Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery

Not Applicable

Completed

• Conditions: Anesthesia, Local
• Interventions: Drug: Bupivacaine 0.5 ml/kg; Drug: Bupivacaine 0.7 ml/kg

• Registration Number: NCT04204343
• Lead Sponsor: Istanbul University

Brief Summary

Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects, time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Detailed Description

Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Blockade of dermatomes between T6 and L1 commonly provides effective postoperative analgesia. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques as they provide both somatic and visceral analgesia. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In the present study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal surgery. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Primary Completion: 2022-01-15
• Study Completion: 2022-02-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• undergoing upper abdominal surgery
• ASA(American Society of Anesthesiology)1-2

Exclusion Criteria

• denial of patient or parents
• infection on the local anesthetic application area
• infection in the central nervous system
• coagulopathy
• brain tumors
• known allergy against local anesthetics
• anatomical difficulties
• with preexisting cardiac dysfunction
• with history of renal and/or hepatic dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block	Bupivacaine 0.5 ml/kg	US-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine
Caudal Block	Bupivacaine 0.7 ml/kg	US-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine

Primary Outcome Measures

Name	Time	Method
The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale	up to 48 hours	Pain scores between 0-10

Secondary Outcome Measures

Name	Time	Method
Time to first analgesic	up to 48 hours	Duration of postoperative analgesia
Incidence of side effects/complications	up to first week	hematoma, dural puncture, infections
Time to first mobilization	up to 48 hours	time to first mobilization
Presence of pain (chronic pain - Visual Analog scale>3)	3 months	Chronic pain due to incision after 2-3 months
length of hospital stay	through study completion, an average of 1 week	hospitalisation
number patients who require rescue analgesic	up to 48 hours	number of patients who require IV morphine (0.03 mg/kg) during the first 2 hours and paracetamol in the 48 hours

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey