CPSP: Chronic Postsurgical Pain

Sponsor

Gillette Children's Specialty Healthcare (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05764681

Collaborator

National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), University of Minnesota (Other)

500

Enrollment

Location

70.1

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Chronic Post Surgical Pain

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Chronic Postsurgical Pain in Cerebral Palsy

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2028

Anticipated Study Completion Date :

Jan 1, 2029

Outcome Measures

Primary Outcome Measures

Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative [1 week 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. 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 Outcome Measures

Dalhousie Pain Interview (DPI) [1 week 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), 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.
Numeric Rating Scale (NRS) [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.
Adolescent Pediatric Pain Tool (APPT) [1 week preoperative, and 1, 3, 6, and 12 months postoperative]
When children have pain and are able to self-report they will complete the portion of the APPT that describes pain quality (e.g., burning, itching) and temporal pattern (e.g., how pain changes over time). This information will help inform the type of pain (neuropathic, nociceptive, etc.). The APPT has demonstrated strong psychometric properties in children ages 8-17 years and has been shown to be a valid measure of postoperative pain in children. The APPT will take children 2-3 minutes to complete.
SNAKE Sleep Questionnaire [1 week 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. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CP diagnosis
Have a scheduled lower extremity or spine orthopedic surgery

Exclusion Criteria:

Non-English speaking and reading parent/guardian

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota	United States	55101

Sponsors and Collaborators

Gillette Children's Specialty Healthcare
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Minnesota