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

NCT03877549 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 12391
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

dexamethasone; labor epidural; cesarean section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Nausea/ Vomiting Scale

  up to 48 hours post-op

• Pruritus Score

  up to 48 hours post-op

• Sedation Score

  up to 48 hours post-op

• Motor Function

  up to 48 hours post-op

• Satisfaction Score

  up to 48 hours post-op

Study Arms (3)

Placebo

PLACEBO COMPARATOR

10cc 0.0625% bupivacaine

Drug: Dexamethasone

Low Dose

EXPERIMENTAL

4mg Dexamethasone + 10cc 0.0625% bupivacaine

Drug: Dexamethasone

Higher Dose

EXPERIMENTAL

8mg Dexamethasone + 10cc 0.0625% bupivacaine

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section

Higher Dose; Low Dose; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: May 24, 2019
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

US (1)