Intrathecal Dexamethasone and Labor Analgesia

NCT ID: NCT02588417

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Effects of; Anesthesia, in Labor and Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

dexamethasone

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg

Levobupivacaine

Intervention Type: DRUG

levobupivacaine 2.5 mg

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

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

levobupivacaine 2.5 mg

Interventions

Dexamethasone

4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg

Intervention Type: DRUG

Levobupivacaine

levobupivacaine 2.5 mg

Intervention Type: DRUG

Other Intervention Names

decadron; chirocaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ahmed elsakka

OTHER

Sponsor Role: lead

Responsible Party

ahmed elsakka

dr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

nadia yo helmy, md

Role: PRINCIPAL_INVESTIGATOR

professor of anaesthesia cairo university

Other Identifiers

no id

Identifier Type: -

Identifier Source: org_study_id