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Completed

NCT Number: NCT02588417

Intrathecal Dexamethasone and Labor Analgesia

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

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Key information

Conditions

Effects of; Anesthesia, in Labor and Delivery

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg

Other names: decadron

Levobupivacaine

Drug

levobupivacaine 2.5 mg

Other names: chirocaine

Primary outcomes

  1. duration of spinal analgesia

    Time frame: 1 day

Secondary outcomes

  1. time from spinal analgesia to delivery

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

ahmed elsakka

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2015
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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