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

Primary Purpose

Post Operative Pain, Appendicitis Acute, Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus abdominis plane block
Quadratus Lumborum Block
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain focused on measuring Postoperative pain, Laparoscopic appendectomy, Transversus abdominis plane block, Quadratus Lumborum Block, Local anesthetic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group TAP

Group QLB

Arm Description

The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia

The investigators performed quadratus lumborum block to that patient group for postoperative analgesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 26, 2022
Last Updated
July 25, 2022
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05310266
Brief Title
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pain Management in Laparoscopic Appendectomy
Official Title
Ultrasound-guided Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Appendectomy: A Prospective, Randomized, Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
February 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Appendicitis Acute, Surgery
Keywords
Postoperative pain, Laparoscopic appendectomy, Transversus abdominis plane block, Quadratus Lumborum Block, Local anesthetic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group TAP
Arm Type
Active Comparator
Arm Description
The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia
Arm Title
Group QLB
Arm Type
Active Comparator
Arm Description
The investigators performed quadratus lumborum block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block
Intervention Description
The investigators performed quadratus lumborum block to that patient group for postoperative analgesia
Primary Outcome Measure Information:
Title
Postoperative 24-hours total tramadol hydrochloride consumption
Description
This will be measured by pca device in the 24 hour after
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Numerical rating scale (NRS) scores of patients
Description
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.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
27056207
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):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8.
Results Reference
result
PubMed Identifier
30863471
Citation
Baytar C, 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 3;2019:2815301. doi: 10.1155/2019/2815301. eCollection 2019.
Results Reference
result
PubMed Identifier
33762197
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-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.
Results Reference
result

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

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