Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03780790
Enrollment
135
Registered
2018-12-19
Start date
2018-12-28
Completion date
2021-02-25
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Keywords

quadratus lumborum block, transversus abdominis plane block, caudal block, ultrasound-guided

Brief summary

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.

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.

Interventions

DRUGBupivacaine

% 0,25

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

RANDOMISED DOUBLE BLINDED INTERVENTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Face, Legs Activity, Cry, Consolability (FLACC) scoresup to 48 hoursIt 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.

Secondary

MeasureTime frameDescription
Hospital stayThrough study completion, an average of 1 weekHospitalisation
Number of patients who require rescue analgesicup to 48 hoursNumber of patients who require IV tramadol (1 mg/kg) at the first 2 hours and parasetamol in the 48 hours
First analgesic requirement timeUp to 48 hoursDuration of postoperative analgesia

Other

MeasureTime frameDescription
Incidence of complicationsup to first weekHematoma, dural puncture, infections
Time to first mobilizationup to 48 hoursTime to first mobilization
Incidence of side effectsup to 48 hoursNausea, vomiting

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026