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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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).

Contacts and Locations

Contacts

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

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

• Principal Investigator: HERRERA ROSA, PhD; General University Hospital of Valencia

More Information

• 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
• Last Update Posted: September 6, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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