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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02588417
Enrollment
80
Registered
2015-10-27
Start date
2015-07-31
Completion date
2015-10-31
Last updated
2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of; Anesthesia, in Labor and Delivery

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.

Interventions

DRUGDexamethasone

4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg

DRUGLevobupivacaine

levobupivacaine 2.5 mg

Sponsors

ahmed elsakka
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
duration of spinal analgesia1 day

Secondary

MeasureTime frame
time from spinal analgesia to delivery1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026