Effects of Analgesics in Cesarean Section Elective

Fundación Pública Andaluza Progreso y Salud66 enrolled

Overview

Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean section. It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to decrease postoperative pain, but we try to check if one brings more benefit than the other.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anesthesia; Functional

Interventions

Hyperbaric bupivacaine+SufentanilDRUG

To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg)

Hyperbaric bupivacaine+MorphineDRUG

To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg)

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of at least 18 years. * Patients at least 36 weeks gestation. * Patients scheduled for non-urgent cesarean section. * Patients classified in the physical state of the American Society of Anesthesiologists (ASA) as grade I-II, and without important fetal pathological conditions. * Signature of informed consent that allows them to be part of the study. Exclusion Criteria: * Pregnant women who reject the spinal technique. * Patients with contraindication to spinal anesthesia. * Patients with ASA\> II classification. * Patients with multiple pregnancy. * Patients with three or more previous cesareans, * Patients with BMI greater than or equal to 40 kg / m2. * Language barrier. * Patients with pre-eclampsia. * Patients with a history of chronic pain. * Patients with a history of psychiatric or drug abuse. * Patients with allergy to any of the drugs used in the study.

Locations (1)

Hospital La Línea

Cadiz, Spain

Outcomes

Primary Outcomes

To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section.

To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine plus opioid: sufentanil or morphine, produces a longer time for the patient to administer a first analgesic bolus of intravenous morphine.

Time frame: 3 days

Secondary Outcomes

Lower intravenous morphine consumption

Time frame: 24 hours after surgery

Levels of minor pain verbal scales

The measure is based in EVA (Escala visual analógica del dolor) scale. EVA scale allows to measure the pain intensity that the patient describes with the maximum reproducibility among the observers. 1. Mild pain if the patient scores the pain as less than 3. 2. Moderate pain if the assessment is between 4 and 7. 3. Severe pain if the assessment is equal to or greater than 8.

Time frame: At 3, 6, 12 and 24 hours after surgery

Beginning of sitting and standing

Time frame: At 48 hours after surgery

Mother´s side effects with respect to hemodynamic alteration, nausea, vomits, pruritus, tremor, urinary retention, sedation, respiratory depression, headaches, motor deficits, permanent sensory or autonomic deficits.

Time frame: At intraoperative

Data from ClinicalTrials.gov

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