Effects of Analgesics in Cesarean Section Elective

NCT03386630 | Completed Phase 4

• 1 other identifier: FPS-CES-2017-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Functional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lower intravenous morphine consumption

  24 hours after surgery

• Levels of minor pain verbal scales

  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

Other Outcomes (1)

• Values in the Apgar test

  At 1 and 5 minutes after birth

Study Arms (2)

Hyperbaric bupivacaine+Sufentanil

EXPERIMENTAL

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

Hyperbaric bupivacaine+morphine

EXPERIMENTAL

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

Interventions

Hyperbaric bupivacaine+Sufentanil DRUG

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)

Also known as: Sufentanil

Hyperbaric bupivacaine+Sufentanil

Hyperbaric bupivacaine+Morphine DRUG

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)

Also known as: Morphine

Hyperbaric bupivacaine+morphine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study population will be pregnant women who will undergo elective cesarean section through Subarachnoid anesthesia.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead

Study Sites (1)

Hospital La Línea

Cadiz, 11300, Spain

Location

MeSH Terms

Interventions

Sufentanil; Morphine

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 29, 2017
• Study Start: March 28, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 28, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

ES (1)