Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pain Management in Laparoscopic Appendectomy

July 25, 2022 updated by: Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Ultrasound-guided Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Appendectomy: A Prospective, Randomized, Controlled Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakirkoy
      • Istanbul, Bakirkoy, Turkey, 34147
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group TAP
The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia
Procedure: Transversus abdominis plane block
The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia
ACTIVE_COMPARATOR: Group QLB
The investigators performed quadratus lumborum block to that patient group for postoperative analgesia
Procedure: Quadratus Lumborum Block
The investigators performed quadratus lumborum block to that patient group for postoperative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative 24-hours total tramadol hydrochloride consumption
Time Frame: 24 hours postoperatively
This will be measured by pca device in the 24 hour after
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale (NRS) scores of patients
Time Frame: 24 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 6, 2020

Primary Completion (ACTUAL)

November 17, 2021

Study Completion (ACTUAL)

February 21, 2022

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

March 26, 2022

First Posted (ACTUAL)

April 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data available from the publication date can start. NRS scores will be shared. If requested, data will be shared with anesthesiologists dealing with postoperative pain management.

IPD Sharing Time Frame

One year within the publication date.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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