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Completed

NCT Number: NCT04038229

Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

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.

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Key information

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Recovery pathway

Other

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

Primary outcomes

  1. postoperative pain

    Time frame: 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 outcomes

  1. evaluation of opioid-related side effect

    Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

    Evaluation of opioid-related side effect as nausea, vomiting and pruritus

  2. sleep

    Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

    Subjective sleep score using 11 point numeric rating scale

  3. daily activity

    Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

    Subjective activity score using 11 point numeric rating scale

  4. mobility

    Time frame: From day of surgery until hospital discharge (approximately 7 days)

    Daily mobility assessment by attending physiotherapist on 4 point scale

Other outcomes

  1. State-Trait anxiety Inventory (STAI)

    Time frame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

    evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform

  2. Multidimensional Pain Inventory (MPI, Part 1)

    Time frame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

    Screening for pain and psychosocial aspects

  3. Child and Adolescent Social and Adaptive Scale (CASAFS)

    Time frame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

    Screening for pain and psychosocial aspects

  4. Childhood Depression Inventory (CDI-2)

    Time frame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

    screening for depression

  5. Pain Response Inventory (PRI)

    Time frame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

    screening for pain coping

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 30, 2019
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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