University hospital Antwerp
Edegem, Antwerp, 2650, Belgium
NCT Number: NCT04038229
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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Notify MeUp to 25 year
All sexes
Interventional
Not applicable
Edegem, Antwerp, 2650, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term
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
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
Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
Subjective sleep score using 11 point numeric rating scale
Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
Subjective activity score using 11 point numeric rating scale
Time frame: From day of surgery until hospital discharge (approximately 7 days)
Daily mobility assessment by attending physiotherapist on 4 point scale
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
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
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
Time frame: 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
screening for depression
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
University Hospital, Antwerp
Other
Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis
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