Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

NCT ID: NCT04038229

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2022-01-01

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.

Conditions

Analgesia; Scoliosis Idiopathic; Surgery; Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Enhanced recovery pathway

Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol

Group Type: EXPERIMENTAL

Enhanced recovery pathway

Intervention Type: OTHER

The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term

Interventions

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

Intervention Type: OTHER

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

• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Davina Wildemeersch

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guy Hans, MD, PhD

Role: STUDY_CHAIR

University Hospital, Antwerp

Locations

University hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

EC19/14/183

Identifier Type: -

Identifier Source: org_study_id