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

Sponsor
Henry Ford Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT03877549
Collaborator
(none)
102
1
3
35.3
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Pain Scores [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Henry Ford Hospital Detroit Michigan United States 48202

Sponsors and Collaborators

  • Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joshua Younger, PI, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT03877549
Other Study ID Numbers:
  • 12391
First Posted:
Mar 15, 2019
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
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, PI, Henry Ford Health System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2021