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

Henry Ford Health

Status and phase: Withdrawn; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03877549

12391

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

10cc 0.0625% bupivacaine

Treatment:

Drug: Dexamethasone

Low Dose

Experimental group

Description:

4mg Dexamethasone + 10cc 0.0625% bupivacaine

Treatment:

Drug: Dexamethasone

Higher Dose

Experimental group

Description:

8mg Dexamethasone + 10cc 0.0625% bupivacaine

Treatment:

Drug: Dexamethasone