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

Anesthesia, Local Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780790
• Other study ID #: 2018/1076
• Status: Completed
• Phase: N/A
• Start date: December 28, 2018
• Est. completion date: February 25, 2021

Study information

• Verified date: March 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: February 25, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• Bupivacaine
% 0,25

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of side effects	Nausea, vomiting	up to 48 hours
Other	Incidence of complications	Hematoma, dural puncture, infections	up to first week
Other	Time to first mobilization	Time to first mobilization	up to 48 hours
Primary	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	Hospital stay	Hospitalisation	Through study completion, an average of 1 week
Secondary	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
Secondary	First analgesic requirement time	Duration of postoperative analgesia	Up to 48 hours

External Links

•   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.
•   Rectus sheath and transversus abdominis plane blocks in children: a systematic review and meta-analysis of randomized trials.
•   Ultrasound-Guided Transversus Abdominis Plane and Quadratus Lumborum Blocks