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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-28

Study Completion Date

2021-02-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RANDOMISED DOUBLE BLINDED INTERVENTIONAL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

% 0,25

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

% 0,25

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

% 0,25

Interventions

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Bupivacaine

% 0,25

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No