Chronic Postsurgical Pain

NCT05764681 | Recruiting

• 2 other identifiers: STUDY000146681R01HD108406-01A1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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. 1.Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
2. 2.Identify predictors for CPSP in children with CP and develop an applicable risk index.
3. 3.Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.
4. 4.Questionnaires/Surveys via email and text message
5. 5.In-person Sensory Tests
6. 6.In-person Gait and Motion Analysis

Conditions

Cerebral Palsy; Chronic Post Surgical Pain

Keywords

Cerebral Palsy; Pain; Chronic Pain; Post Surgical Pain; Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 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.

  1 month preoperative, and 1, 3, 6, and 12 months postoperative

Secondary Outcomes (4)

• Dalhousie Pain Interview (DPI)

  1 month preoperative, and 1, 3, 6, and 12 months postoperative

• Numeric Rating Scale (NRS)

  From Post-Operative Day (POD) 3-90

• SNAKE (Schlaffragebogen für Kinder mit Neurologischen und Anderen Komplexen Erkrankungen)Sleep Questionnaire

  1 month preoperative, and 1, 3, 6, and 12 months postoperative

• Gait Outcomes Assessment List (GOAL)

  Any time preoperative and 12 months postoperative

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• Non-English speaking and reading parent/guardian

Sponsors & Collaborators

• Chantel Burkitt: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Minnesota: collaborator
• Nemours Children's Hospital: collaborator

Study Sites (2)

Nemour's Children's Hospital

Wilmington, Delaware, 19803, United States

RECRUITING

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Cerebral Palsy; Pain, Postoperative; Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Chantel Burkitt, PhD

  Gillette Children's, University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maykala Owens

CONTACT

6512291717; maykalajowens@gillettechildrens.com

Lisa Lykken

CONTACT

6512291768; LisaALykken@gillettechildrens.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 13, 2023
• Study Start: March 17, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)