Clinical trial NCT03877549: Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery
Official title: Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: dexamethasone
labor epidural
cesarean section
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Pain Scores
timeFrame: up to 48 hours post-op
Secondary outcomes:
measure: Nausea/ Vomiting Scale
timeFrame: up to 48 hours post-op
measure: Pruritus Score
timeFrame: up to 48 hours post-op
measure: Sedation Score
timeFrame: up to 48 hours post-op
measure: Motor Function
timeFrame: up to 48 hours post-op
measure: Satisfaction Score
timeFrame: up to 48 hours post-op
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References: