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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.03.2018

Trial locations

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.

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 ID:
2025-520970-21-00
Protocol code:
CoLeBu
Trial Phase:
Therapeutic confirmatory (Phase III)

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