Clinical trial NCT03780790: Comparing Analgesic Effects of Three Ultrasound Guided Regional Anesthetic Techniques in Pediatrics
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Keywords: quadratus lumborum block
transversus abdominis plane block
caudal block
ultrasound-guided
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 135
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Face, Legs Activity, Cry, Consolability (FLACC) scores
timeFrame: up to 48 hours
Secondary outcomes:
measure: Hospital stay
timeFrame: Through study completion, an average of 1 week
measure: Number of patients who require rescue analgesic
timeFrame: up to 48 hours
measure: First analgesic requirement time
timeFrame: Up to 48 hours
Other outcomes:
measure: Incidence of side effects
timeFrame: up to 48 hours
measure: Incidence of complications
timeFrame: up to first week
measure: Time to first mobilization
timeFrame: up to 48 hours
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Meltem Savran Karadeniz
role: PRINCIPAL_INVESTIGATOR
References: