The Effects of Sufentanil or Morphine Added to Hyperbaric Bupivacaine in Spinal Anaesthesia for Elective Caesarean Section
Overview
- Phase
- Phase 4
- Intervention
- Hyperbaric bupivacaine+Sufentanil
- Conditions
- Anesthesia; Functional
- Sponsor
- Fundación Pública Andaluza Progreso y Salud
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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 / m
- •Language barrier.
- •Patients with pre-eclampsia.
- •Patients with a history of chronic pain.
- •Patients with a history of psychiatric or drug abuse.
Arms & Interventions
Hyperbaric bupivacaine+Sufentanil
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)
Intervention: Hyperbaric bupivacaine+Sufentanil
Hyperbaric bupivacaine+morphine
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)
Intervention: Hyperbaric bupivacaine+Morphine
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.
Time Frame: 3 days
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.
Secondary Outcomes
- Lower intravenous morphine consumption(24 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.(At intraoperative)
- Beginning of sitting and standing(At 48 hours after surgery)
- Levels of minor pain verbal scales(At 3, 6, 12 and 24 hours after surgery)