The Adolescent Surgery Experience: A Mixed Methods Analysis

Completed

• Conditions: Pain; Adolescent Behavior; Pain, Acute; Opioid Use; Pain, Chronic; Pain, Postoperative

• Registration Number: NCT05482919
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study Start: 2022-06-14
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Status Verified: 2023-09
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-15
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of new chronic pain	7 months	Incidence of new chronic pain, using the International Association for the Study of Pain (IASP) definition at 3 months after surgery, among a diverse cohort of adolescents undergoing major surgery. Prior reports in the adolescent surgery literature have suggested that 20% of patients develop chronic pain, defined as surgical site pain that persists more than three months after surgery. Here, Investigators have hypothesized that a lower chronic pain incidence of 11% exists among adolescents at CHOP after undergoing major surgery. Therefore using a two-sided Wald test to detect a significant difference from historic estimates, Investigators will enroll a minimum of 115 patients undergoing major surgery (a=0.05; b=0.1; n=95, assuming conservative 20% loss of follow-up). The remainder of the up to 500 subjects will represent a variety of procedures associated with mild, moderate and severe postoperative pain to characterize recovery trajectories.

Secondary Outcome Measures

Name	Time	Method
Prolonged opioid use compared to peers undergoing similar surgeries	7 months	Factors associated with prolonged opioid use after surgery, measured in time to opioid discontinuation after surgery, compared to peers undergoing similar surgeries
Delayed recovery compared to peers	7 months	Factors, including elevated average and maximum NRS scores, GAD-7 and PHQ-9 scores, and Screening to Brief Intervention (S2BI) scores, associated with delayed recovery from surgery compared to peers undergoing similar surgeries. For the NRS scale, which ranges from 0-10, a response of '0' corresponds to "no pain" while a response of '10' corresponds to extreme severe pain (e.g., "worst pain imaginable"). For the GAD-7 scale, a score of 5-9 corresponds to mild anxiety, 10-14 to moderate anxiety and 15+ to severe anxiety. For the PHQ-9 scale, 4 or more items selected in the shaded section corresponds to a possible depressive disorder with 5 or more corresponding to a possible major depressive disorder. For the S2BI scale, a never response corresponds to no reported substance use, once or twice corresponds to lower risk substance use and more than monthly corresponds to higher risk substance use.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States