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

Primary Purpose

Post Operative Pain

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring dexamethasone, labor epidural, cesarean section

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Low Dose

Higher Dose

Arm Description

10cc 0.0625% bupivacaine

4mg Dexamethasone + 10cc 0.0625% bupivacaine

8mg Dexamethasone + 10cc 0.0625% bupivacaine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 14, 2019
Last Updated
September 22, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03877549
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI left Henry Ford Health before completion.
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
dexamethasone, labor epidural, cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10cc 0.0625% bupivacaine
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
4mg Dexamethasone + 10cc 0.0625% bupivacaine
Arm Title
Higher Dose
Arm Type
Experimental
Arm Description
8mg Dexamethasone + 10cc 0.0625% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section
Primary Outcome Measure Information:
Title
Pain Scores
Description
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.
Time Frame
up to 48 hours post-op
Secondary Outcome Measure Information:
Title
Nausea/ Vomiting Scale
Description
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.
Time Frame
up to 48 hours post-op
Title
Pruritus Score
Description
Pruritus Scale is also a visual analog scale that has a patient rate their discomfort on a number line that gradates the severity.
Time Frame
up to 48 hours post-op
Title
Sedation Score
Description
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.
Time Frame
up to 48 hours post-op
Title
Motor Function
Description
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.
Time Frame
up to 48 hours post-op
Title
Satisfaction Score
Description
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.
Time Frame
up to 48 hours post-op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

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

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