Ketamine Tolerated Dose to Prevent Postpartum Depression and Pain After Cesarean Delivery

• Sponsor: Grace Lim, MD, MS (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05907213
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose.

The subanesthetic ketamine dose will be well tolerated and noted side effects will be acceptable by postpartum women following cesarean delivery.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Depression, Postpartum	Drug: Dose Level 1; Drug: Dose Level 2; Drug: Dose Level 3; Drug: Dose Level 4	Phase 1

Detailed Description

Pain management for women having a cesarean delivery is rather limited and risks poor pain control, depressed mood, and poor recovery following the cesarean delivery. Current cesarean pain management treatments ignore the multidimensionality of pain, including the influence of mood on pain. Recent evidence suggests that ketamine may provide successful post-surgical pain management and rapid reduction of depressive symptoms. Thus, ketamine is a great candidate for post-cesarean pain management and potential reduction of postpartum depression symptomology. The current study aims to identify an appropriate dose of ketamine for post-cesarean pain management while minimizing potential dose-dependent side effects in women following childbirth.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: MTD 3+3 designMTD 3+3 design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ketamine Tolerated Dose to Prevent Postpartum Depression and Pain After Cesarean (PREPARE1)
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Jul 1, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Loading dose Ketamine Loading dose of ketamine in 3+3 MTD for 1 hour followed by maintenance 0.05mg/kg/hr ketamine 11-hour infusion.

Drug: Dose Level 1; Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours; Other Names: 0.05 mg/kg/1hr loading dose Ketamine ; Drug: Dose Level 2; Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours; Other Names: 0.08 mg/kg/1hr loading dose Ketamine ; Drug: Dose Level 3; Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours; Other Names: 0.12 mg/kg/1hr loading dose Ketamine ; Drug: Dose Level 4; Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours; Other Names: 0.18 mg/kg/1hr loading dose Ketamine

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose [Cord clamping post-delivery to 24-hours postpartum]

   Assessment of the maximum tolerated dose based on the 3+3 method (as Percent of patients reporting tolerance at the loading dose tested)

Secondary Outcome Measures

1. Tolerability of Ketamine dose [Cord clamping post-delivery to 24-hours postpartum]

   Proportion of patient cohort reporting tolerability upon receipt of MTD

2. Acceptability of Ketamine dose [Cord clamping post-delivery to 24-hours postpartum]

   Proportion of patient cohort reporting acceptability of any reported side effects upon receipt of MTD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adults 18 years and older

• Cesarean Delivery

• American Society of Anesthesiologists Physical Status of 2 or 3

• Neuraxial anesthesia with neuraxial morphine

• Term delivery ≥37 weeks gestation

• Either planning not to breastfeed, OR receiving ketamine as part of routine clinical care

Exclusion Criteria:

• General anesthesia

• Allergy to study medications

• ASA PS 4 or higher

• Contraindications to neuraxial anesthesia

• Preterm delivery (<37 weeks gestation)

• Anticipated fetal-neonatal complex care plan

• Participating in another pain intervention trial

• Hypertensive disorder of pregnancy

• Pre-eclampsia with severe features

• Hemodynamic instability

• Medical History exclusions: ketamine or PCP (phencyclidine) abuse, schizophrenia or psychosis, liver or renal insufficiency, uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled thyroid disease, or other contraindications to ketamine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Grace Lim, MD, MS

Investigators

• Principal Investigator: Grace Lim, MD, MSc, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grace Lim, MD, MS, Associate Professor, Director of Perioperative Anesthesiology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT05907213
• Other Study ID Numbers: STUDY22100018; R01MH134538
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Grace Lim, MD, MS, Associate Professor, Director of Perioperative Anesthesiology, University of Pittsburgh: Cesarean Delivery
• Additional relevant MeSH terms: Depression, Postpartum; Pain, Postoperative; Depression; Depressive Disorder; Ketamine

Study Results

No Results Posted as of Jun 18, 2023