Clinical trial NCT04183049: Improved Rehabilitation After Spinal Surgery in Adolescents
Official title: Improved Rehabilitation After Spinal Surgery in Adolescents: Prospective Observational Epidemiological Study of a Protocol Without Opioid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Pain
Scoliosis
Spinal Fusion
Keywords: Dexmedetomidine
Analgesics
Opioid free anesthesia
Chronic postsurgical pain
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - As the study concerns a specifically paediatric pathology, minors will not be excluded from the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
timeFrame: Three months after surgery
measure: Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
timeFrame: Sixth months after surgery
Secondary outcomes:
measure: Occurence of a postoperative opioid-related adverse event
timeFrame: Within the first 48 hours after extubation
measure: Level of preoperative quality of life
timeFrame: Three month after surgery
measure: Postoperative opioid consumption
timeFrame: Within the 2 first weeks postsurgery
measure: Level of preoperative quality of life: SRS-30 score
timeFrame: Sixth month after surgery
measure: Postoperative rehabilitation
timeFrame: Within the first 2 weeks postsurgery
measure: Length of stay in the hospital
timeFrame: Within the first 2 weeks postsurgery
measure: Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
timeFrame: Two weeks before surgery
measure: Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
timeFrame: three months after surgery
measure: Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
timeFrame: sixth months after surgery
measure: Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
timeFrame: Three months after surgery
measure: Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
timeFrame: Six months after surgery
measure: Postoperative antalgics consumption other than opioid
timeFrame: Within the first 2 weeks postsurgery
measure: Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA.
timeFrame: Two weeks before surgery
measure: Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
timeFrame: Two weeks before surgery, three and sixth months after surgery
measure: Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
timeFrame: three months after surgery
measure: Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
timeFrame: sixth months after surgery
measure: Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
timeFrame: Two weeks before surgery, three and sixth months after surgery
measure: Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
timeFrame: three months after surgery
measure: Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
timeFrame: sixth months after surgery
measure: Level of preoperative quality of life.
timeFrame: Two weeks before surgery
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Corine LEJUS, PUPH
role: PRINCIPAL_INVESTIGATOR
affiliation: ESEAN
name: Guy LETELLIER, PH
role: PRINCIPAL_INVESTIGATOR
References: