Ketamine to Improve Recovery After Cesarean Delivery - Part 1

• Status: Completed
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: Female

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. Physiochemical, PK/PD, and breastmilk transfer of ketamine and its metabolites, as well as calculated estimations for neonatal and infant exposure will be assessed in Part

1. 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 Part 2.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Grace Lim, MD, MS
• Collaborator: University of Pittsburgh
• Treatments: Ketamine

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