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NCT03686371 Clinical Trial

Evaluation of Pain Following Scoliosis Surgery.

Idiopathic Scoliosis Clinical Trial

— RACHIDOL  

Official title:
Evaluation of Pain Following Scoliosis Surgery.- RACHIDOL

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03686371
Other study ID # 35RC17_3088_RACHIDOL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2018
Est. completion date June 30, 2019

Study information
Verified date April 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date June 30, 2019
Est. primary completion date October 23, 2018
Accepts healthy volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - adolescent from 10 to 18 years of age - idiopathic scoliosis - posterior surgery for spinal arthrodesis - non opposition children and parents Exclusion Criteria: - complication following surgery needing reoperation - secondary intervention - anterior surgery - non idiopathic scoliosis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• posterior surgery for spinal arthrodesis
posterior surgery for spinal arthrodesis

Locations
Country Name City State
France CHU de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analog Score for pain (EVA) The assessment criteria used is the numerical pain scale from 0 to 10(0 = no pain, 10 = extremely painful 3 days after inclusion
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