Clinical trial NCT05764681: Chronic Postsurgical Pain
Official title: Chronic Postsurgical Pain in Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Chronic Post Surgical Pain
Keywords: Cerebral Palsy
Pain
Chronic Pain
Post Surgical Pain
Orthopedic Surgery
Lead sponsor: Gillette Children's Specialty Healthcare
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Minnesota
name: Nemours Children's Hospital
First posted: 2023-03-13
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Cerebral Palsy undergoing an orthopedic surgery at Gillette Children's Specialty Healthcare or Nemour's Children Hospital, Delaware

Brief summary: The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to:

1. Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
2. Identify predictors for CPSP in children with CP and develop an applicable risk index.
3. Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.

Participants will complete:

1. Questionnaires/Surveys via email and text message
2. In-person Sensory Tests
3. In-person Gait and Motion Analysis


Eligibility criteria: Inclusion Criteria:

* CP diagnosis
* Have a scheduled lower extremity or spine orthopedic surgery

Exclusion Criteria:

* Non-English speaking and reading parent/guardian

Primary outcomes:
measure: Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative
timeFrame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative
Secondary outcomes:
measure: Dalhousie Pain Interview (DPI)
timeFrame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative
measure: Numeric Rating Scale (NRS)
timeFrame: From Post-Operative Day (POD) 3-90
measure: SNAKE (Schlaffragebogen für Kinder mit Neurologischen und Anderen Komplexen Erkrankungen)Sleep Questionnaire
timeFrame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative
measure: Gait Outcomes Assessment List (GOAL)
timeFrame: Any time preoperative and 12 months postoperative
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemour's Children's Hospital
state: Delaware
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: Gillette Children's, University of Minnesota
name: Chantel Burkitt, PhD
role: PRINCIPAL_INVESTIGATOR
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