NCT05310266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

March 26, 2022

Last Update Submit

July 25, 2022

Conditions

Post Operative PainAppendicitis AcuteSurgery

Keywords

Postoperative painLaparoscopic appendectomyTransversus abdominis plane blockQuadratus Lumborum BlockLocal anesthetic

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24-hours total tramadol hydrochloride consumption

    This will be measured by pca device in the 24 hour after

    24 hours postoperatively

Secondary Outcomes (1)

  • Numerical rating scale (NRS) scores of patients

    24 hours postoperatively

Study Arms (2)

Group TAP

ACTIVE COMPARATOR

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

Procedure: Transversus abdominis plane block

Group QLB

ACTIVE COMPARATOR

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

Procedure: Quadratus Lumborum Block

Interventions

Transversus abdominis plane blockPROCEDURE

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

Group TAP
Quadratus Lumborum BlockPROCEDURE

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

Group QLB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages of 18-65
  • Patients who will undergo laparoscopic appendectomy
  • ASA I-II-III patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27056207RESULT

  • 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.

    PMID: 30863471RESULT

  • 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.

    PMID: 33762197RESULT

MeSH Terms

Conditions

Pain, PostoperativeAppendicitis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 4, 2022

Study Start

April 6, 2020

Primary Completion

November 17, 2021

Study Completion

February 21, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
One year within the publication date.

Locations

TU(1)