NCT03969316

Brief Summary

Transversus abdominis plane (TAP) and Quadratus lumborum (QL) blocks are used for the management of acute pain treatment, especially after the lower and upper abdominal surgeries. The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia. The investigators' aim in this study, to investigate the effect of the TAP and QL blocks on peroperative and postoperative analgesic consumption in children undergoing unilateral elective orchiopexy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

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

May 10, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

May 29, 2019

Last Update Submit

June 5, 2021

Conditions

Keywords

quadratus lumborum blocktransversus abdominis plane blockpediatric patientorchiopexyregional anesthesiapain

Outcome Measures

Primary Outcomes (3)

  • Total Analgesia Consumption

    The required analgesic consumption within the framework of the predetermined protocol will be recorded by the nurses and doctors who do not know which block is used. After discharge, the family will be called by phone to find out the amount of additional analgesic need.

    24 hour

  • The Effect on Perioperative and Postoperative Pain

    The investigator will screen and record perioperative hemodynamic parameters for the perioperative pain evaluation. The Face, Legs, Activity, Cry, Consobility (FLACC) Score will be used for evaluation of the postoperative pain. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned.

    24 hour

  • The Effect on Post-discharge Pain

    Post-discharge pain will be assessed by the Wong Baker Score. Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.

    24 hour

Secondary Outcomes (1)

  • Parent satisfaction score

    24 hour

Study Arms (2)

Quadratus Lumborum Block

ACTIVE COMPARATOR

After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the anterolateral border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.

Procedure: Transversus abdominis plane block, Quadratus lumborum block

Transversus Abdominis Plane Block

ACTIVE COMPARATOR

After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound between internal oblique and transversus abdominis muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.

Procedure: Transversus abdominis plane block, Quadratus lumborum block

Interventions

The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.

Quadratus Lumborum BlockTransversus Abdominis Plane Block

Eligibility Criteria

Age6 Months - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status I-III
  • Undergoing elective unilateral orchiopexy

You may not qualify if:

  • Not giving a consent
  • ASA physical status IV
  • Need to postoperative ICU care
  • History of allergic reactions to anesthetics
  • Infection at the injection site
  • Laparoscopic Orchiopexy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, 34100, Turkey (Türkiye)

Location

Related Publications (4)

  • Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.

    PMID: 28154824BACKGROUND
  • Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

    PMID: 27755488BACKGROUND
  • Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.

    PMID: 28759502BACKGROUND
  • Mutlu OPZ, Tutuncu AC, Kendigelen P, Kara Esen B. Posterior transversus abdominis plane block versus lateral quadratus lumborum block in children undergoing open orchiopexy: a randomized clinical trial☆. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744443. doi: 10.1016/j.bjane.2023.06.004. Epub 2023 Jul 8.

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ozgecan P Zanbak, MD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Ayse C Tutuncu, MD,Prof

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Medical Doctor, Anesthesiology and Reanimation Department

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

May 10, 2019

Primary Completion

December 18, 2020

Study Completion

March 13, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations