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Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery

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ClinicalTrials.gov Identifier: NCT04038229
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

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.


Condition or disease Intervention/treatment Phase
Analgesia Scoliosis Idiopathic Surgery Postoperative Pain Other: Enhanced recovery pathway Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
No Intervention: Standard of care
Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis
Experimental: Enhanced recovery pathway
Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038229


Contacts
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Contact: Davina Wildemeersch, MD 038215891 ext +32 davina.wildemeersch@uza.be

Locations
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Belgium
University hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Davina Wildemeersch, MD    003238213042    davina.wildemeersch@uza.be   
Contact: Catheline Spaas, MD       catheline.spaas@uza.be   
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Study Chair: Guy Hans, MD, PhD University Hospital, Antwerp
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Responsible Party: Davina Wildemeersch, Principle investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT04038229    
Other Study ID Numbers: EC19/14/183
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Davina Wildemeersch, University Hospital, Antwerp:
enhanced recovery pathway
analgesia
tele-monitoring
biopsychosocial evaluation
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases