Pain, Pain, Postoperative, Scoliosis, Spinal Fusion
Conditions
Keywords
Dexmedetomidine, Analgesics, Opioid free anesthesia, Chronic postsurgical pain
Brief summary
Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.
Detailed description
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.
Interventions
None listed
Sponsors
Nantes University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of preoperative quality of life | 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. |
| Postoperative opioid consumption | Within the 2 first weeks postsurgery | Cumulative consumption of opioid in mg/kg. |
| Level of preoperative quality of life: SRS-30 score | 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. |
| Postoperative rehabilitation | Within the first 2 weeks postsurgery | Number of days between surgery and first deambulation |
| Length of stay in the hospital | Within the first 2 weeks postsurgery | Number of days in the hospital. |
| Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA | 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 |
| Occurence of a postoperative opioid-related adverse event | 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. |
| Postoperative antalgics consumption other than opioid | Within the first 2 weeks postsurgery | Cumulative antalgics consumption other than opioid. |
| Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA. | 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. |
| Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA. | 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. |
| Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA. | 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. |
| Level of preoperative quality of life. | 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 |
| Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA. | Three months after surgery | Modified DN4 score superior at 4. |
Countries
France
Outcome results
None listed