Improved Rehabilitation After Spinal Surgery in Adolescents

Nantes University Hospital30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pain, Postoperative Pain Scoliosis Spinal Fusion

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Nantes University Hospital

Nantes, Loire-Atlantique, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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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