Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Postoperative Pain; Surgery; Analgesia; Scoliosis Idiopathic

Treatments: Other: Enhanced recovery pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT04038229

EC19/14/183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Standard of care

No Intervention group

Description:

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

Enhanced recovery pathway

Experimental group

Description:

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

Treatment:

Other: Enhanced recovery pathway