Intrathecal Dexamethasone and Labor Analgesia

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

Detailed Description
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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.

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

Conditions
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Effects of; Anesthesia, in Labor and Delivery

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Levobupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone<br>dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine | Drug: Dexamethasone<br>* 4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg<br>* Other names: decadron;Drug: Levobupivacaine<br>* levobupivacaine 2.5 mg<br>* Other names: chirocaine;|
| Active Comparator: levobupivacaine<br>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 | Drug: Levobupivacaine<br>* levobupivacaine 2.5 mg<br>* Other names: chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of spinal analgesia |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from spinal analgesia to delivery |  | 1 day |