Effects of Analgesics in Cesarean Section Elective

Anesthesia; Functional Clinical Trial

— CES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386630
• Other study ID #: FPS-CES-2017-01
• Status: Completed
• Phase: Phase 4
• Start date: March 28, 2018
• Est. completion date: July 28, 2019

Study information

• Verified date: January 2020
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 28, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia; Functional

Intervention

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)
• 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)

Locations

Country	Name	City	State
Spain	Hospital La Línea	Cadiz

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Values in the Apgar test		At 1 and 5 minutes after birth
Primary	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	Lower intravenous morphine consumption		24 hours after surgery
Secondary	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
Secondary	Beginning of sitting and standing		At 48 hours after surgery
Secondary	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