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Hemodynamic Safety of Levobupivacaine vs Bupivacaine in Patients Over 65 Years Undergoing Hip Surgery

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ClinicalTrials.gov Identifier: NCT03843970
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
ROSA HERRERA, MD, Hospital Clínico Universitario de Valencia

Brief Summary:
The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.

Condition or disease Intervention/treatment Phase
Hip Fractures Hemodynamic Stability Drug: Levobupivacaine Hydrochloride 0.5% Drug: Isobaric bupivacaine 0.5% Phase 4

Detailed Description:
  1. Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial oxygen saturation (SatO2) measured in%, heart rate (HR / bpm) measured in beats per minute.

    Other variables of interest will be: cardiac index (CI) mesured in litres per minute per square metre (L/min/m2), peripheral vascular resistance (PVR) medured in dynes/seconds/cm-5, partial arterial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg, pH (pH), arterial lactate (Lc) measured in mmol / L, arterial hemoglobin (Hb) measured in g/dl, partial oxygen saturation (SpO2%) measured in %.

    1.2. Secondary objectives: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques and exitus.

  2. End points 2.1. Primary end point(s): hemodynamic variables invasive systolic blood pressure (ISBP) measured in mmHg invasive diastolic blood pressure (ISBP), measured in mmHg invasive mean blood pressure (IMBP), measured in mmHg arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg arterial oxygen saturation (SatO2) measured in% heart rate (HR / bpm) measured in beats per minute cardiac index (CI) mesured in litres per minute per square metre (L/min/m2). peripheral vascular resistance (PVR) mesured in dynes/seconds/cm-5 partial arterial pressure of oxygen (PaO2) measured in mmHg arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg pH (pH) arterial lactate (Lc) measured in mmol / L arterial hemoglobin (Hb) measured in g / dl partial oxygen saturation (SpO2%) measured in %.

2.1.1 Timepoint(s) of evaluation of this end point: entry into the operating room, after 30 minutes of anesthesia and at the end of anesthesia.

2.2. Secondary end point(s):

A. Intraoperative adverse events:

  1. Cardiovascular and Respiratory: Venous air embolism (VAE), deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
  2. Other: Acute renal failure (ARF), vomiting (V)
  3. Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), nerve damage (ln), femur fracture (Fx f)
  4. Associated with the anesthetic technique: paresthesia (pair), hematic puncture (ph), other.

B.Postoperative adverse events (at 48 hours)

  1. Cardiovascular and Respiratory: Deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
  2. Other: Acute renal failure (ARF), UTI (Infu), vomiting (V).
  3. Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), neurologic deficit (defnq), surgical wound infection (Infhq).
  4. Associated with the anesthetic technique: neurological deficit (defn), postdural puncture headache (PDPH), back pain (Lumb).

2.2.1. Timepoint(s) of evaluation of this end point: 48 hours of surgery

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Safety of Isobaric Levobupivacaine Versus Isobaric Bupivacaine for Subarachnoid Anesthesia in Patients Over 65 Years Undergoing Hip Surgery
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levobupivacaine Hydrochloride 0,5%
The doses used of Levobupivacaine Hydrochloride 0.5% will be 6 mg and the dose of fentanyl 10 μg.
Drug: Levobupivacaine Hydrochloride 0.5%
The solution is called L solution, which contains a combination of 0.5% isobaric levobupivacaine with fentanyl. Injectable Solution.
Other Name: L solution

Active Comparator: isobaric bupivacaine 0,5%
The doses used of isobaric bupivacaine will be 6 mg and the dose of fentanyl 10 μg.
Drug: Isobaric bupivacaine 0.5%
The solution is called B solution, which contains a combination of 0.5% isobaric bupivacaine with fentanyl. Injectable Solution.
Other Name: B solution




Primary Outcome Measures :
  1. Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure. [ Time Frame: Intraoperative ]
    The measurement of invasive systolic pressure and invasive diastolic pressure and mean blood pressure mesured in mmHg.

  2. Compare hemodynamic effects from heart rate. [ Time Frame: Intraoperative ]
    The measurement of heart rate in beats per minute.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 48 hours of surgery ]
    Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques.



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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and Women over 65 years
  • Who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine or bupivacaine, both with fentanyl,
  • Fitness: from I to IV, according to the American Society of Anesthesiologists (ASA),
  • Weight> 40 kg,
  • Height> 140 cm,
  • Body mass index (BMI) <50 kg/m2,
  • Pathology cardiovascular, respiratory, renal and endocrine-metabolic,
  • Provide written informed consent

Exclusion Criteria:

  • Patients with uncontrolled hypertension (non-invasive systolic blood pressure> 180 mmHg and / or non-invasive diastolic blood pressure > 110mmHg),
  • HR> 120 bpm,
  • SpO2 <90% on arrival in the operating room and the contraindication to perform neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, morbid obesity, and extreme increase in intracranial pressure).

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): NCT03843970


Contacts
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Contact: HERRERA Rosa, PhD +34 659205338 35606rhc@gmail.com
Contact: BELDA Fco Javier, Professor +34 961.973.500 ext 973847 Fco.Javier.Belda@uv.es

Locations
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Spain
Hospital Clínico Universitario Recruiting
Valencia, Spain, 46010
Contact: HERRERA ROSA, PhD    +34961.973.500    35606rhc@gmail.com   
Contact: TORNERO CARLOS, PhD    +34961.973.500    carlos.tornero@uv.es   
Sponsors and Collaborators
Hospital Clínico Universitario de Valencia
Investigators
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Principal Investigator: HERRERA ROSA, PhD General University Hospital of Valencia
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Responsible Party: ROSA HERRERA, MD, Principal Investigator, Hospital Clínico Universitario de Valencia
ClinicalTrials.gov Identifier: NCT03843970    
Other Study ID Numbers: CoLeBu
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Keywords provided by ROSA HERRERA, MD, Hospital Clínico Universitario de Valencia:
Hip fracture, Subarachnoid block
Additional relevant MeSH terms:
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Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Bupivacaine
Levobupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents