Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

Study Overview
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Brief Summary
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Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain. The consequences of untreated acute pain are known and can also contribute to chronification in pain.

Detailed Description
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Surgical correction of adolescent idiopathic scoliosis (AIS) is indicated for severe deformity. Posterior Spinal fusion (PSF) for AIS is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by a large surgical incision, extensive tissue trauma, risk of blood loss, longer operating times and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. All of this can, along with under-treatment of postoperative pain, be an important delaying factor in postoperative recovery and rehabilitation with a late hospital discharge and increased patient dissatisfaction. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain. The consequences of untreated pain are known and can also contribute to chronification in pain. The incidence of chronic post-surgical pain after scoliosis fusion is 22% at 6 months and 11-15% at 1 to 5 years postoperatively. It is therefore important to minimize the pain during the first postoperative days. Untreated pain in patients is far from benign with significant negative short and long term consequences with accompanying reduction in rehabilitation duration, sleep quality of life. To date, there is no scientific evidence that some analgesic policy is superior, making adequate and safe pain relief and associated anti-emetic therapy after PSF a challenge makes for all healthcare providers involved.

Official Title
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Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis

Conditions
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Analgesia, Scoliosis Idiopathic, Surgery, Postoperative Pain

Intervention / Treatment
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* Other: Enhanced recovery pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: approved written informed consent by parent or legal representative idiopathic adolescent scoliosis planned for elective surgery: posterior spinal fusion Exclusion Criteria: other types of scoliosis chronic opioid usage (more than 3 months) known unstable psychiatric medical condition

Ages Eligible for Study
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Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis | |
| Experimental: Enhanced recovery pathway<br>Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol | Other: Enhanced recovery pathway<br>* The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Evaluation of pain at rest and during mobilization using 11 point numeric rating scale daily during hospital admission and is continued after discharge up to 3 months postoperatively | From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of opioid-related side effect | Evaluation of opioid-related side effect as nausea, vomiting and pruritus | From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery | 
| sleep | Subjective sleep score using 11 point numeric rating scale | From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery | 
| daily activity | Subjective activity score using 11 point numeric rating scale | From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery | 
| mobility | Daily mobility assessment by attending physiotherapist on 4 point scale | From day of surgery until hospital discharge (approximately 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, enhanced recovery pathway, tele-monitoring, biopsychosocial evaluation