Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section

Ankara City Hospital Bilkent45 enrolled

Overview

45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.

45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. Using CSE technique, 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anesthesia

Interventions

LevobupivacaineDRUG

this used in intratechal area and for spinal anesthesia in ceserean section

FentanylDRUG

this used in intratechal area and for spinal anesthesia in ceserean section

SufentanilDRUG

this used in intratechal area and for spinal anesthesia in ceserean section

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * pregnant women with a single live fetus aged 18-45 years old and classified as ASA I, undergoing elective cesarean section, were included the study in november 2006 to march 2007 Exclusion Criteria: * Multiple pregnancies, * preterm labor, * eclampsia, * preeclampsia, * concomitant diabetes mellitus, * allergy to local anesthetics, fentanyl or sufentanil, * contraindication for regional anesthesia were the exclusion criteria.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.

Time frame: Up to 4 months

Secondary Outcomes

Number of Participants With Pain Scores on the Visual Analog Scale

Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement were recorded.

Time frame: Up to 4 months

Data from ClinicalTrials.gov

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