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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01TR003719-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this collaborative CTSA (Clinical and Translational Science Award) 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 breastfeeding mothers and their infants
The approach includes 1) development and implementation of an innovative PPAP infrastructure at participating CTSA hubs (Aim 1) and 2) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids and precision dosing in nursing mothers and infants (Aim 2).
SPECIFIC AIMS: 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
Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, Clinical Pharmacogenetics Implementation (CPIC) guidelines, precision dosing, clinical safety, and personalizing analgesia
Aim 2. Evaluate utility of PPAP in nursing mothers and their newborns following Cesarean Section The investigators hypothesize that CYP2D6 and other (ABCB1, and OPRM1) variants will explain clinical and pharmacokinetic variations of oxycodone, and PPAP implementation will reduce adverse effects in mothers and infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother undergoing planned Cesarean section | Experimental | Mother subject will have genotyping blood draw performed at the time of controlled delivery (CD). Blood samples and breast milk samples will also be taken during the oxycodone dosing schedule. |
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| Infant | Experimental | Infant subject will have genotyping blood draw performed only at the time of controlled delivery (CD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Genotyping | Diagnostic Test | Genotype based risk prediction and personalized pain management |
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| Measure | Description | Time Frame |
|---|---|---|
| Look at genetic factors predisposing patients 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 patients who experience RD and PONV in the immediate post-surgical period (4 days) in the hospital | Immediately post-surgery during hospital stay |
| Look at genetic factors predisposing patients 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 patients who experience RD and PONV in the post-surgical period at home up to 1-year | At home up to 1 year post-surgery |
| Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone | The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with patients who experience poor pain relief in the immediate post-surgical period (4 days) in the hospital. Poor pain relief will be measured 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. | Immediately post-surgery during hospital stay |
| Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone | The investigators will look at specific CYP2D6, ABCB1, FAAH, OPRM1, and COMT variants to find correlations with patients who experience poor pain relief in the post-surgical period at home up to 1-year. Poor pain relief will be measured 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. | At home up to 1 year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in patients 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 women undergoing a cesarean section and their infant. | Pre-operative to post-operative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Patients will be asked to complete psychological questionnaires post-surgery to assess psycho-psychological factors that may correlate with CPSP. CPSP is defined as pain that develops after a surgical procedure and lasts at least 3 months and significantly affects health-related quality of life. |
Inclusion Criteria:
Adult women (>18 yr) All races American Society of Anesthesiologists Classification (ASA) physical status: 1 to 3 undergoing elective Cesarean section that are willing to receive in-patient opioids.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senthilkumar Sadhasivam, MD, MPH | Contact | 4126472994 | sadhasivams@upmc.edu | |
| Dayana Alsamsam, MPH | Contact | alsamsamd@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Senthilkumar Sadhasivam, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Children's Hospital- Clinics / Labor and Delivery Unit | Recruiting | Indianapolis | Indiana | 46202 | United States |
No current IPD sharing plan anticipated
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Interventional study with mother undergoing elective c-section and the infant
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| Post-operative up to 1-year |
| Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery | Patients will be asked to complete psychological questionnaires post-surgery to assess psycho-psychological factors that may correlate with opioid dependence (OD). OD will be determined using the validated Sophia Observation Withdrawal Symptoms Scale (SOS). The SOS is based on a 15-point scale. | Post-operative up to 1-year |
| Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery | Patients will be asked to complete psychological questionnaires post-surgery to assess psycho-psychological factors that may correlate with opioid dependence (OD). OD will be determined using the Clinical Opiate Withdrawal Scale (COWS). The COWS is based on a scale with a minimum score of 5 and maximum score of 48; 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal | Post-operative up to 1-year |
| Washington University Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
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| UPMC Magee Women's Hospital | Not yet recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15260 | United States |
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