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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Parturients in their 3rd trimester who are receiving a planned cesarean delivery

• Primiparous and multiparous pregnancies

• American Society of Anesthesia (ASA) classes 1, 2 , and 3

Exclusion Criteria:

• Patients for whom neuraxial anesthesia was either declined, unsuccessful, or contraindicated

• Gestational Diabetics

• Diabetics

• Patients allergic to dexamethasone, local anesthetics, or opioids

• Patients that are immunosuppressed

• Patient who received systemic steroids within the preceding 48 hours