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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative up to 1-year

Awards & highlights

PPAP Spine Trial 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.Check my eligibility

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.See study design

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.

PPAP Spine Trial 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.

PPAP Spine Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

PPAP Spine 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 Pharmacokinetic (PK): collection of 10-13 serial blood samples to determine serum levels of methadone/oxycodone and its metabolites 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 / 5Eligibility criteria met

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Who is running the clinical trial?

Senthilkumar SadhasivamLead Sponsor

4 Previous Clinical Trials

2,600 Total Patients Enrolled

Senthil SadhasivamLead Sponsor

4 Previous Clinical Trials

2,600 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,430 Total Patients Enrolled

Media Library

Personalized Perioperative Analgesia Platform (PPAP) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05367609 — N/A

Spinal Fusion Research Study Groups: Children undergoing Spine Fusion Surgery

Spinal Fusion Clinical Trial 2023: Personalized Perioperative Analgesia Platform (PPAP) Highlights & Side Effects. Trial Name: NCT05367609 — N/A

Personalized Perioperative Analgesia Platform (PPAP) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05367609 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted for this research endeavor?

"Affirmative. Clinicaltrials.gov confirms that this medical investigation, which began on September 1st of 2022, is seeking participants. This clinical trial demands 300 individuals from two separate sites for enrolment eligibility."

Answered by AI

Who is best suited for involvement with this medical experiment?

"This medical study is searching for up to 300 patients between the ages of 10 and 17, who meet the following criteria: pediatric age range (10-17.9), American Society of Anesthesiologists physical status 1 through 3, scheduled for a posterior-lateral spinal fusion procedure, inpatient opioid use prior to recruitment and a prescription for opioids upon completion of treatment."

Answered by AI

Does this experiment accept volunteers who are elderly?

"The research team specified that all participants in this trial must be between 10 and 17 years old. For those under 18, there are 5 studies available; meanwhile, seniors aged 65 or above can opt for one of 29 different trials."

Answered by AI

What is the aggregate population participating in this research endeavor?

"Affirmative. According to the information on clinicaltrials.gov, enrollment for this investigation began in September of 2022 and is still ongoing as of October 7th 2022. This endeavor requires 300 participants from 2 different medical centers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)

Senthil Sadhasivam 2022. "Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05367609.

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