Effects of Analgesics in Cesarean Section Elective (CES)

Fundación Pública Andaluza Progreso y Salud

Status and phase: Completed; Phase 4

Conditions: Anesthesia; Functional

Treatments: Drug: Hyperbaric bupivacaine+Morphine; Drug: Hyperbaric bupivacaine+Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03386630

FPS-CES-2017-01

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Hyperbaric bupivacaine+Sufentanil

Experimental group

Description:

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)

Treatment:

Drug: Hyperbaric bupivacaine+Sufentanil

Hyperbaric bupivacaine+morphine

Experimental group

Description:

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)

Treatment:

Drug: Hyperbaric bupivacaine+Morphine