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Completed

NCT Number: NCT04183049

Improved Rehabilitation After Spinal Surgery in Adolescents

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

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Key information

Conditions

Pain, Postoperative Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Scoliosis Signs and Symptoms Spinal Curvatures Spinal Diseases Spinal Fusion

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA

    Time frame: Three 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.

  2. Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA

    Time frame: 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 outcomes

  1. Occurence of a postoperative opioid-related adverse event

    Time frame: 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.

  2. Level of preoperative quality of life

    Time frame: 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.

  3. Postoperative opioid consumption

    Time frame: Within the 2 first weeks postsurgery

    Cumulative consumption of opioid in mg/kg.

  4. Level of preoperative quality of life: SRS-30 score

    Time frame: 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.

  5. Postoperative rehabilitation

    Time frame: Within the first 2 weeks postsurgery

    Number of days between surgery and first deambulation

  6. Length of stay in the hospital

    Time frame: Within the first 2 weeks postsurgery

    Number of days in the hospital.

  7. Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA

    Time frame: Two weeks before 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

  8. Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA

    Time frame: three 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

  9. Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA

    Time frame: 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

  10. Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.

    Time frame: Three months after surgery

    Modified DN4 score superior at 4.

  11. Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.

    Time frame: Six months after surgery

    Modified DN4 score superior at 4.

  12. Postoperative antalgics consumption other than opioid

    Time frame: Within the first 2 weeks postsurgery

    Cumulative antalgics consumption other than opioid.

  13. Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA.

    Time frame: 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.

  14. Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.

    Time frame: Two weeks before surgery, three and 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.

  15. Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.

    Time frame: three 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.

  16. Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.

    Time frame: 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.

  17. Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.

    Time frame: Two weeks before surgery, three and 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.

  18. Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.

    Time frame: three 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.

  19. Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.

    Time frame: 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.

  20. Level of preoperative quality of life.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2019
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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