Clinical Trials Directory

Trials / Completed

CompletedNCT02588417

Intrathecal Dexamethasone and Labor Analgesia

Intrathecal Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Combined Spinal Epidural for Vaginal Delivery Analgesia: A Comparative Study.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
80 (actual)
Sponsor
ahmed elsakka · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexamethasone4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg
DRUGLevobupivacainelevobupivacaine 2.5 mg

Timeline

Start date
2015-07-01
Primary completion
2015-09-01
Completion
2015-10-01
First posted
2015-10-27
Last updated
2015-10-28

Source: ClinicalTrials.gov record NCT02588417. Inclusion in this directory is not an endorsement.