Understanding how ketamine works for pain and depression after cesarean delivery
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
This study is testing how ketamine can help manage pain and depression in new mothers after a cesarean delivery compared to healthy men and women who are not pregnant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT06767566 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics and pharmacodynamics of ketamine in postpartum women who have undergone cesarean delivery. Participants will receive a ketamine infusion for 12 hours after delivery, and their responses will be compared to healthy non-pregnant female and male controls receiving the same treatment. The study aims to fill knowledge gaps regarding ketamine's effects in the postpartum period and explore potential sex differences in its metabolism. By understanding these dynamics, the study seeks to improve pain management and reduce depressive symptoms in new mothers.
Who should consider this trial
Good fit: Ideal candidates include postpartum women aged 18 and older who are undergoing cesarean delivery and meet specific health criteria.
Not a fit: Patients with contraindications to ketamine or those undergoing general anesthesia for cesarean delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and reduced postpartum depression for women after cesarean delivery.
How similar studies have performed: While there is limited data on ketamine's use in postpartum settings, similar studies have shown promising results in pain management and depression treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Peripartum Participants: Inclusion Criteria * Cesarean delivery * Adults 18 years and older * Term delivery ≥ 37 weeks gestation anticipated at time of delivery * ASA PS 2 or 3 * Able to provide informed consent * One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan. Exclusion Criteria * Patient going under general anesthesia for cesarean delivery * Allergy to study medication (ketamine) * ASA PS 4 + * Contraindications to neuraxial anesthesia * Preterm delivery (\<37 weeks gestation) * Anticipated fetal-neonatal complex care plan as indicated in the patient's chart * Patient history of ketamine or PCP abuse * Patient history of schizophrenia or psychosis * Patient history of liver or renal insufficiency * Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine * Participating in another pain or depression intervention trial * Undergoing hormonal or gender affirming therapies * Pre-eclampsia with severe features * Hemodynamic instability * Inability to participate in study procedures for any reason * Contraindicated medications use: oral antihypertensive medications (exclusion: hypertensive disorders of pregnancy), intravenous magnesium (exclusion: pre-eclampsia with severe features), ketamine/phencyclidine/psilocybins/any other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine/other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis) Control Participants Inclusion Criteria * Age 18 years and older * Sex: Male or Female * Able to provide informed consent * ASA PS 1, 2, or 3 Exclusion Criteria * Allergy to study medication (ketamine) * ASA PS 4 + * Inability to participate in study procedures for any reason * Patient history of ketamine or PCP abuse * Patient history of schizophrenia or psychosis * Patient history of liver or renal insufficiency * Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine * Participating in another pain or depression intervention trial * Hemodynamic instability * Pregnant or pregnant within the last 6 weeks * Unwilling to provide urine sample for pregnancy testing (female controls) * Undergoing hormonal or gender affirming therapies * Contraindicated medications use: ketamine, phencyclidine, psilocybins, or other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine, or other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC Montefiore Clinical and Translational Research Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Grace Lim, MD, MSc — University of Pittsburgh
- Study coordinator: Amy Monroe, MPH, MBA
- Email: monroeal@upmc.edu
- Phone: 4126236382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.