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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>10cc 0.0625% bupivacaine | Drug: Dexamethasone<br>* Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section<br>|
| Experimental: Low Dose<br>4mg Dexamethasone + 10cc 0.0625% bupivacaine | Drug: Dexamethasone<br>* Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section<br>|
| Experimental: Higher Dose<br>8mg Dexamethasone + 10cc 0.0625% bupivacaine | Drug: Dexamethasone<br>* Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Visual Analog Scale for Pain, uses the Wong-Baker method of presenting faces with different reactions to pain and scales the patient based on the patient selection of a face. The range goes from 0-10. 0 is pain-free and 10 is excruciating pain. | up to 48 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea/ Vomiting Scale | Baxter Retching Faces. (BARF) pictorial faces of someone wrenching that is used to scale a patient nausea and vomiting. The range goes from 0-10. 0 is nausea-free and 10 is intractable nausea and vomiting. | up to 48 hours post-op | 
| Pruritus Score | Pruritus Scale is also a visual analog scale that has a patient rate their discomfort on a number line that gradates the severity. | up to 48 hours post-op | 
| Sedation Score | Richmond Agitation and Sedation Scale (RASS). Its a well known and utilized scale that gradates a patients level of sedation based on various responses to stimuli. The Score goes from -4 to +5. -4 represents a combative and violent patient and +5 represents a patient unresponsive to physical stimuli. | up to 48 hours post-op | 
| Motor Function | Bromage scale is a scoring system that assesses lower extremity motor function based on ones ability to flex and extend various parts of the leg. Score is 1-4. 1 is no motor block and 4 is complete motor block. | up to 48 hours post-op | 
| Satisfaction Score | Customer Satisfaction score (CSAT) is a scoring system that scores satisfaction on a 1-5 basis. 1 is very unsatisfied and 5 is very satisfied. | up to 48 hours post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, labor epidural, cesarean section