PPAPPPAP SpineNCT05367609
Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
A study testing Preoperative Genotyping in people with PPAP and Spine Fusion, run by Senthil Sadhasivam at 5 sites in United States.
Trial summary
The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- PPAP, Spine Fusion
- What is being tested?
- Preoperative Genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Sep 2022to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ages 10 to 21
- ASA physical status 1 to 3
- Undergoing Posterior-Lateral Spinal Fusion
- Receives in-patient opioids
- Prescribed opioids at discharge
Who cannot join
- Serious illness
- Preoperative severe pain
- Preoperative opioid use or misuse
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dayana Alsamsam, BSPS, MSc contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46202
Senthil Packiasabhapathy, MD, sepack@iu.edu
Senthil Packiasabhapathy, MD
- Recruiting
UPMC Children's Hospital
Pittsburgh, Pennsylvania, 15224
Senthilkumar Sadhasivam, MD, MPH, 412-647-2994, sadhasivams@upmc.edu
- Recruiting
University of California
San Francisco, California, 38456
Ridhima Jain, Ridhma.jain@ucsf.edu
Anshuman Sharma
- Not yet recruiting
Children's Orthopaedic and Scoliosis Surgery Associates, LLP
St. Petersburg, Florida, 33701
Ryan E. Fitzgerald, MD, 813-506-5511, rfitzgerald@chortho.com
Priscilla Martinez, 813-506-5511, pmartinez@chortho.com
- Not yet recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Frederick Kuo, MD, 410-929-2123, frederick.kuo@jhmi.edu
Janelle Maddox-Regis, MS, CIP, 443-927-1476, Jmaddox3@jhmi.edu
About this study
The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.
Read the detailed description
Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, and personalizing analgesia.
Aim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posterior spinal fusion (PSF)
- Determine genetic factors predisposing children to immediate and long-term postoperative methadone and oxycodone related adverse effects including RD, PONV, opioid dependence, and CPSP The PI postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and CYP2D6 variants identify children at risk for poor pain relief, RD, PONV, opioid dependence, and CPSP in the postoperative period.
- Determine genetic variants-based perioperative dosing and outpatient prescribing of opioids
The PI hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precision opioid use for optimal clinical outcomes
- Conditions
- PPAP, Spine Fusion
- Being tested
- Preoperative Genotyping
- Keywords
- PPAP, Pediatric, Spine Fusion Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative GenotypingDiagnostic test
Genotype based risk prediction and personalized pain management
| Study group | Role | What they receive |
|---|---|---|
| Children undergoing Spine Fusion Surgery | Other | 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. Receives: Diagnostic Test: Preoperative Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the immediate post-surgical period (4 days) in the hospital
Measured: Immediately post-surgery up to 4 days in patient
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
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the post-surgical period at home up to 1-year
Measured: At home up to 1 year post-surgery
Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.
Measured: Immediately post-surgery
Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the post-surgical period at home up to 1-year. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.
Measured: At home up to 1 year post-surgery
Secondary outcomes (1)
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
The investigators will look at CYP2D6 variants to find correlations in oxycodone's PK sampling and the need for dose adjustments that lead to desired clinical outcomes in children undergoing major inpatient surgeries. Oxycodone will be measured by the IU CTSI's Clinical Pharmacology Analytical Core (CPAC) laboratory using a validated LC/MS/MS as-say,201 and plasma alpha-1 acid glycoprotein (AAG) will be measured using a HPLC/UV assay. Study team will track the subjects choices from their signed consent form regarding PK collections.
Measured: Pre-operative to post-operative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start20 Sep 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPAPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PK sampling and genetic testing will determine the type of analgesia medication treatment the patient receives
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senthil Sadhasivam
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor-investigator, Senthil Sadhasivam, University of Pittsburgh
- Investigators
- Senthilkumar Sadhasivam, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367609
- Sponsor's protocol ID
- STUDY21090075
- Other IDs
- U01TR003719
- Acronym
- PPAP Spine
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current IPD sharing plan anticipated
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
- ClinicalTrials.gov ID
- NCT05367609
- Acronym / sponsor ID
- PPAP Spine / STUDY21090075
- Conditions
- PPAP, Spine Fusion
- Keywords
- PPAP, Pediatric, Spine Fusion Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Senthil SadhasivamUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.
Detailed description
Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, and personalizing analgesia.
Aim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posterior spinal fusion (PSF)
- Determine genetic factors predisposing children to immediate and long-term postoperative methadone and oxycodone related adverse effects including RD, PONV, opioid dependence, and CPSP The PI postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and CYP2D6 variants identify children at risk for poor pain relief, RD, PONV, opioid dependence, and CPSP in the postoperative period.
- Determine genetic variants-based perioperative dosing and outpatient prescribing of opioids
The PI hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precision opioid use for optimal clinical outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PK sampling and genetic testing will determine the type of analgesia medication treatment the patient receives
| Arm | Type | Receives |
|---|---|---|
| Children undergoing Spine Fusion Surgery | Other | Diagnostic Test: Preoperative GenotypingThis 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. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children ages 10 to 21
- ASA physical status 1 to 3
- Undergoing Posterior-Lateral Spinal Fusion
- Receives in-patient opioids
- Prescribed opioids at discharge
Key exclusion criteria (3 listed)
- Serious illness
- Preoperative severe pain
- Preoperative opioid use or misuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative GenotypingGenotype based risk prediction and personalized pain management | Diagnostic test | Children undergoing Spine Fusion Surgery |
Primary outcome
Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
Time frame: Immediately post-surgery up to 4 days in patient
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the immediate post-surgical period (4 days) in the hospital
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
Time frame: At home up to 1 year post-surgery
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience RD and PONV in the post-surgical period at home up to 1-year
Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
Time frame: Immediately post-surgery
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.
Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
Time frame: At home up to 1 year post-surgery
The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with children who experience poor pain relief in the post-surgical period at home up to 1-year. Poor pain relief will be determined using the Numerical Rating Scale (NRS) which runs on a 0-10 scale; 0 being no pain at all, 10 being the worst pain imaginable.
1 secondary outcome
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
Time frame: Pre-operative to post-operative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. No current IPD sharing plan anticipated
Related trials for PPAP
Recruiting
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Cesarean Section Complications, Opioid Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dayana Alsamsam, BSPS, MSc contact
Senthilkumar Sadhasivam, MD, MPH principal investigator
University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Genotyping in people with PPAP and Spine Fusion, run by Senthil Sadhasivam at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senthilkumar Sadhasivam, MD, MPH (4126472994, sadhasivams@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) (time frame: Immediately post-surgery up to 4 days in patient). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.