Understanding how ketamine works for pain and depression after cesarean delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting
• Magee Womens Hospital of UPMC
  Pittsburgh, Pennsylvania, United States Terminated

Study contacts

• Principal investigator: Grace Lim, MD, MSc — University of Utah
• Study coordinator: Natalie Bennion, MPH
• Email: natalie.bennion@utah.edu
• Phone: 385-209-1185

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.