Effect of Epidural Dexamethasone on Labor Analgesia

Phase 2

• Conditions: Labor
• Interventions: Drug: Dexamethasone and levobupivacaine; Drug: Levobupivacaine and Dexamethasone; Drug: Levobupivacaine

• Registration Number: NCT02665936
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-01
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-27
• Last Update Submitted: 2016-01-27
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group LD4	Dexamethasone and levobupivacaine	Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml
group LD8	Levobupivacaine and Dexamethasone	Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml
group L	Levobupivacaine	Epidural levobupivacaine 0.125% (Chirocaine) in normal saline in a total volume of 10 ml will be administered epidurally in active stage of labor

Primary Outcome Measures

Name	Time	Method
Duration of epidural analgesia	an average of 5 months

Secondary Outcome Measures

Name	Time	Method
Time of onset of sensory block at level T10	an average of 5 months	From the onset of active stage till the end of labor