Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04038229
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2019-07-26
Brief Title:
Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None