- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183049
Improved Rehabilitation After Spinal Surgery in Adolescents
Improved Rehabilitation After Spinal Surgery in Adolescents: Prospective Observational Epidemiological Study of a Protocol Without Opioid
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Loire-Atlantique
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Nantes, Loire-Atlantique, France, 44000
- Nantes University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patent with idiopathic or secondary surgical scoliosis
- Management by the paediatric anaesthesia team at the Mother and Child - Hospital of the University Hospital of Nantes
- Non-opposition to inclusion in the study collected orally from the patient and parents
- Satisfying oral and written comprehension of the French language, without interpreter
- Ability to participate in a telephone interview
Exclusion Criteria:
- Patient that does not understand French correctly
- Patient unable to express himself/herself correctly in French
- Patient with a non-scoliotic surgical spinal pathology
- Refusal to participate in the study
- Absence of a record of non-opposition to participation in the study from the patient and his or her parents
- Cerebral palsy or any other condition that does not allow participation in a telephone interview without particular difficulty.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
Time Frame: Three months after surgery
|
Pain at the surgical site, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
|
Three months after surgery
|
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
Time Frame: Sixth months after surgery
|
Pain at the surgical site, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
|
Sixth months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of a postoperative opioid-related adverse event
Time Frame: Within the first 48 hours after extubation
|
postoperative hypoxemia or PONV (postoperative nausea and vomiting) or excessive sedation. Postoperative hypoxemia is defined as an oxygen saturation (SpO2) < 95% with a need for oxygen supplementation within the first 48h after extubation. PONV is defined by use of antiemetics of PONV within the first 48h after extubation. Excessive sedation is defined by a score of 3 in a scale of sedation wich is S1 awake, S2 mild drowsiness, S3 non awakenable. |
Within the first 48 hours after extubation
|
Level of preoperative quality of life
Time Frame: Three month after surgery
|
SRS-30 score (Scoliosis Research Society Health-Related Quality of Life Questionnaire), during a telephone interview.
Score between 1 and 5 where 5 is the higher level of quality of live.
|
Three month after surgery
|
Postoperative opioid consumption
Time Frame: Within the 2 first weeks postsurgery
|
Cumulative consumption of opioid in mg/kg.
|
Within the 2 first weeks postsurgery
|
Level of preoperative quality of life: SRS-30 score
Time Frame: Sixth month after surgery
|
SRS-30 score (Scoliosis Research Society Health-Related Quality of Life Questionnaire), during a telephone interview.
Score between 1 and 5 where 5 is the higher level of quality of live.
|
Sixth month after surgery
|
Postoperative rehabilitation
Time Frame: Within the first 2 weeks postsurgery
|
Number of days between surgery and first deambulation
|
Within the first 2 weeks postsurgery
|
Length of stay in the hospital
Time Frame: Within the first 2 weeks postsurgery
|
Number of days in the hospital.
|
Within the first 2 weeks postsurgery
|
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
Time Frame: Two weeks before surgery
|
State trait anxiety Inventory for Children (STAIC) score evaluated during a telephone interview.
Score between 20 and 60, where 60 is the higher level of anxiety
|
Two weeks before surgery
|
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
Time Frame: three months after surgery
|
State trait anxiety Inventory for Children (STAIC) score evaluated during a telephone interview.
Score between 20 and 60, where 60 is the higher level of anxiety
|
three months after surgery
|
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
Time Frame: sixth months after surgery
|
State trait anxiety Inventory for Children (STAIC) score evaluated during a telephone interview.
Score between 20 and 60, where 60 is the higher level of anxiety
|
sixth months after surgery
|
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Time Frame: Three months after surgery
|
Modified DN4 score superior at 4.
|
Three months after surgery
|
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Time Frame: Six months after surgery
|
Modified DN4 score superior at 4.
|
Six months after surgery
|
Postoperative antalgics consumption other than opioid
Time Frame: Within the first 2 weeks postsurgery
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Cumulative antalgics consumption other than opioid.
|
Within the first 2 weeks postsurgery
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Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA.
Time Frame: Two weeks before surgery
|
Back pain, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
|
Two weeks before surgery
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Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Time Frame: Two weeks before surgery, three and sixth months after surgery
|
Pain castrophizing scale for adolescent, score evaluated during a telephone interview.
Score between 0 and 52, where 52 is the higher level of catastrophism.
|
Two weeks before surgery, three and sixth months after surgery
|
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Time Frame: three months after surgery
|
Pain castrophizing scale for adolescent, score evaluated during a telephone interview.
Score between 0 and 52, where 52 is the higher level of catastrophism.
|
three months after surgery
|
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Time Frame: sixth months after surgery
|
Pain castrophizing scale for adolescent, score evaluated during a telephone interview.
Score between 0 and 52, where 52 is the higher level of catastrophism.
|
sixth months after surgery
|
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Time Frame: Two weeks before surgery, three and sixth months after surgery
|
Pain castrophizing scale for adult, score evaluated during a telephone interview.
Score between 0 and 52, where 52 is the higher level of catastrophism.
|
Two weeks before surgery, three and sixth months after surgery
|
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Time Frame: three months after surgery
|
Pain castrophizing scale for adult, score evaluated during a telephone interview.
Score between 0 and 52, where 52 is the higher level of catastrophism.
|
three months after surgery
|
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Time Frame: sixth months after surgery
|
Pain castrophizing scale for adult, score evaluated during a telephone interview.
Score between 0 and 52, where 52 is the higher level of catastrophism.
|
sixth months after surgery
|
Level of preoperative quality of life.
Time Frame: Two weeks before surgery
|
SRS-22 score (Scoliosis Research Society Health-Related Quality of Life Questionnaire), during a telephone interview.
Score between 1 and 5 where 5 is the higher level of quality of live
|
Two weeks before surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Corine LEJUS, PUPH, CHU de Nantes
- Principal Investigator: Guy LETELLIER, PH, ESEAN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC19_0255
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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