID # 2020-35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 6, 2020
Est. completion date February 21, 2022

Study information

Verified date July 2022
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Laparoscopic appendectomy causes postoperative pain. The primary objective of this prospective randomized controlled study is to compare the effect of ultrasound (US)-guided quadratus lumborum block (QLB) on 24-hour cumulative opioid requirements with transversus abdominis plane (TAP) block.


Description:

168 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo laparoscopic appendectomy, were randomized and divided into two groups. 32 patients were dropout for different reasons.(68 patients in each of the TAP block and QLB block groups). TAP block was performed for TAP group and QLB block was performed for QLB group. Postoperative analgesia was provided by intravenous tramadol hydrochloride using a patient-controlled analgesia device. 24-hour total tramadol hydrochloride consumption was primary outcome measure.Postoperative numeric rating scale values were the secondary outcome measure.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date February 21, 2022
Est. primary completion date November 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Ages of 18-65 - Patients who will undergo laparoscopic appendectomy - ASA I-II-III patients Exclusion Criteria: - Clinically known local anesthetic allergy - Morbid obesity (body mass index>40 kg m2) - Clinically diagnosis of opioid, alcohol and substance dependence - Clinically diagnosis of psychiatric disease - Coagulopathy - Patients with ASA IV-V

Study Design


Intervention

Procedure:
Transversus abdominis plane block
The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia
Quadratus Lumborum Block
The investigators performed quadratus lumborum block to that patient group for postoperative analgesia

Locations

Country Name City State
Turkey Bakirkoy Dr. Sadi Konuk Research and Training Hospital Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Baytar Ç, Yilmaz C, Karasu D, Topal S. Comparison of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled Clinical Study. Pain Res Manag. 2019 Feb — View Citation

Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double — View Citation

Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):48 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative 24-hours total tramadol hydrochloride consumption This will be measured by pca device in the 24 hour after 24 hours postoperatively
Secondary Numerical rating scale (NRS) scores of patients Numerical rating scale (NRS) at 1, 6, 12, 18, 24th hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable. 24 hours postoperatively
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