Chronic Postsurgical Pain in Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative
Study Overview
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:
- Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
- Identify predictors for CPSP in children with CP and develop an applicable risk index.
- Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.
Participants will complete:
- Questionnaires/Surveys via email and text message
- In-person Sensory Tests
- In-person Gait and Motion Analysis
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CP diagnosis
- •Have a scheduled lower extremity or spine orthopedic surgery
Exclusion Criteria
- •Non-English speaking and reading parent/guardian
Outcomes
Primary Outcomes
Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative
Time Frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative
The BPI assesses pain location, pain intensity at worst, least, average, and right now as well as the degree to which pain interferes with activities of daily living (e.g., sleep, relationships, and mobility). Items are scored on an 11-point scale (0 = does not interfere, 10 = completely interferes) creating a total interference score ranging from 0-120 (higher scores mean more pain interference). The BPI has been adapted for and tested with individuals with severe CP, resulting in excellent internal consistency (Cronbach's alpha = 0.89) and validity evidence \[1, 29, 30\]. The BPI will take parents/children 1-2 minutes to complete.
Secondary Outcomes
- Gait Outcomes Assessment List (GOAL)(Any time preoperative and 12 months postoperative)
- Dalhousie Pain Interview (DPI)(1 month preoperative, and 1, 3, 6, and 12 months postoperative)
- SNAKE (Schlaffragebogen für Kinder mit Neurologischen und Anderen Komplexen Erkrankungen)Sleep Questionnaire(1 month preoperative, and 1, 3, 6, and 12 months postoperative)
- Numeric Rating Scale (NRS)(From Post-Operative Day (POD) 3-90)
Investigators
Chantel Burkitt
Principal Investigator
Gillette Children's Specialty Healthcare