CompletedPhase 2

Ketamine to Improve Recovery After Cesarean Delivery - Part 1

United States8 participantsStarted 2019-10-09

Plain-language summary

The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk transfer of ketamine and its metabolites will be assessed. Additionally calculated estimations for neonatal and infant exposure will be assessed. In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include postpartum pain, depression scores, central sensitization measures, patient-reported postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute post-cesarean period and up to 12 weeks postpartum in a randomized controlled trial.

Who can participate

Age range

18 Years – 99 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult female patients (i.e., ≥18 years of age) and able to provide informed consent * Cesarean Delivery, Scheduled or Non-Emergent (delivery within 15 minutes not necessary), or female weaning off of breastfeeding * Cesarean cohort: ASA PS 2 or 3, with or without E designation (delivery within 15 minutes not necessary), Scheduled or Non-Emergent * Spinal anesthesia with intrathecal morphine if Cesarean Delivery, Scheduled or Non-Emergent * Multimodal postop analgesia with IV ketorolac, PO NSAID, and PO APAP if Cesarean Delivery, Scheduled or Non-Emergent * Women who do not plan to breastfeed or who want to temporarily withhold breastfeeding or who are weaning off of breastfeeding (Part 1) Exclusion Criteria: * Cesarean Delivery under General Anesthesia * Allergies to study medications * ASA PS 4 or 4E * ASA PS with E designation because delivery within 15 minutes required * ASA PS greater than 4 (moribund patients) * Contraindications to spinal anesthesia * Contraindications to NSAIDs (gastric bypass, etc.) * Contraindication to any other multimodal analgesia medicine * Significant psychiatric history (depression and anxiety NOT exclusion criteria), uncontrolled hyperthyroidism, cardiac disease, fever, hypertension * Adverse occurrence during caesarean section such as hemorrhage, need for transfusion, hemodynamic instability * Placenta accreta spectrum or previa with large anticipated blood loss * History of hallucinations, alcohol or illicit substanc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ketamine (AUC)

Timeframe: 12 hour ketamine infusion

Steady State (Css)

Timeframe: 12 hours after ketamine infusion start

Elimination Half Life (T1/2) for Ketamine

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Volume of Distribution Steady State (Vdss)

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Ketamine Milk to Plasma Ratio (M:P)

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Nor-ketamine Milk to Plasma Ratio

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Hydroxynorketamine M:P Ratio

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Trial details

NCT IDNCT04037085

SponsorGrace Lim, MD, MS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-01

Results submitted2022-09-30

View on ClinicalTrials.gov More Obstetric Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ketamine (AUC)

Timeframe: 12 hour ketamine infusion

Steady State (Css)

Timeframe: 12 hours after ketamine infusion start

Elimination Half Life (T1/2) for Ketamine

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Volume of Distribution Steady State (Vdss)

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Ketamine Milk to Plasma Ratio (M:P)

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Nor-ketamine Milk to Plasma Ratio

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population

Hydroxynorketamine M:P Ratio

Timeframe: 27 hours postpartum or 24 hour CTRC appointment for weaning population