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

Hemodynamic Safety of Isobaric Levobupivacaine Versus Isobaric Bupivacaine for Subarachnoid Anesthesia in Patients Over 65 Years Undergoing Hip Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures; Hemodynamic Stability
• Intervention / Treatment: Drug: Levobupivacaine Hydrochloride 0.5%; Drug: Isobaric bupivacaine 0.5%

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: HERRERA Rosa, PhD; Phone Number: +34 659205338; Email: 35606rhc@gmail.com
• Study Contact Backup: Name: BELDA Fco Javier, Professor; Phone Number: 973847 +34 961.973.500; Email: Fco.Javier.Belda@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario
    • Contact: HERRERA ROSA, PhD; Phone Number: +34961.973.500; Email: 35606rhc@gmail.com
    • Contact: TORNERO CARLOS, PhD; Phone Number: +34961.973.500; Email: carlos.tornero@uv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 118 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: B solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure.	The measurement of invasive systolic pressure and invasive diastolic pressure and mean blood pressure mesured in mmHg.	Intraoperative
Compare hemodynamic effects from heart rate.	The measurement of heart rate in beats per minute.	Intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Clínico Universitario de Valencia
• Investigators: Principal Investigator: HERRERA ROSA, PhD, General University Hospital of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Hip fracture, Subarachnoid block
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Bupivacaine; Levobupivacaine
• Other Study ID Numbers: CoLeBu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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