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

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ClinicalTrials.gov Identifier: NCT03877549
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Joshua Younger, Henry Ford Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: Dexamethasone Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
10cc 0.0625% bupivacaine
 Drug: Dexamethasone
Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section
Experimental: Low Dose
4mg Dexamethasone + 10cc 0.0625% bupivacaine
 Drug: Dexamethasone
Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section
Experimental: Higher Dose
8mg Dexamethasone + 10cc 0.0625% bupivacaine
 Drug: Dexamethasone
Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section


Outcome Measures
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Primary Outcome Measures :
  1. Pain Scores [ Time Frame: up to 48 hours post-op ]
    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.


Secondary Outcome Measures :
  1. Nausea/ Vomiting Scale [ Time Frame: up to 48 hours post-op ]
    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.

  2. Pruritus Score [ Time Frame: up to 48 hours post-op ]
    Pruritus Scale is also a visual analog scale that has a patient rate their discomfort on a number line that gradates the severity.

  3. Sedation Score [ Time Frame: up to 48 hours post-op ]
    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.

  4. Motor Function [ Time Frame: up to 48 hours post-op ]
    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.

  5. Satisfaction Score [ Time Frame: up to 48 hours post-op ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877549


Contacts
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Contact: Joshua Younger, MD 313-916-3403 jyounge1@hfhs.org

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Katherine A Nowak, MS    313-916-5174    knowak2@hfhs.org   
Contact: Joshua Younger, MD    313-598-2315    jyounge1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
More Information
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Responsible Party: Joshua Younger, PI, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03877549    
Other Study ID Numbers: 12391
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Joshua Younger, Henry Ford Health System:
dexamethasone
labor epidural
cesarean section
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents