NCT06789016

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

January 17, 2025

Last Update Submit

April 7, 2026

Conditions

Scoliosis IdiopathicScoliosisScoliosis; Adolescence

Outcome Measures

Primary Outcomes (1)

  • First need of opioid analgesia

    Time after surgery when the patient needs opiate for the first time

    48 hours after surgery

Secondary Outcomes (12)

  • Opioid consumption

    48 hours after surgery

  • Numerical Rating Scale [range 0:10]

    4 hours after surgery

  • Numerical Rating Scale [range 0:10]

    8 hours after surgery

  • Numerical Rating Scale [range 0:10]

    12 hours after surgery

  • Numerical Rating Scale [range 0:10]

    24 hours after surgery

  • +7 more secondary outcomes

Study Arms (2)

DEXMEDETOIDINE

ACTIVE COMPARATOR

0.2% ropivacaine 0.5ml/kg+ 0.1ug/kg Dexamethasone for erector spinae plane block

Drug: Dexmedetomidine

CONTROL

ACTIVE COMPARATOR

0.2% ropivacaine 0.5ml/kg for erector spinae plane block

Drug: 0.9%NaCl

Interventions

DexmedetomidineDRUG

administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block

Also known as: DEX
DEXMEDETOIDINE
0.9%NaClDRUG

administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block

Also known as: saline
CONTROL

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Poznan, Wielkopolska, 61-545, Poland

Location

MeSH Terms

Conditions

Scoliosis

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

February 1, 2025

Primary Completion

March 25, 2026

Study Completion

March 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations

PL(1)