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Effects of Analgesics in Cesarean Section Elective (CES)

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ClinicalTrials.gov Identifier: NCT03386630
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( 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.


Condition or disease Intervention/treatment Phase
Anesthesia; Functional Drug: Hyperbaric bupivacaine+Sufentanil Drug: Hyperbaric bupivacaine+Morphine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effects of Sufentanil or Morphine Added to Hyperbaric Bupivacaine in Spinal Anaesthesia for Elective Caesarean Section
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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 Name: 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 Name: Morphine




Primary Outcome Measures :
  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. [ Time Frame: 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 :
  1. Lower intravenous morphine consumption [ Time Frame: 24 hours after surgery ]
  2. Levels of minor pain verbal scales [ Time Frame: 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.

  3. Beginning of sitting and standing [ Time Frame: At 48 hours after surgery ]
  4. 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. [ Time Frame: At intraoperative ]

Other Outcome Measures:
  1. Values in the Apgar test [ Time Frame: At 1 and 5 minutes after birth ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study population will be pregnant women who will undergo elective cesarean section through Subarachnoid anesthesia.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386630


Contacts
Contact: Francisco Javier Arroyo arroyo fernandez, MD 902 50 50 61 fcoarronimo@hotmail.com
Contact: María del Mar Benjumea Vargas 955 040 460 gestionensayosclinicos.fps@juntadeandalucia.es

Locations
Spain
Hospital La Línea Recruiting
Cadiz, Spain, 11300
Contact: Francisco Javier Arroyo Fernández, MD    956 02 65 00      
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT03386630     History of Changes
Other Study ID Numbers: FPS-CES-2017-01
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: November 2017

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

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Sufentanil
Morphine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General