Improved Rehabilitation After Spinal Surgery in Adolescents

Study Overview
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Brief Summary
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Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.

Detailed Description
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RACAROFA is an observational, prospective study based on the hypothesis that the OFA technique effectively improves the long-term postoperative rehabilitation of adolescents and reduces the incidence of CPSP. A prospective French multicentre study on this topic is currently not feasible, as other multicentre studies (pain monitoring by the ANI, blood saving strategy) would interfere with potential recruitment.

Official Title
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Improved Rehabilitation After Spinal Surgery in Adolescents: Prospective Observational Epidemiological Study of a Protocol Without Opioid

Conditions
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Pain, Postoperative, Pain, Scoliosis, Spinal Fusion

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 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 | 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 | 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 | 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 | Cumulative consumption of opioid in mg/kg. | Within the 2 first weeks postsurgery | 
| Level of preoperative quality of life: SRS-30 score | 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 | Number of days between surgery and first deambulation | Within the first 2 weeks postsurgery | 
| Length of stay in the hospital | 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 | 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 | 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 | 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. | Modified DN4 score superior at 4. | Three months after surgery | 
| Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA. | Modified DN4 score superior at 4. | Six months after surgery | 
| Postoperative antalgics consumption other than opioid | Cumulative antalgics consumption other than opioid. | Within the first 2 weeks postsurgery | 
| Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA. | 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 | 
| Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Analgesics, Opioid free anesthesia, Chronic postsurgical pain