Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

Tanta University90 enrolled

Overview

Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics. The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Epidural Analgesia Painless Labor Dexmedetomidine Fentanyl Levobupivacaine

Interventions

levobupivacaineDRUG

The patients will receive 15 ml of 0.125% levobupivacaine.

DexmedetomidineDRUG

The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.

FentanylDRUG

The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 41 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status class II and III, * Full term pregnancy. Exclusion Criteria: * Patient refusal to epidural analgesia, * Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis), * Cardiac diseases * Severe pre-eclampsia, * Breech presentations * Antepartum hemorrhage * Cephalopelvic disproportion * Body mass index ≥40 kg/m2.

Locations (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

Outcomes

Primary Outcomes

Duration of maternal analgesia

Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4. The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, \> 7: severe pain).

Time frame: 24 hours after epidural injection

Secondary Outcomes

Onset of maternal analgesia.

The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) \<3.

Time frame: One hour after epidural injection

Complications of drugs of epidural technique

Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)

Time frame: 24 hours after epidural injection

Data from ClinicalTrials.gov

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