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Study on the Safety of Levobupivacaine and Bupivacaine with Fentanyl for Anesthesia in Patients Over 65 Undergoing Hip Fracture Surgery

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of anesthesia in patients aged 65 and older who are undergoing surgery for a hip fracture. The study compares two types of anesthesia: isobaric levobupivacaine and isobaric bupivacaine, both used in combination with fentanyl. These medications are administered to help manage pain during surgery. Levobupivacaine is provided as a solution for injection or infusion, while bupivacaine is combined with epinephrine in a solution for injection.

The purpose of the study is to compare the effects of these anesthetics on the heart and blood circulation. This includes monitoring blood pressure, heart rate, and oxygen levels in the blood during and after the surgery. The study aims to ensure that the anesthesia used is safe and effective for older patients undergoing hip fracture surgery. Participants will receive either levobupivacaine or bupivacaine, and some may receive a placebo. The study will observe the patients' responses to these treatments during the surgery and for up to 48 hours afterward.

Throughout the study, researchers will closely monitor various health indicators, such as blood pressure and heart rate, to assess the safety of the anesthesia. They will also track any side effects that may occur during the surgery and in the recovery period. The study is expected to continue until the end of 2025, providing valuable information on the best anesthesia practices for older adults with hip fractures.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and physical status according to the American Society of Anesthesiologists (ASA) classification.

    Eligibility criteria include being 65 years or older, having undergone hip fracture surgery, and being suitable for intradural anesthesia with either levobupivacaine and fentanyl or bupivacaine and fentanyl.

  2. Step 2

    Pre-anesthetic visit

    A pre-anesthetic visit is conducted to determine the appropriate anesthetic plan. This involves a detailed review of the patient's health status and the selection of the anesthetic combination to be used during surgery.

  3. Step 3

    Anesthesia administration

    During the surgical procedure, anesthesia is administered. The study compares the effects of isobaric levobupivacaine and isobaric bupivacaine, both combined with fentanyl.

    The medications are administered as a solution for injection or infusion.

  4. Step 4

    Monitoring during surgery

    Throughout the surgery, various parameters are monitored, including invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2), and heart rate (HR).

    These measurements help assess the hemodynamic effects of the anesthetic agents.

  5. Step 5

    Post-surgery monitoring

    After the surgery, monitoring continues for up to 48 hours to observe any adverse events related to the cardiovascular and respiratory systems.

    Additional parameters such as cardiac index (CI), peripheral vascular resistance (PVR), partial arterial oxygen pressure (PaO2), and partial arterial carbon dioxide pressure (PaCO2) are also measured.

  6. Step 6

    Follow-up

    The study includes follow-up assessments to evaluate the patient's recovery and any long-term effects of the anesthesia.

    The trial is expected to conclude by December 31, 2025.

Who can join the trial?

7 criteria

  • Patients must be 65 years or older.
  • Patients must have had hip fracture surgery.
  • Patients must be eligible for intradural anesthesia with either levobupivacaine and fentanyl or bupivacaine and fentanyl. This is determined during a pre-anesthetic visit. Intradural anesthesia is a type of anesthesia given in the spine to block pain.
  • Patients must have a physical status classified between I and IV according to the American Society of Anesthesiologists (ASA). This classification helps to assess the fitness of patients before surgery.
  • Patients must weigh more than 40 kg and be taller than 140 cm. Their Body Mass Index (BMI) should be less than 50 kg/m². BMI is a measure that uses height and weight to estimate body fat.
  • Patients must have a condition related to the heart, lungs, kidneys, or hormone/metabolism systems.
  • Patients must have provided informed consent to participate in the study. This means they understand the study and agree to take part.

Who cannot join the trial?

3 criteria

  • Patients who are younger than 65 years old cannot participate.
  • Patients who are not undergoing surgery for a hip fracture cannot participate.
  • Patients who are part of a vulnerable population, which means groups that may need special protection, cannot participate.
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Investigated drugs

  • Levobupivacaine

    is a medication used to numb a specific area of the body to prevent pain during surgery. In this trial, it is used for spinal anesthesia in patients undergoing hip fracture surgery. It helps block nerve signals in the lower part of the body, providing pain relief during the procedure.

  • Bupivacaine

    is another anesthetic used to numb a specific area of the body. Like levobupivacaine, it is used for spinal anesthesia in this trial. It works by blocking nerve signals, which helps prevent pain during hip fracture surgery.

  • Fentanyl

    is a strong pain reliever that is often used in combination with other anesthetics to enhance pain control during surgery. In this trial, it is combined with either levobupivacaine or bupivacaine to provide additional pain relief and improve the overall effectiveness of the anesthesia.

What is already known about the treatment

  • Levobupivacaine

    Levobupivacaine is administered as an injection for subarachnoid anesthesia, commonly used in surgical procedures such as hip fracture surgery. It is currently being studied for its hemodynamic safety in elderly patients. The main therapeutic indication is to provide local anesthesia during surgery. At the molecular level, levobupivacaine works by blocking sodium channels in nerve cells, preventing the transmission of pain signals. It is classified as a local anesthetic.

  • Bupivacaine

    Bupivacaine is also administered via injection for subarachnoid anesthesia, particularly in surgeries like hip fracture repair. It is under investigation for its effects on blood pressure and heart rate in older patients. The primary use is to induce local anesthesia during surgical procedures. Bupivacaine acts by inhibiting sodium channels in nerve cells, which blocks pain signal transmission. It belongs to the pharmacological class of local anesthetics.

Investigated diseases

Hip Fracture – A hip fracture is a break in the upper part of the thigh bone (femur) near the hip joint. It commonly occurs in older adults, often due to falls or weakened bones from conditions like osteoporosis. The fracture can cause severe pain in the hip or groin area, and the affected leg may appear shorter or turned outward. Movement of the hip is usually very limited and painful. Hip fractures can lead to complications if not addressed, as they significantly impact mobility and independence. Recovery often involves a combination of surgical intervention and rehabilitation to restore function.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-520970-21-00Protocol codeCoLeBuEstimated enrolment150 patientsSponsorInstituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

sourced from the EU Clinical Trials Register and site verification

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