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Personalized Pain Management for Spinal Fusion (PPAP Spine Trial)

N/A

Recruiting

Led By Senthilkumar Sadhasivam, MD, MPH

Research Sponsored by Senthilkumar Sadhasivam

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prescribed opioids at discharge

Children ages 10 to 17.9

Must not have

Preoperative severe pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative up to 1-year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to give pain medicine to kids during surgery, with the hope of reducing serious side effects from opioids.

Who is the study for?

This trial is for children aged 10 to nearly 18, in good to moderate health (ASA status 1-3), who will need opioids during and after a specific back surgery called Posterior-Lateral Spinal Fusion. They can't join if they have serious illnesses, already suffer from severe pain before the operation, or use/misuse opioids beforehand.

What is being tested?

The study is developing a personalized pain management system for kids having spine fusion surgery. It involves preoperative genotyping—testing their genes—to tailor pain treatment and minimize opioid-related risks.

What are the potential side effects?

Since this trial focuses on personalizing anesthesia based on genetic testing rather than new medications, side effects may be more related to standard opioid use such as nausea, constipation, drowsiness or risk of dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was prescribed opioids when I was discharged.

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I am between 10 and 17 years old.

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I am currently receiving opioids in a hospital.

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I am scheduled for or have had a Posterior-Lateral Spinal Fusion surgery.

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My health is good to moderately impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience severe pain before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative up to 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative up to 1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative up to 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)

Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone

Look at genetic factors predisposing children to postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) at genetic factors predisposing children to inadequate surgical pain relief with oxycodone

Secondary study objectives

Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in children to see if specific variants correlate with a need for lower or higher doses of analgesic

Other study objectives

Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with chronic persistent surgical pain (CPSP) up to 1-year post-surgery

Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Children undergoing Spine Fusion SurgeryExperimental Treatment1 Intervention

This arm will include approximately 300 children undergoing spine fusion surgery 1. Pharmacokinetic (PK): collection of 10-13 serial blood samples to determine serum levels of methadone/oxycodone and its metabolites 2. Pharmacogenetic (PG): Preoperative CYP2D6 genotyping (for preferential recruitment of CYP2D6 PMs and UMs). This will be collected in the pre-operative clinic via blood if there are clinical labs needed for standard of care. If no blood is needed in the pre-op clinic, the investigators will collect this via saliva. Postoperative Analgesia Dose and PK Sampling Schedule: Clinical care providers are blinded to CYP2D6/CYP2B6 when prescribing oxycodone/methadone; and genetic analysis of proposed targeted genes. Results of these samples will be used to determine personalized analgesia plan.

0 / 6Eligibility criteria met