Clinical trial NCT06086431: Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
Official title: Dexamethasone Vs. Dexmedetomidine for Erector Spine Plane Block in Pain Management After Pediatric Idiopathic Scoliosis Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scoliosis Idiopathic
Scoliosis; Adolescence
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: first need of opiate
timeFrame: 48 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: 48 hours
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 16 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 20 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: NLR
timeFrame: 24 and 48 hours after surgery
measure: PLR
timeFrame: 24 and 48 hours after surgery]
measure: MEP
timeFrame: durring surgery
measure: Nerve damage [range 0-4]
timeFrame: 12 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 24 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 48 hours after surgery
measure: adverce effects
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
Study officials:
affiliation: Poznan University of Medical Sciences
name: Tomasz Kotwicki, Prof.dr hab.
role: STUDY_DIRECTOR
References: