Transversus Abdominis Plane Block Versus Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy
The Comparison of Ultrasound-Guided Transversus Abdominis Plane Block and Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy. A Randomized Controlled Trial
1 other identifier
interventional
102
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2021
CompletedJune 8, 2021
June 1, 2021
1.6 years
May 29, 2019
June 5, 2021
Conditions
Keywords
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 COMPARATORAfter 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.
Transversus Abdominis Plane Block
ACTIVE COMPARATORAfter 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.
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.
Eligibility Criteria
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)
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: 28154824BACKGROUNDBlanco 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: 27755488BACKGROUNDOksuz 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: 28759502BACKGROUNDMutlu 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.
PMID: 37429376DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ozgecan P Zanbak, MD
Istanbul University - Cerrahpasa
- STUDY CHAIR
Ayse C Tutuncu, MD,Prof
Istanbul University - Cerrahpasa
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