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

I

Istanbul University

Status

Completed

Conditions

Anesthesia, Local

Treatments

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03780790
2018/1076

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

All

Ages

12 months to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

135 participants in 3 patient groups

Quadratus Lumborum Block
Active Comparator group
Description:
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
Treatment:
Drug: Bupivacaine
Transversus Abdominis Plane Block
Active Comparator group
Description:
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
Treatment:
Drug: Bupivacaine
Caudal Block
Active Comparator group
Description:
US-guided caudal epidural block will be applied to 0.7 ml/kg 0.25 % Bupivacaine up to a maximum of 20 mL
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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