An observational study in Pain, Postoperative, Pain and Scoliosis, sponsored by Nantes University Hospital. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by Nantes University Hospital · Observational
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 622 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Nantes University Hospital is the lead sponsor of 836 studies on the registry; 196 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- As the study concerns a specifically paediatric pathology, minors will not be excluded from the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: Sixth months after surgery
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.
Time frame: 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.
Time frame: Three month after surgery
Postoperative opioid consumption
Cumulative consumption of opioid in mg/kg.
Time frame: 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.
Time frame: Sixth month after surgery
Postoperative rehabilitation
Number of days between surgery and first deambulation
Time frame: Within the first 2 weeks postsurgery
Length of stay in the hospital
Number of days in the hospital.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: sixth months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Modified DN4 score superior at 4.
Time frame: Three months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Modified DN4 score superior at 4.
Time frame: Six months after surgery
Postoperative antalgics consumption other than opioid
Cumulative antalgics consumption other than opioid.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Two weeks before surgery
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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