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

Scoliosis Idiopathic Clinical Trial

Official title:

Dexamethasone vs. Dexmedetomidine for Erector Spine Plane Block in Pain Management After Pediatric Idiopathic Scoliosis Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086431
• Other study ID #: 14/2023
• Status: Recruiting
• Phase: Phase 4
• Start date: October 17, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, Ph.D.
• Phone: +48 608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence

Intervention

Drug:
• 0.9% sodium chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block
• Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block
• Dexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block

Locations

Country	Name	City	State
Poland	Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznan, Poland	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours
Secondary	Opioid consumption	Total opiate consumption after surgery	48 hours
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	4 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	8 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	12 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	16 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	20 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	24 hours after surgery
Secondary	NLR	Neutrophil-to-lymphocyte ratio	24 and 48 hours after surgery
Secondary	PLR	Platelet-to-lymphocyte ratio	24 and 48 hours after surgery]