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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03877549
• Other study ID #: 12391
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 24, 2019
• Est. completion date: June 15, 2022

Study information

• Verified date: September 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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