Analgesia, Postoperative Pain, Scoliosis Idiopathic, Surgery
Conditions
Keywords
enhanced recovery pathway, analgesia, tele-monitoring, biopsychosocial evaluation
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.
Interventions
The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term
Sponsors
University Hospital, Antwerp
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| sleep | From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery | Subjective sleep score using 11 point numeric rating scale |
| daily activity | From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery | Subjective activity 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| State-Trait anxiety Inventory (STAI) | 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 |
| Multidimensional Pain Inventory (MPI, Part 1) | 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 |
| Child and Adolescent Social and Adaptive Scale (CASAFS) | 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 |
| Childhood Depression Inventory (CDI-2) | 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery | screening for depression |
| Pain Response Inventory (PRI) | 3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery | screening for pain coping |
Countries
Belgium
Outcome results
None listed