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Clinical Trials/NCT05764681
NCT05764681
Recruiting
Not Applicable

Chronic Postsurgical Pain in Cerebral Palsy

Chantel Burkitt2 sites in 1 country500 target enrollmentMarch 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Chantel Burkitt
Enrollment
500
Locations
2
Primary Endpoint
Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative
Status
Recruiting
Last Updated
7 months ago

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:

  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
Registry
clinicaltrials.gov
Start Date
March 17, 2023
End Date
January 1, 2029
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chantel Burkitt
Responsible Party
Sponsor Investigator
Principal Investigator

Chantel Burkitt

Principal Investigator

Gillette Children's Specialty Healthcare

Eligibility Criteria

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)

Study Sites (2)

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