RACHIDOL: Evaluation of Pain Following Scoliosis Surgery.
Sponsor
Rennes University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03686371
Collaborator
(none)
60
1
24
2.5
Study Details
Study Description
Brief Summary
The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Pain Following Scoliosis Surgery.- RACHIDOL
Actual Study Start Date
:
Jan 2, 2018
Anticipated Primary Completion Date
:
Aug 2, 2019
Anticipated Study Completion Date
:
Jan 2, 2020
Outcome Measures
Primary Outcome Measures
- Visual Analog Score for pain [3 days after inclusion]
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
to 18 Years
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Rennes | Rennes | France | 35033 |
Sponsors and Collaborators
- Rennes University Hospital
Investigators
- Principal Investigator: Anne DEFONTAINE, MD, Rennes University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT03686371
Other Study ID Numbers:
- 35RC17_3088_RACHIDOL
First Posted:
Sep 26, 2018
Last Update Posted:
Sep 26, 2018
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: