← Back to Search

Clinical Decision Support

Genotype-Guided Pain Management for Acute Pain (ADOPT PGx Trial)

N/A
Waitlist Available
Led By Hrishikesh Chakraborty
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 8 years
Undergoing a laparoscopic surgery
Must not have
Are too cognitively impaired to provide informed consent and/or complete study protocol
Have a history of allogeneic stem cell transplant or liver transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months post-surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial studies whether testing & genotype-guided pain management improves pain after surgery for people whose bodies process some pain meds differently.

Who is the study for?
This trial is for English or Spanish speakers aged 8 years and older who are planning to have elective surgeries like orthopedic, abdominal, or cardiothoracic surgery and expect to manage pain with certain opioids. It's not for those on chronic opioid therapy, with a life expectancy under 12 months, cognitive impairments preventing consent, institutionalization, history of certain transplants, or prior relevant pharmacogenetic tests.
What is being tested?
The Acute Pain Trial compares immediate pharmacogenetic testing and tailored post-surgery opioid therapy against standard care with delayed testing. The goal is to see if personalized pain management based on genetic testing can improve pain control in patients slow at processing some pain medicines.
What are the potential side effects?
While the trial primarily focuses on effectiveness rather than side effects, potential risks may include issues related to the surgical procedure itself and reactions from genotype-guided opioid therapy which could range from mild discomfort to more serious medication-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 8 years old or older.
Select...
I am scheduled for a minimally invasive surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand or follow the study's procedures due to cognitive issues.
Select...
I have had a stem cell or liver transplant from a donor.
Select...
I am not institutionalized, too ill, or incarcerated to participate.
Select...
I have been taking opioids almost daily for more than 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
10 Day SIA Score Change from Baseline
Secondary study objectives
1 Month Mobility Score Change from Baseline
10 Day Pain Intensity Change from Baseline
3 Month Prescription Pain Medication Misuse Change from Baseline
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Acute Pain - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Group II: Acute Pain - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period

Find a Location

Who is running the clinical trial?

University of FloridaOTHER
1,409 Previous Clinical Trials
765,621 Total Patients Enrolled
2 Trials studying Acute Pain
30 Patients Enrolled for Acute Pain
Vanderbilt University Medical CenterOTHER
908 Previous Clinical Trials
933,238 Total Patients Enrolled
1 Trials studying Acute Pain
290 Patients Enrolled for Acute Pain
Indiana University School of MedicineOTHER
192 Previous Clinical Trials
177,805 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
914 Previous Clinical Trials
569,277 Total Patients Enrolled
National Human Genome Research Institute (NHGRI)NIH
270 Previous Clinical Trials
292,467 Total Patients Enrolled
Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,979,945 Total Patients Enrolled
8 Trials studying Acute Pain
6,742 Patients Enrolled for Acute Pain
Hrishikesh ChakrabortyPrincipal InvestigatorDuke University
4 Previous Clinical Trials
13,374 Total Patients Enrolled
1 Trials studying Acute Pain
4,111 Patients Enrolled for Acute Pain

Media Library

Clinical decision support (Clinical Decision Support) Clinical Trial Eligibility Overview. Trial Name: NCT05966129 — N/A
Acute Pain Research Study Groups: Acute Pain - Immediate PGx Testing, Acute Pain - Delayed PGx Testing
Acute Pain Clinical Trial 2023: Clinical decision support Highlights & Side Effects. Trial Name: NCT05966129 — N/A
Clinical decision support (Clinical Decision Support) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05966129 — N/A
~337 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top