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
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone | 4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg |
| DRUG | Levobupivacaine | levobupivacaine 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.