Intrathecal Dexamethasone and Labor Analgesia

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

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

  • Drug: Dexamethasone
    • 4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg
  • Drug: Levobupivacaine
    • levobupivacaine 2.5 mg

Arms, Groups and Cohorts

  • Active Comparator: dexamethasone
    • dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • duration of spinal analgesia
    • Time Frame: 1 day

Secondary Measures

  • time from spinal analgesia to delivery
    • Time Frame: 1 day

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ahmed elsakka
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: ahmed elsakka, dr – Kasr El Aini Hospital
  • Overall Official(s)
    • nadia yo helmy, md, Principal Investigator, professor of anaesthesia cairo university

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