Clinical trial NCT04038229: Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery
Official title: Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Scoliosis Idiopathic
Surgery
Postoperative Pain
Keywords: enhanced recovery pathway
analgesia
tele-monitoring
biopsychosocial evaluation
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 33
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative pain
timeFrame: From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively
Secondary outcomes:
measure: evaluation of opioid-related side effect
timeFrame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
measure: sleep
timeFrame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
measure: daily activity
timeFrame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
measure: mobility
timeFrame: From day of surgery until hospital discharge (approximately 7 days)
Other outcomes:
measure: State-Trait anxiety Inventory (STAI)
timeFrame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
measure: Multidimensional Pain Inventory (MPI, Part 1)
timeFrame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
measure: Child and Adolescent Social and Adaptive Scale (CASAFS)
timeFrame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
measure: Childhood Depression Inventory (CDI-2)
timeFrame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
measure: Pain Response Inventory (PRI)
timeFrame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Guy Hans, MD, PhD
role: STUDY_CHAIR
References: