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

Post Operative Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03877549
Study type Interventional
Source Henry Ford Health System
Contact
Status Withdrawn
Phase Phase 4
Start date May 24, 2019
Completion date June 15, 2022
View Details
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