Clinical trial NCT05482919: The Adolescent Surgery Experience: A Mixed Methods Analysis
Official title: The Adolescent Surgery Experience: A Mixed Methods Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Pain
Pain, Acute
Pain, Chronic
Adolescent Behavior
Opioid Use
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 501
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll up to 500 adolescents age 11-21 years undergoing surgery at all CHOP surgical sites

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.

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.

Primary outcomes:
measure: Incidence of new chronic pain
timeFrame: 7 months
Secondary outcomes:
measure: Prolonged opioid use compared to peers undergoing similar surgeries
timeFrame: 7 months
measure: Delayed recovery compared to peers
timeFrame: 7 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: CHOP
name: Tori N Sutherland, MD MPH
role: PRINCIPAL_INVESTIGATOR
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