NCT03877549

Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. Patients undergoing elective cesarean sections will be randomized into three groups, each receiving the same combined spinal epidural (CSE). At surgical closure, Group 1 will receive 10cc bupivacaine 0.0625%, Group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and Group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). VAS, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare the outcomes of the different treatment groups.

Detailed description

This study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. Patients undergoing elective cesarean sections will be randomized into three groups using a random allocation table. Group assignment will be performed by opening a previously prepared numbered opaque envelope containing the assignment. Each group will receive the same combined spinal epidural (CSE) containing 10-12mg hyperbaric bupivacaine, 150mcg preservative-free morphine, and 15mcg fentanyl. At surgical closure, Group 1 will receive 10cc bupivacaine 0.0625%, Group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and Group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). In order to maintain this as a double-blinded study, the patient will not be told which medication was administered and the drug will be given by one anesthesiologist and the patient follow-up will be performed by a different anesthesiologist. VAS, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare how these outcomes compare between the different treatment groups.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	Dexamethasone	Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section

Timeline

• Start date: 2019-05-24
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2019-03-15
• Last updated: 2023-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study