Status:
COMPLETED
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
Lead Sponsor:
Grace Lim, MD, MS
Collaborating Sponsors:
University of Pittsburgh
Conditions:
Obstetric Pain
Postpartum Depression
Eligibility:
FEMALE
18-99 years
Phase:
PHASE2
Brief 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, a...
Detailed Description
Postpartum pain management strategies currently permit opioids for breakthrough pain, but strategies focused on minimizing or eliminating opioids are lacking. In the non-obstetric surgical population,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04037085
Start Date
October 9 2019
End Date
August 1 2021
Last Update
December 20 2022
Active Locations (2)
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1
UPMC Montefiore Hospital CTRC
Pittsburgh, Pennsylvania, United States, 15213
2
Minhnoi C Wroble Biglan
Pittsburgh, Pennsylvania, United States, 15232