Ketamine to Improve Recovery After Cesarean Delivery - Part 1
CompletedPhase 2NCT04037085
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Evaluation of PK/PD, Breastmilk Transfer, and Effectiveness of Ketamine After Cesarean Delivery - Part 1
- Conditions
- Obstetric Pain
- Postpartum Depression
- Breastfeeding
- Pain, Acute
- Pain, Chronic
- Obstetric Anesthesia Problems
- Drug Effect
- Opioid Use
- Interventions
- Sponsor
- Grace Lim, MD, MS
- Collaborators
- University of Pittsburgh
- Organization
- University of Pittsburgh
- Start date
- 2019-10-09
- Primary completion
- 2021-08-01
- Sex
- Female
- Age range
- from 18 Years to 99 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04037085