Effects of Analgesics in Cesarean Section Elective (CES)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Functional
• Intervention / Treatment: Drug: Hyperbaric bupivacaine+Sufentanil; Drug: Hyperbaric bupivacaine+Morphine

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Cadiz, Spain, 11300
    • Hospital La Línea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: 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); Other Names: Sufentanil
Experimental: 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)	Drug: 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); Other Names: Morphine

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Values in the Apgar test	At 1 and 5 minutes after birth

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza Progreso y Salud

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): July 28, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Bupivacaine; Morphine; Sufentanil; Dsuvia
• Other Study ID Numbers: FPS-CES-2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No