The Adolescent Surgery Experience: A Mixed Methods Analysis

September 24, 2024 updated by: Children's Hospital of Philadelphia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

501

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

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

11 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

N/A

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

Description

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 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of new chronic pain
Time Frame: 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.
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged opioid use compared to peers undergoing similar surgeries
Time Frame: 7 months
Factors associated with prolonged opioid use after surgery, measured in time to opioid discontinuation after surgery, compared to peers undergoing similar surgeries
7 months
Delayed recovery compared to peers
Time Frame: 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.
7 months

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Tori N Sutherland, MD MPH, CHOP

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)

June 14, 2022

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

October 15, 2023

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-019982

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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