Ketamine to Improve Recovery After Cesarean Delivery - Part 1

Completed · Phase 2

Conditions studied: Obstetric Pain, Postpartum Depression, Breastfeeding, Pain, Acute, Pain, Chronic, Obstetric Anesthesia Problems, Drug Effect, Opioid Use

In brief

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.

Key facts

Study ID

NCT04037085

Run by

Grace Lim, MD, MS

People needed

8

Starts

2019-10-09

Expected to finish

2021-08-01

Last updated by the study team

2022-12-20

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• UPMC Montefiore Hospital CTRC — Pittsburgh, Pennsylvania, United States
• Minhnoi C Wroble Biglan — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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