Scoliosis IdiopathicPhase 4NCT06789016
Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
A Phase 4 study testing Dexmedetomidine and 0.9%NaCl in people with Scoliosis Idiopathic and Scoliosis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis, Scoliosis; Adolescence
- What is being tested?
- Dexmedetomidine and 0.9%NaCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2025to 31 Mar 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children scheduled for idiopathic scoliosis surgery
- age >10 and <18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, 61-545
About this study
Official title: Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic
Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
Read the 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.
- Conditions
- Scoliosis Idiopathic, Scoliosis, Scoliosis; Adolescence
- Being tested
- Dexmedetomidine, 0.9%NaCl
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEX
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block
0.9%NaClDrug
Also called saline
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block
| Study group | Role | What they receive |
|---|---|---|
| DEXMEDETOIDINE | Active comparator | 0.2% ropivacaine 0.5ml/kg+ 0.1ug/kg Dexamethasone for erector spinae plane block Receives: Drug: Dexmedetomidine |
| CONTROL | Active comparator | 0.2% ropivacaine 0.5ml/kg for erector spinae plane block Receives: Drug: 0.9%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
First need of opioid analgesia
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after surgery
Secondary outcomes (12)
Opioid consumption
Total opiate consumption after surgery
Measured: 48 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 4 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 8 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 12 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 24 hours after surgery
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Measured: 48 hours after surgery
Nerve damage [range 0-4]
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)
Measured: 12 hours after surgery
Nerve damage [range 0-4]
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)
Measured: 24 hours after surgery
Nerve damage [range 0-4]
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)
Measured: 48 hours after surgery
adverce effects
nausea, vomitting, bradycardia, hypotension
Measured: durring surgery
adverce effects
nausea, vomitting, bradycardia, hypotension
Measured: 48 hours after surgery
MEP
motor evoced potentials
Measured: durring surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Feb 2025
- Primary completion25 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789016
- Sponsor's protocol ID
- 12/2024
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes