Improved Rehabilitation After Spinal Surgery in Adolescents

Improved Rehabilitation After Spinal Surgery in Adolescents: Prospective Observational Epidemiological Study of a Protocol Without Opioid

Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44000
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- As the study concerns a specifically paediatric pathology, minors will not be excluded from the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Sixth months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Three month after surgery
Postoperative opioid consumption	Cumulative consumption of opioid in mg/kg.	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.	Sixth month after surgery
Postoperative rehabilitation	Number of days between surgery and first deambulation	Within the first 2 weeks postsurgery
Length of stay in the hospital	Number of days in the hospital.	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	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	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	sixth months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.	Modified DN4 score superior at 4.	Three months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.	Modified DN4 score superior at 4.	Six months after surgery
Postoperative antalgics consumption other than opioid	Cumulative antalgics consumption other than opioid.	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.	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.	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.	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.	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.	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.	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.	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	Two weeks before surgery

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Corine LEJUS, PUPH, CHU de Nantes; Principal Investigator: Guy LETELLIER, PH, ESEAN

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Opioid free anesthesia; Analgesics; Chronic postsurgical pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Pain, Postoperative; Scoliosis
• Other Study ID Numbers: RC19_0255

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No