Comparing Analgesic Effects of Three Ultrasound Guided Regional Anesthetic Techniques in Pediatrics

A Prospective Randomized Trial Comparing Analgesic Effects of Three Ultrasound-guided Regionel Anesthetic Techniques in Pediatrics: Caudal Analgesia, Transversus Abdominis Plane and Quadratus Lumborum Blocks

This study evaluates analgesic effects of ultrasound-guided (USG) regional anesthetic techniques; caudal block , transversus abdominis plane (TAP) block and quadratus lumborum block (QLB) by comparing postoperative pain scores [ Face, Legs, Activity, Cry, Consolabilty(FLACC) and Visual Analogue Scale (VAS)], first analgesic requirement time and total analgesic consumption in pediatrics undergoing lower abdominal surgery. We also aim to observe the side effects of these techniques such as nausea, vomiting, bradycardia, hypotension, respiratory depression.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Bupivacaine

Detailed Description

Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides effective postoperative analgesia. Neuroaxial blocks such as epidural and caudal blocks is considered the gold standart regional technique for pain management after lower abdominal surgery, blocking both somatic and visceral pain. Nowadays,US is increasingly used to perform caudal block, demostrating cannule placement and precise deposition of local anesthetic in the epidural space. On the other side truncal blocks as US-guided TAP block covers T10-L1 dermatomes and provides postoperative pain relief after lower abdominal surgery with lower complication rate rather than caudal block but it may not prevent traction on the peritoneal sac. QLB is rather a new regional technique blocking nerve roots close to paravertebral area affecting somatic and visceral nerve fibers. In our study we aim to compare postoperative analgesic effects of these three techniques in paediatrics. Our primary outcomes are pain scores(FLACC/VAS) and first additional analgesic requirement time. Secondary outcomes are total analgesic consumption, side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), length of hospitalization and chronic pain due to incision after 2 months.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• undergoing lower abdominal surgery
• ASA(American Society of Anestesiology)1-2

Exclusion Criteria:

• denial of patient or parents,
• infection on the local anesthetic application area
• infection in central nervous system
• coagulopathy
• brain tumours
• known allergy against local anesthetics
• anatomical difficulties
• with preexisting cardiac dysfunction
• with history of renal and/or hepatic dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus Lumborum Block; US-guided quadratus lumborum block will be performed with 0,5 ml/kg 0.25% Bupivacaine in the anterior layer of the thoracolumbar fascia between psoas major and quadratus lumborum muscles	Drug: Bupivacaine; % 0,25; Other Names: Marcaine
Active Comparator: Transversus Abdominis Plane Block; US- guided transversus abdominis plane block will be performed with 0,5 ml/kg 0.25% Bupivacaine into the fascial plane between internal oblique muscle and transversus abdominis muscle	Drug: Bupivacaine; % 0,25; Other Names: Marcaine
Active Comparator: Caudal Block; US-guided caudal epidural block will be applied to 0.7 ml/kg 0.25 % Bupivacaine up to a maximum of 20 mL	Drug: Bupivacaine; % 0,25; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Face, Legs Activity, Cry, Consolability (FLACC) scores	It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.	up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Hospitalisation	Through study completion, an average of 1 week
Number of patients who require rescue analgesic	Number of patients who require IV tramadol (1 mg/kg) at the first 2 hours and parasetamol in the 48 hours	up to 48 hours
First analgesic requirement time	Duration of postoperative analgesia	Up to 48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of side effects	Nausea, vomiting	up to 48 hours
Incidence of complications	Hematoma, dural puncture, infections	up to first week
Time to first mobilization	Time to first mobilization	up to 48 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Publications and helpful links

Helpful Links

• Rectus sheath and transversus abdominis plane blocks in children: a systematic review and meta-analysis of randomized trials.
• Comparison of caudal epidural block and ultrasonography-guided transversus abdominis plane block for pain relief in children undergoing lower abdominal surgery.
• Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial.
• Ultrasound-Guided Transversus Abdominis Plane and Quadratus Lumborum Blocks

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2018
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound-guided; transversus abdominis plane block; quadratus lumborum block; caudal block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2018/1076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No