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OpenTrials
Completed

NCT Number: NCT03386630

Effects of Analgesics in Cesarean Section Elective

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.

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Key information

Conditions

Anesthesia; Functional

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital La Línea

Cadiz, 11300, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: 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)

Other names: Morphine

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.

    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 outcomes

  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.

    • 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.

  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 outcomes

  1. Values in the Apgar test

    Time frame: At 1 and 5 minutes after birth

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Registry information

Official study title

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

Acronym: CES

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2017
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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