Spinal Anesthesia in Caesarean Section

NCT03743870 | Unknown

• 1 other identifier: 125/2018/PO
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is a safe technique, widely used and tested in the gynecological field, so as to be considered the first choice technique in cesarean section, which allows to quickly obtain a valid sensor and motor block. Bupivacaine is one of the most widely used drug for obtaining spinal anesthesia in pregnant women undergoing caesarean section. Bupivacaine is a local anesthetic available as a racemic mixture of its two enantiomers, the R (+)- dextrobupivacaine and the S (-) - levobupivacaine, whose clinical use is widely validated. Racemic bupivacaine is available as a simple or hyperbaric solution, the latter being the most commonly used for spinal anesthesia. Levobupivacaine, which is the pure levorotatory enantiomer of racemic bupivacaine, is a slightly hypobaric solution compared to liquor and has shown less heart and nerve toxicity, probably due to its ability to bind proteins more rapidly, and a greater selectivity towards the sensory component compared to Bupivacaine, presents action and effects better predictable. Its baricity would also offer the advantage of providing a less sensitive block to the position. Hypotension is one of the most common complications of spinal anesthesia and is particularly relevant in caesarean section because, in addition to the adverse effects on the parturient, it can have repercussions on the fetus through a reduction of placental perfusion. Some studies have showed a similar incidence of hypotension in patients treated with bupivacaine compared to those treated with levobupivacaine, while others assert an equivalence between the two drugs. In most studies, however, a significantly lower incidence of hypotension and a greater hemodynamic stability were reported in pregnant patients undergoing spinal anesthesia by caesarean section with levobupivacaine. Being both hyperbaric bupivacaine and levobupivacaine routinely used at the "G. Rodolico" Universitary Hospital of Catania for the spinal anesthesia of pregnant women undergoing caesarean section and being their use decided exclusively at discretion of the treating anesthesiologist, in the light of the discrepant data in the literature about the incidence of hypotension with the two drugs, the main objective of this observational study is to evaluate the hemodynamic effects mediated by levobupivacaine on pregnant women subjected to elective cesarean section and to compare them with those mediated by hyperbaric bupivacaine in an historical court of pregnant women subjected to caesarean section in the period between April 2017 and April 2018. The hemodynamic parameters will be monitored in real time with a non-invasive hemodynamic monitoring system (EV1000® platform + Clearsight® system - Edwards LifeSciences), routinely used in the "G. Rodolico" Universitary Hospital of Catania, allowing to obtain greater accuracy and veracity of the results compared to previous studies conducted on such anesthetics.

Conditions

Hypotension Drug-Induced; Cesarean Section Complications; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use; Bradycardia

Keywords

intraoperative hypotension; bupivacaine; levobupivacaine; cesarean section; spinal anaesthesia; intraoperative bradycardia

Outcome Measures

Primary Outcomes (1)

• Changes in blood pressure measured continuously by the EV1000® platform and the Clearsight® non-invasive system (Edwards Lifesciences) in the two study cohorts

  From arrival in the operating room until the completion of surgical procedures

Secondary Outcomes (16)

• Incidence of hypotension during spinal anesthesia

  At 60 minutes after completion of surgical procedures

• Incidence of bradycardia during spinal anesthesia

  At 60 minutes after completion of surgical procedures

• Need for inotropes and / or vasopressor during surgery

  At 60 minutes after completion of surgical procedures

• Need for fluids administration during surgery

  At 60 minutes after completion of surgical procedures

• Level of the sensory block reached

  At 15 minutes from the beginning of anesthesia

Study Arms (2)

levobupivacaine cohort

125 pregnant patients that will have to undergo spinal anesthesia with Levobupivacaine for elective caesarean section.

Drug: Levobupivacaine

bupivacaine cohort

Historical control group made of 125 patients underwent spinal anesthesia with Bupivacaine for elective cesarean section during the period between April 2017 and April 2018.

Drug: Bupivacaine

Interventions

Levobupivacaine DRUG

Levobupivacaine will be spinally administered, as required by normal clinical practice, at the dose of 12 mg 0,5% in combination with fentanyl 25γ.

levobupivacaine cohort

Bupivacaine DRUG

Bupivacaine has been spinally administered, as required by normal clinical practice, at the dose of 12 mg 0,5% in combination with fentanyl 25γ.

bupivacaine cohort

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will involve consecutive pregnant womento to be subjected/subjected to spinal anesthesia for cesarean section at the Obstetric Emergency Room of the "G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinco-Vittorio Emanuele" of Catania that meet the inclusion and criteria of the study.

You may qualify if:

• signature of informed consent
• age between 18 and 40 years old
• indication for spinal anesthesia
• American Society of Anesthesiology (ASA) classification I or II
• height less than 180 cm
• weight less than 100 kg
• absence of spinal deformities

You may not qualify if:

• age under 18 years old or over 40 yers old
• ASA III or IV
• contraindications to spinal anesthesia
• presence of hemodynamically relevant cardiovascular co-morbidities
• co-morbidities requiring invasive monitoring
• refusal of pregnant women to sign informed consent
• refusal of pregnant women to spinal anesthesia
• spinal deformities in pregnant women
• known hypersensitivity to the anesthetics used
• weight over 100 kg
• height over 180 cm
• preeclampsia or eclampsia
• presence of fetal or placental abnormalities such as placenta previa or placental abruption

Sponsors & Collaborators

• Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele: lead
• Marinella Astuto: collaborator

Study Sites (1)

"G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele"

Catania, 95123, Italy

RECRUITING

MeSH Terms

Conditions

Hypotension; Bradycardia

Interventions

Levobupivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Carmelo Minardi, MD

CONTACT

+39 3398643162; minardi.carmelo@virgilio.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 16, 2018
• Study Start: June 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: September 30, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

IT (1)