Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Phase 4

Not yet recruiting

• Conditions: Scoliosis Idiopathic; Scoliosis; Scoliosis; Adolescence
• Interventions: Drug: Dexmedetomidine; Drug: 0.9%NaCl

• Registration Number: NCT06789016
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Detailed Description

This study proposes to explore the effect of perineurial Dexmedetomidine on the duration of erector spinal plane block for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-02-01
• Primary Completion: 2025-05-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

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

Inclusion Criteria

• children scheduled for idiopathic scoliosis surgery
• age >10 and <18 years

Exclusion Criteria

• age < 10 years
• age < 18 years
• infection at the site of the regional blockade
• coagulation disorders
• immunodeficiency
• ASA= or >4
• steroid medication in regular use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXMEDETOIDINE	Dexmedetomidine	0.2% ropivacaine 0.5ml/kg+ 0.1ug/kg Dexamethasone for erector spinae plane block
CONTROL	0.9%NaCl	0.2% ropivacaine 0.5ml/kg for erector spinae plane block

Primary Outcome Measures

Name	Time	Method
First need of opioid analgesia	48 hours after surgery	Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	48 hours after surgery	Total opiate consumption after surgery
Numerical Rating Scale [range 0:10]	48 hours after surgery	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Nerve damage [range 0-4]	48 hours after surgery	Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
adverce effects	48 hours after surgery	nausea, vomitting, bradycardia, hypotension
MEP	durring surgery	motor evoced potentials

Trial Locations

Locations (1)

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland; 🇵🇱 Poznań, Wielkopolska, Poland