Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSenthil Sadhasivam
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
Any history of opioid misuse before or during pregnancy-per self-report and clinical notes
Preoperative severe pain and opioid use/misuse, allergy to oxycodone
Allergy to oxycodone
Trial design
Design model
Parallel
Treatments tested in this trial
Preoperative Genotyping
Diagnostic testGenotype based risk prediction and personalized pain management
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Mother undergoing planned Cesarean sectionExperimental treatment 1 intervention
Group B: InfantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Immediately post-surgery during hospital stay2
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
Time frame
At home up to 1 year post-surgery3
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.
Time frame
Immediately post-surgery during hospital stay4
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.
Time frame
At home up to 1 year post-surgerySecondary outcomes
1
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.
Time frame
Pre-operative to post-operative day 2Other outcomes
1
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.
Time frame
Post-operative up to 1-year2
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.
Time frame
Post-operative up to 1-year3
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
Time frame
Post-operative up to 1-yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Senthil Sadhasivam
Lead sponsor
University of Pittsburgh
Sponsor institution
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov