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Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.
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.
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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- As the study concerns a specifically paediatric pathology, minors will not be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Corine LEJUS, PUPH | Nantes University Hospital | Principal Investigator |
| Guy LETELLIER, PH | Establishment for Children and Adolescents in the Nantes Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | Loire-Atlantique | 44000 | France |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| 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 |
| D012816 | Signs and Symptoms |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |