Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Phase 4

Completed

• Conditions: Scoliosis Idiopathic; Scoliosis; Adolescence
• Interventions: Drug: 0.9% sodium chloride; Drug: Dexamethasone; Drug: Dexmedetomidine

• Registration Number: NCT06086431
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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

Detailed Description

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

After scoliosis surgery, children need good analgesia. 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 Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study Start: 2023-10-17
• Study First Posted: 2023-10-17
• Status Verified: 2024-01
• Primary Completion: 2024-09-24
• Study Completion: 2024-11-05
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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
Placebo	0.9% sodium chloride	0.2% ropivacaine for erector spinae plane block
Dexamethasone	Dexamethasone	0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
Dexmedetomidine	Dexmedetomidine	0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	48 hours	Total opiate consumption after surgery
Numerical Rating Scale [range 0:10]	24 hours after surgery	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
NLR	24 and 48 hours after surgery	Neutrophil-to-lymphocyte ratio
PLR	24 and 48 hours after surgery]	Platelet-to-lymphocyte ratio
MEP	durring surgery	motor evoced potentials
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

Trial Locations

Locations (1)

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