The Adolescent Surgery Experience: A Mixed Methods Analysis

Pain Clinical Trial

Official title:

The Adolescent Surgery Experience: A Mixed Methods Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05482919
• Other study ID #: 22-019982
• Status: Completed
• Start date: June 14, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: September 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: October 15, 2023
• Est. primary completion date: October 11, 2023
• Gender: All
• Age group: 11 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Harbaugh CM, Lee JS, Chua KP, Kenney B, Iwashyna TJ, Englesbe MJ, Brummett CM, Bohnert AS, Waljee JF. Association Between Long-term Opioid Use in Family Members and Persistent Opioid Use After Surgery Among Adolescents and Young Adults. JAMA Surg. 2019 Apr 1;154(4):e185838. doi: 10.1001/jamasurg.2018.5838. Epub 2019 Apr 17. — View Citation

Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4. — View Citation

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Kelley-Quon LI, Kirkpatrick MG, Ricca RL, Baird R, Harbaugh CM, Brady A, Garrett P, Wills H, Argo J, Diefenbach KA, Henry MCW, Sola JE, Mahdi EM, Goldin AB, St Peter SD, Downard CD, Azarow KS, Shields T, Kim E. Guidelines for Opioid Prescribing in Children and Adolescents After Surgery: An Expert Panel Opinion. JAMA Surg. 2021 Jan 1;156(1):76-90. doi: 10.1001/jamasurg.2020.5045. Erratum In: JAMA Surg. 2021 Apr 1;156(4):403. — View Citation

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Page MG, Campbell F, Isaac L, Stinson J, Katz J. Parental risk factors for the development of pediatric acute and chronic postsurgical pain: a longitudinal study. J Pain Res. 2013 Sep 30;6:727-41. doi: 10.2147/JPR.S51055. eCollection 2013. — View Citation

Page MG, Stinson J, Campbell F, Isaac L, Katz J. Identification of pain-related psychological risk factors for the development and maintenance of pediatric chronic postsurgical pain. J Pain Res. 2013;6:167-80. doi: 10.2147/JPR.S40846. Epub 2013 Mar 5. — View Citation

Rabbitts JA, Aaron RV, Fisher E, Lang EA, Bridgwater C, Tai GG, Palermo TM. Long-Term Pain and Recovery After Major Pediatric Surgery: A Qualitative Study With Teens, Parents, and Perioperative Care Providers. J Pain. 2017 Jul;18(7):778-786. doi: 10.1016/j.jpain.2017.02.423. Epub 2017 Feb 21. — View Citation

Rabbitts JA, Fisher E, Rosenbloom BN, Palermo TM. Prevalence and Predictors of Chronic Postsurgical Pain in Children: A Systematic Review and Meta-Analysis. J Pain. 2017 Jun;18(6):605-614. doi: 10.1016/j.jpain.2017.03.007. Epub 2017 Mar 29. — View Citation

Rabbitts JA, Groenewald CB. Epidemiology of Pediatric Surgery in the United States. Paediatr Anaesth. 2020 Oct;30(10):1083-1090. doi: 10.1111/pan.13993. Epub 2020 Aug 29. — View Citation

Rabbitts JA, Kain Z. Perioperative Care for Adolescents Undergoing Major Surgery: A Biopsychosocial Conceptual Framework. Anesth Analg. 2019 Oct;129(4):1181-1184. doi: 10.1213/ANE.0000000000004048. No abstract available. — View Citation

Rabbitts JA, Palermo TM, Zhou C, Mangione-Smith R. Pain and Health-Related Quality of Life After Pediatric Inpatient Surgery. J Pain. 2015 Dec;16(12):1334-1341. doi: 10.1016/j.jpain.2015.09.005. Epub 2015 Sep 28. — View Citation

Rabbitts JA, Palermo TM, Zhou C, Meyyappan A, Chen L. Psychosocial Predictors of Acute and Chronic Pain in Adolescents Undergoing Major Musculoskeletal Surgery. J Pain. 2020 Nov-Dec;21(11-12):1236-1246. doi: 10.1016/j.jpain.2020.02.004. Epub 2020 Jun 15. — View Citation

Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281. — View Citation

Sieberg CB, Simons LE, Edelstein MR, DeAngelis MR, Pielech M, Sethna N, Hresko MT. Pain prevalence and trajectories following pediatric spinal fusion surgery. J Pain. 2013 Dec;14(12):1694-702. doi: 10.1016/j.jpain.2013.09.005. — View Citation

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Ward A, Jani T, De Souza E, Scheinker D, Bambos N, Anderson TA. Prediction of Prolonged Opioid Use After Surgery in Adolescents: Insights From Machine Learning. Anesth Analg. 2021 Aug 1;133(2):304-313. doi: 10.1213/ANE.0000000000005527. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of new chronic pain	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	Prolonged opioid use compared to peers undergoing similar surgeries	Factors associated with prolonged opioid use after surgery, measured in time to opioid discontinuation after surgery, compared to peers undergoing similar surgeries	7 months
Secondary	Delayed recovery compared to peers	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