Chronic Postsurgical Pain (CPSP)

January 12, 2024 updated by: Chantel Burkitt

Chronic Postsurgical Pain in Cerebral Palsy

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemour's Children's Hospital
        • Contact:
        • Principal Investigator:
          • Wade Shrader, MD
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Gillette Children's Specialty Healthcare
        • Principal Investigator:
          • Chantel Burkitt, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking and reading parent/guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month preoperative, and 1, 3, 6, and 12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: From Post-Operative Day (POD) 3-90
The NRS of pain is considered the 'gold standard' and has been widely used to quantify pain intensity (0-10 scale; 0=no pain, 10=worst possible pain). We will use the NRS specific to head, shoulders, upper arm, elbow, forearm, wrist/hand, back, hip, upper leg, knee, lower leg, ankle, and foot pain. The NRS will complement the DPI since it is joint-specific, which is a critical element to capture when assessing orthopedic outcomes. The NRS will take parents/children 3 minutes to complete.
From Post-Operative Day (POD) 3-90
Dalhousie Pain Interview (DPI)
Time Frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative
The DPI uses a 10-item survey to quantify pain intensity (Primary outcome variable; scored 0-10 with higher scores indicating more pain), duration (minutes/seconds in pain), and pain frequency (number of pain episodes) for each type of pain reported in the last week. The type and dose of pain-related medications is also collected. The DPI was developed to assess acute and chronic pain in children with developmental disabilities. The investigative team has considerable experience with the DPI and pain parameters have shown sensitivity to change after treatment [30, 31]. The DPI will take parents/children 5-15 minutes to complete.
1 month preoperative, and 1, 3, 6, and 12 months postoperative
SNAKE (Schlaffragebogen für Kinder mit Neurologischen und Anderen Komplexen Erkrankungen)Sleep Questionnaire
Time Frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative
We will also collect the SNAKE Sleep Questionnaire via parent-report, a 43-item tool that measures the sleep environment, sleep patterns, and sleep behaviors (scores ranging from 23-92 with higher scores indicating more sleep difficulties). This tool was designed specifically for individuals with severe disabilities, and individuals with CP were included in the validation sample. The SNAKE will take parents 2-5 minutes to complete.
1 month preoperative, and 1, 3, 6, and 12 months postoperative
Gait Outcomes Assessment List (GOAL)
Time Frame: Any time preoperative and 12 months postoperative
The GOAL had initial data published on it in 2011 [33]. It was developed for individuals with ambulatory CP and their parents as a comprehensive assessment of gait-related function. It is an outcome tool that incorporates all domains of the International Classification of Functioning, Disability and Health, including the influence of environment and personal factors [34].It contains 7 different domains and scores for each domain and for the total survey are standardized and range from 0 (worst) to 100 (best). A novel component of the GOAL is that it also incorporates the family's priorities for treatment.
Any time preoperative and 12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chantel Burkitt

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
University of Minnesota
Nemours Children's Hospital, Delaware

Investigators

  • Principal Investigator: Chantel Burkitt, PhD, Gillette Children's, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00014668
  • 1R01HD108406-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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