Clinical trial

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

Name

14/2023

Description

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

Trial arms

Trial start

2023-10-17

Estimated PCD

2024-08-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Placebo

Other names:

placebo

Dexamethasone

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

Arms:

Dexamethasone

Dexmedetomidine

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

Arms:

Dexmedetomidine

Size

Primary endpoint

first need of opiate

48 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-01-23

1 organization

2 products

1 drug

1 indication

Organization

Poznan University of Medical Sciences

Drug

Indication

Product

Product