Improved Rehabilitation After Spinal Surgery in Adolescents

Completed

• Conditions: Pain, Postoperative; Spinal Fusion; Pain; Scoliosis

• Registration Number: NCT04183049
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Study Start: 2019-12-18
• Status Verified: 2021-08
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA	Sixth 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 Outcome Measures

Name	Time	Method
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 opioid consumption	Within the 2 first weeks postsurgery	Cumulative consumption of opioid in mg/kg.
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.	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.
Length of stay in the hospital	Within the first 2 weeks postsurgery	Number of days in the hospital.
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.	Six months after surgery	Modified DN4 score superior at 4.
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.
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
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 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
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA	sixth months after 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
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.	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.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France