Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Analgesia; Surgery; Scoliosis Idiopathic
• Intervention / Treatment: Other: Enhanced recovery pathway

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait anxiety Inventory (STAI)	evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Multidimensional Pain Inventory (MPI, Part 1)	Screening for pain and psychosocial aspects	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Child and Adolescent Social and Adaptive Scale (CASAFS)	Screening for pain and psychosocial aspects	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Childhood Depression Inventory (CDI-2)	screening for depression	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Pain Response Inventory (PRI)	screening for pain coping	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Study Chair: Guy Hans, MD, PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: analgesia; enhanced recovery pathway; tele-monitoring; biopsychosocial evaluation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: EC19/14/183

Drug and device information, study documents

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