Effects of Analgesics in Cesarean Section Elective

Phase 4

Completed

• Conditions: Anesthesia; Functional
• Interventions: Drug: Hyperbaric bupivacaine+Sufentanil; Drug: Hyperbaric bupivacaine+Morphine

• Registration Number: NCT03386630
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-12-28
• Study First Posted: 2017-12-29
• Study Start: 2018-03-28
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-28
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric bupivacaine+Sufentanil	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)
Hyperbaric bupivacaine+morphine	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)

Primary Outcome Measures

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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Hospital La Línea; 🇪🇸 Cadiz, Spain