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Spinal Anesthesia in Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743870
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Marinella Astuto
Information provided by (Responsible Party):
Carmelo Minardi, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

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.


Condition or disease Intervention/treatment
Hypotension Drug-Induced Cesarean Section Complications Spinal Anesthetics Causing Adverse Effects in Therapeutic Use Bradycardia Drug: Levobupivacaine Drug: Bupivacaine

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spinal Anesthesia in Caesarean Section: Comparison Between Levobupivacaine and Hyperbaric Bupivacaine
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort Intervention/treatment
levobupivacaine cohort
125 pregnant patients that will have to undergo spinal anesthesia with Levobupivacaine for elective caesarean section.
Drug: Levobupivacaine
Levobupivacaine will be spinally administered, as required by normal clinical practice, at the dose of 12 mg 0,5% in combination with fentanyl 25γ.

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




Primary Outcome Measures :
  1. Changes in blood pressure measured continuously by the EV1000® platform and the Clearsight® non-invasive system (Edwards Lifesciences) in the two study cohorts [ Time Frame: From arrival in the operating room until the completion of surgical procedures ]

Secondary Outcome Measures :
  1. Incidence of hypotension during spinal anesthesia [ Time Frame: At 60 minutes after completion of surgical procedures ]
  2. Incidence of bradycardia during spinal anesthesia [ Time Frame: At 60 minutes after completion of surgical procedures ]
  3. Need for inotropes and / or vasopressor during surgery [ Time Frame: At 60 minutes after completion of surgical procedures ]
    Doses of inotropes and / or vasopressor administered during surgery

  4. Need for fluids administration during surgery [ Time Frame: At 60 minutes after completion of surgical procedures ]
    Volume of fluids administered during surgery for the eventual treatment of hypotension

  5. Level of the sensory block reached [ Time Frame: At 15 minutes from the beginning of anesthesia ]
  6. Time in which sensory block occurs [ Time Frame: At 15 minutes from the beginning of anesthesia ]
  7. Level of the sensory block reached [ Time Frame: At 30 minutes from the beginning of anesthesia ]
  8. Time in which sensory block occurs [ Time Frame: At 30 minutes from the beginning of anesthesia ]
  9. Level of sensory block reached [ Time Frame: At 60 minutes from the beginning of anesthesia ]
  10. Time in which sensory block occurs [ Time Frame: At 60 minutes from the beginning of anesthesia ]
  11. Level of the motor block reached by modified Bromage scale [ Time Frame: At 15 minutes from the beginning of anesthesia ]
    The modified Bromage scale is a six-point scale used to asses the intensity of motor block by evaluation of the patient's ability to move their lower extremities: Score 1 = Complete block (unable to move feet or knees); Score 2 = Almost complete block (able to move feet only); Score 3 = Partial block (just able to move knees); Score 4 = Detectable weakness of hip flexion while supine (full flexion of knees); Score 5 = No detectable weakness of hip flexion while supine; Score 6 = Able to perform partial knee bend. The motor block is measured in both legs intermittently throughout labour, as the degree of block can change.

  12. Level of the motor block reached by modified Bromage scale [ Time Frame: At 30 minutes from the beginning of anesthesia ]
    The modified Bromage scale is a six-point scale used to asses the intensity of motor block by evaluation of the patient's ability to move their lower extremities: Score 1 = Complete block (unable to move feet or knees); Score 2 = Almost complete block (able to move feet only); Score 3 = Partial block (just able to move knees); Score 4 = Detectable weakness of hip flexion while supine (full flexion of knees); Score 5 = No detectable weakness of hip flexion while supine; Score 6 = Able to perform partial knee bend. The motor block is measured in both legs intermittently throughout labour, as the degree of block can change.

  13. Level of the motor block reached by modified Bromage scale [ Time Frame: At 60 minutes from the beginning of anesthesia ]
    The modified Bromage scale is a six-point scale used to asses the intensity of motor block by evaluation of the patient's ability to move their lower extremities: Score 1 = Complete block (unable to move feet or knees); Score 2 = Almost complete block (able to move feet only); Score 3 = Partial block (just able to move knees); Score 4 = Detectable weakness of hip flexion while supine (full flexion of knees); Score 5 = No detectable weakness of hip flexion while supine; Score 6 = Able to perform partial knee bend. The motor block is measured in both legs intermittently throughout labour, as the degree of block can change.

  14. Aldrete score evaluation. [ Time Frame: At 15 minutes from the beginning of anesthesia ]
    The evaluation of Aldrete score, also known Post Anesthesia Recovery (PAR), focuses on the following directions: muscle activity, assessed by observing the patient's ability to move his extremities on command; respiratory efficiency, reflected by the respiratory effort; circulation, evaluated through systemic blood pressure and compared to the preanesthetic level; consciousness, reflected by full alertness and ability to answer questions; tegument color, that evaluates whether the skin aspect is normal or cyanotic or jaundiced. Each of the five items in the Aldrete score calculation is awarded from 0 to 2 points, depending on the answer chosen in the evaluation. The higher the score, the more likelihood of recovery without need of observation. Results vary between 0 and 10. Patients with scores of 9 and 10 can be safely discharged from operatory room. Scores of 10 indicate a patient in the best condition. Scores of 7 and below come with indication of continuous close observation.

  15. Aldrete's score evaluation [ Time Frame: At 30 minutes from the beginning of anesthesia ]
    The evaluation of Aldrete score, also known Post Anesthesia Recovery (PAR), focuses on the following directions: muscle activity, assessed by observing the patient's ability to move his extremities on command; respiratory efficiency, reflected by the respiratory effort; circulation, evaluated through systemic blood pressure and compared to the preanesthetic level; consciousness, reflected by full alertness and ability to answer questions; tegument color, that evaluates whether the skin aspect is normal or cyanotic or jaundiced. Each of the five items in the Aldrete score calculation is awarded from 0 to 2 points, depending on the answer chosen in the evaluation. The higher the score, the more likelihood of recovery without need of observation. Results vary between 0 and 10. Patients with scores of 9 and 10 can be safely discharged from operatory room. Scores of 10 indicate a patient in the best condition. Scores of 7 and below come with indication of continuous close observation.

  16. Aldrete's score evaluation [ Time Frame: At 60 minutes from the beginning of anesthesia ]
    The evaluation of Aldrete score, also known Post Anesthesia Recovery (PAR), focuses on the following directions: muscle activity, assessed by observing the patient's ability to move his extremities on command; respiratory efficiency, reflected by the respiratory effort; circulation, evaluated through systemic blood pressure and compared to the preanesthetic level; consciousness, reflected by full alertness and ability to answer questions; tegument color, that evaluates whether the skin aspect is normal or cyanotic or jaundiced. Each of the five items in the Aldrete score calculation is awarded from 0 to 2 points, depending on the answer chosen in the evaluation. The higher the score, the more likelihood of recovery without need of observation. Results vary between 0 and 10. Patients with scores of 9 and 10 can be safely discharged from operatory room. Scores of 10 indicate a patient in the best condition. Scores of 7 and below come with indication of continuous close observation.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03743870


Contacts
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Contact: Carmelo Minardi, MD +39 3398643162 minardi.carmelo@virgilio.it

Locations
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Italy
"G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele" Recruiting
Catania, Italy, 95123
Contact: Carmelo Minardi, MD    +39 3398643162    minardi.carmelo@virgilio.it   
Principal Investigator: Carmelo Minardi, MD         
Sub-Investigator: Marinella Astuto, MD         
Sub-Investigator: Alberto Morgana, MD         
Sponsors and Collaborators
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Marinella Astuto
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Responsible Party: Carmelo Minardi, Principal Investigator, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
ClinicalTrials.gov Identifier: NCT03743870    
Other Study ID Numbers: 125/2018/PO
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmelo Minardi, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele:
intraoperative hypotension
bupivacaine
levobupivacaine
cesarean section
spinal anaesthesia
intraoperative bradycardia
Additional relevant MeSH terms:
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Hypotension
Bradycardia
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents