Intrathecal Dexamethasone and Labor Analgesia

ahmed elsakka

Status and phase: Completed; Phase 2

Conditions: Effects of; Anesthesia, in Labor and Delivery

Treatments: Drug: Levobupivacaine; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02588417

no id

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Drug: Levobupivacaine

levobupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Levobupivacaine