Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

Not Applicable

Completed

• Conditions: Analgesia; Scoliosis Idiopathic; Surgery; Postoperative Pain
• Interventions: Other: Enhanced recovery pathway

• Registration Number: NCT04038229
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-30
• Study Start: 2019-12-09
• Primary Completion: 2021-11-03
• Study Completion: 2022-01-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Enhanced recovery pathway	Enhanced recovery pathway	Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol

Primary Outcome Measures

Name	Time	Method
postoperative pain	From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium