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

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05310266

Collaborator

(none)

168

Enrollment

Location

Arms

22.5

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Appendicitis Acute Surgery	Procedure: Transversus abdominis plane block Procedure: Quadratus Lumborum Block	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 6, 2020

Actual Primary Completion Date :

Nov 17, 2021

Actual Study Completion Date :

Feb 21, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postoperative 24-hours total tramadol hydrochloride consumption [24 hours postoperatively]
This will be measured by pca device in the 24 hour after

Secondary Outcome Measures

Numerical rating scale (NRS) scores of patients [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Istanbul	Bakirkoy	Turkey	34147

Sponsors and Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gokhan Sertcakacilar, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

ClinicalTrials.gov Identifier:

NCT05310266

Other Study ID Numbers:

2020-35

First Posted:

Apr 4, 2022

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gokhan Sertcakacilar, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Postoperative pain

Laparoscopic appendectomy

Transversus abdominis plane block

Quadratus Lumborum Block

Local anesthetic

Additional relevant MeSH terms:

Appendicitis

Pain, Postoperative

Study Results

No Results Posted as of Jul 27, 2022