Ketamine to Improve Recovery After Cesarean Delivery - Part 1
Sponsored by Grace Lim, MD, MS
About This Study
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.
Conditions Studied
Interventions
- •Ketamine
Eligibility
View full eligibility criteria
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 substance use/abuse, chronic opioid therapy, or chronic pain (chronic pain - defined by any condition requiring consistent follow up with pain specialist or daily administration of pain medications that could augment sedative effects) * Pre-eclampsia with severe features