Effect of Epidural Dexamethasone on Labor Analgesia

Labor Clinical Trial

Official title:

Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02665936
• Other study ID #: wahdan
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 13, 2016
• Last updated: January 27, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• ASA physical status I, II

• normal vaginal delivery In early active phase of labor

• singleton cephalic presentation at term

Exclusion Criteria:

• complicated pregnancies

• morbid obesity

• diagnosed fetal abnormalities

• contra-indications to regional anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor

Intervention

Drug:
• Levobupivacaine
Levobupivacaine will be given epidurally and the duration of analgesia will be calculated
• Dexamethasone and levobupivacaine
dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured
• Levobupivacaine and Dexamethasone
dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of epidural analgesia		an average of 5 months	No
Secondary	Time of onset of sensory block at level T10	From the onset of active stage till the end of labor	an average of 5 months	No