Effects of Analgesics in Cesarean Section Elective

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Sufentanil or Morphine Added to Hyperbaric Bupivacaine in Spinal Anaesthesia for Elective Caesarean Section

Conditions
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Anesthesia; Functional

Intervention / Treatment
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* Drug: Hyperbaric bupivacaine+Sufentanil
* Drug: Hyperbaric bupivacaine+Morphine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical trial, without masking techniques, is proposed in pregnant women who are to undergo elective caesarean section by subarachnoid anesthesia with hyperbaric bupivacaine associated with sufentanil or morphine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric bupivacaine+Sufentanil<br>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) | Drug: Hyperbaric bupivacaine+Sufentanil<br>* 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)<br>* Other names: Sufentanil;|
| Experimental: Hyperbaric bupivacaine+morphine<br>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) | Drug: Hyperbaric bupivacaine+Morphine<br>* 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)<br>* Other names: Morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower intravenous morphine consumption |  | 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. Mild pain if the patient scores the pain as less than 3. Moderate pain if the assessment is between 4 and 7. Severe pain if the assessment is equal to or greater than 8. | At 3, 6, 12 and 24 hours after surgery | 
| Beginning of sitting and standing |  | 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. |  | At intraoperative |