Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038229
• Other study ID #: EC19/14/183
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 1, 2022
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Postoperative Pain
• Scoliosis
• Scoliosis Idiopathic
• Surgery

Intervention

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

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	State-Trait anxiety Inventory (STAI)	evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Other	Multidimensional Pain Inventory (MPI, Part 1)	Screening for pain and psychosocial aspects	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Other	Child and Adolescent Social and Adaptive Scale (CASAFS)	Screening for pain and psychosocial aspects	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Other	Childhood Depression Inventory (CDI-2)	screening for depression	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Other	Pain Response Inventory (PRI)	screening for pain coping	3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery
Primary	postoperative pain	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	From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively
Secondary	evaluation of opioid-related side effect	Evaluation of opioid-related side effect as nausea, vomiting and pruritus	From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
Secondary	sleep	Subjective sleep score using 11 point numeric rating scale	From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
Secondary	daily activity	Subjective activity score using 11 point numeric rating scale	From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
Secondary	mobility	Daily mobility assessment by attending physiotherapist on 4 point scale	From day of surgery until hospital discharge (approximately 7 days)