The Adolescent Surgery Experience: A Mixed Methods Analysis

NCT ID: NCT05482919

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 501 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2023-10-15

Brief Summary

New chronic pain and opioid use are reported as prevalent among adolescents undergoing major surgery; many unanswered questions remain regarding recovery and the anticipated pain trajectory across procedures and the interaction between pain treatment, acute inflammation and new chronic pain. Broadly, the proposed study will characterize the adolescent's postoperative recovery experience, and establish the anticipated pain trajectory across a range of procedures.

Detailed Description

The proposed study will characterize the adolescent's postoperative pain and recovery experience. Using a mixed methods design, Investigators will follow a diverse cohort of up to 500 adolescents undergoing surgery at the Children's Hospital of Philadelphia (CHOP) over six months to systematically characterize their recovery trajectory. The primary objective is to characterize development of new chronic pain in the context of longitudinal pain trajectories among adolescents in the first 6 months after surgery and to quantify implications of post-surgical pain and pain treatment. The secondary objectives are to determine factors associated with prolonged opioid use after surgery compared to peers (measured in days to discontinuation) and to characterize factors associated with delayed recovery from surgery compared to peers. A baseline survey, including an anxiety and depression screen using the Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) surveys will be collected after consent and prior to surgery; subsequent post-operative surveys will be collected at one & two weeks, one month, then monthly up to 6 months with total of 8 surveys. The PHQ-9 and GAD-7 will also be administered on month 1, month 3, and month 5. A subgroup of patients will be invited to complete a qualitative interview one month and three months after surgery (+/- 14 days). Adolescents may participate in the 3-month interview if they did not participate in the 1-month interview. The team will select adolescents who report higher pain scores compared to peers undergoing similar procedures on the Weeks 1, 2 and 3 month surveys and a sample of adolescents who are recovering as anticipated. Interviews will take place via telephone or CHOP approved videoconferencing platform with transcription and transcripts, entered in REDCap, that only contain the patient's study identification (ID) as a personal identifier. It is anticipated that some adolescents will decline participation in the one-month survey; they will not be approached to participate in the three-month survey unless they indicate willingness to receive an invitation upon submitting the Month 3 survey. It is also anticipated that individuals may decline to participate in the three-month survey and Investigators will plan to extend additional invitations to complete approximately 25 interviews at each interval.

Conditions

Pain, Postoperative; Pain; Pain, Acute; Pain, Chronic; Adolescent Behavior; Opioid Use

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Baseline Survey

The baseline survey, initial PHQ-9 and GAD-7, could be collected prior to surgery after consent, or on the day of surgery, for participants who are undergoing elective surgery or urgent procedures and did not attend pre-operative clinic. Demographic information such as race and ethnicity, pain medications and pain history and baseline self-reported health information will be collected. It will take about 15 minutes to complete.

Intervention Type: BEHAVIORAL

Post Operative Surveys

Post operative surveys will be collected at one week, two weeks, one month, then monthly up to 6 months after surgery with total of 7 post-op surveys. Refer to Table 1 for visit windows. The study survey could be collected by phone, REDCap texting or email per the subject's preference. Survey content will also include: daily average and maximum self-reported pain scores on a 0-10 Numeric Rating Scale (NRS) pain scale, average hours of sleep, anxiety and depression screens using the PHQ-9 and GAD-7 questionnaires (Months 1, 3, and 5), pain location and quality, percentage of day spent in pain, satisfaction with recovery using a five-point Likert scale, and type, quantity and timing of any medications used for pain (including opioid alternatives).

Intervention Type: BEHAVIORAL

Qualitative Interviews

Using sampling to identify adolescents who exhibit higher pain scores or prolonged opioid use compared to peers after completion of the first three surveys (pre-operative, Week 1, Week 2), the study will also select a representative sample of adolescents who are recovering as anticipated. Examples of delayed recovery include a higher proportion of moderate to severe pain scores, dissatisfaction with recovery and prolonged opioid use compared to peers. As a balancing measure, the upper limit of adolescents who are perceived to exhibit delayed recovery that are approached for interviews will be capped at a 3:1 ratio compared to those who are recovering as anticipated, and Investigators will prioritize an equal demographic distribution among the two groups. Interviews will take place over the phone or through a CHOP approved vendor at 1 and 3 months after surgery; audio will be recorded with participant consent.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Males or females age 11 to 21 years

2. Scheduled for non-cardiac surgery at one of five CHOP surgical centers

3. American Society of Anesthesiologists Physical Status (ASA) ≤ 3

4. Girls 11 years of age and older must have a negative urine/serum pregnancy test

5. Parental/guardian permission (informed consent) if participant <18 years old and if appropriate, child assent

Exclusion Criteria

1. Subjects with limited English proficiency.

2. History of chronic pain

3. History of prior opioid use >5 consecutive days for acute pain or >10 consecutive days for major surgery in their life time

4. Pregnant or lactating females

5. Subjects who, in the opinion of the investigator, may be non-compliant with study schedules.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tori N Sutherland, MD MPH

Role: PRINCIPAL_INVESTIGATOR

CHOP

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

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Other Identifiers

22-019982

Identifier Type: -

Identifier Source: org_study_id