Intrathecal Dexamethasone and Labor Analgesia

Phase 2

Completed

• Conditions: Effects of; Anesthesia, in Labor and Delivery
• Interventions: Drug: Dexamethasone; Drug: Levobupivacaine

• Registration Number: NCT02588417
• Lead Sponsor: ahmed elsakka

Brief Summary

To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery.

Detailed Description

This prospective double-blind trial included 80 primigravidas during vaginal delivery with a cervical dilatation ≥ 4 cm and 50% effacement randomly assigned to one of two equal groups; Group L received intrathecal levobupivacaine 0.25% in 2 mL and Group LD received intrathecal levobupivacaine 0.25% combined with dexamethasone 4 mg in 2 mL. At first request of analgesia, a combination of 0.25% levobupivacaine with 100 μg fentanyl in 10 ml via the epidural catheter. Further analgesia was provided with 7 ml 0.25% levobupivacaine hourly. The primary outcome measure was the duration of spinal analgesia. Secondary outcome measures include time from spinal analgesia to delivery, total amount of epidurally administered levobupivicaine, adverse effects of neuraxial block and neonatal outcome.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-09
• Status Verified: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• ASA physical status I,II patients schedueled for normal vaginal deliveries
• age between 18-35 years old

Exclusion Criteria

• Patients who refused to participate
• complicated pregnancies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethasone	Dexamethasone	dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine
dexamethasone	Levobupivacaine	dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine
levobupivacaine	Levobupivacaine	levobupivacaine 2.5 mg in 2 ml administered intrathecally during active stage of labor once and alone and then epidural levobupivacaine 7ml of 2.5 mg concentrationis administered till the end of labor

Primary Outcome Measures

Name	Time	Method
duration of spinal analgesia	1 day

Secondary Outcome Measures

Name	Time	Method
time from spinal analgesia to delivery	1 day