Study on Pain Relief in Hip Fracture Surgery: Comparing Levobupivacaine Block with No Block for Patients Undergoing Hip and Proximal Femur Surgery

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What is this study about?

This clinical trial is focused on studying the treatment of hip fractures, a common injury that often requires surgery. The study will explore the use of a treatment called the Erectus Spinae Plane Lumbar (ESP-L) block, which is a type of pain relief method used during and after surgery. This method involves using a medication called Levobupivacaine, which is a solution for injection or infusion, to help manage pain by blocking nerve signals in a specific area of the back.

The purpose of the study is to compare the effectiveness and safety of the ESP-L block with not using any local pain relief method during hip surgery. Participants in the study will either receive the ESP-L block or no block at all. The study aims to see if the ESP-L block can reduce pain by at least one point on a pain scale two hours after surgery. Additionally, the study will look at how much pain medication is needed after surgery, the use of opioids, the ease of performing the block, any side effects, and how satisfied patients are with their pain management.

The study will follow participants through their surgery and recovery, observing their pain levels and overall experience. This research is important for understanding how to better manage pain for patients undergoing hip surgery, potentially leading to improved recovery and comfort.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to compare the effectiveness and safety of a specific pain management technique during hip surgery.

The patient will be required to sign a consent form, confirming their understanding of the study and their willingness to participate.

2 pre-surgery assessment

Before the surgery, the patient’s eligibility will be confirmed. This includes being over 18 years of age, undergoing hip surgery, and having a low to moderate anesthetic risk as classified by the American Society of Anesthesiologists (ASA I-III).

The patient will be educated on how to assess pain using a visual scale.

3 surgery and pain management

During the surgery, the patient will either receive a lumbar Erectus Spinae Plane (ESP) block or no locoregional block, depending on the group they are assigned to.

The ESP block involves the use of levobupivacaine, a medication administered as a solution for injection or infusion, to manage pain.

4 postoperative evaluation

After the surgery, the patient’s pain levels will be assessed using the Visual Analogue Scale (VAS). The goal is to achieve a reduction in pain by at least 1 point two hours after the operation.

The patient’s need for additional pain relief and any side effects will be monitored and compared between the two groups.

5 follow-up and satisfaction assessment

The patient’s satisfaction with the pain management technique will be evaluated.

The study will also compare the ease of performing the ESP block and the overall consumption of pain relief medications between the two groups.

Who Can Join the Study?

Patients must be undergoing hip surgery.
Patients must be over 18 years of age.
Both men and women can participate.
Patients must be classified as ASA I-III. This is a system used by the American Society of Anesthesiologists to assess the risk of anesthesia, where I is low risk and III is moderate risk.
Patients must understand how to assess pain using a visual scale, known as the Visual Analogue Scale (VAS), which is a tool to measure pain intensity.
Patients must sign a consent form to participate in the study.

Who Cannot Join the Study?

Patients who have a hip fracture cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not undergoing hip or upper thigh bone surgery cannot participate.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Alvaro Cunqueiro	Vigo	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Levobupivacaine

Erectus Spinae Plane Lumbar (ESP-L) Block is a type of regional anesthesia used to manage pain. In this clinical trial, it is being tested for its effectiveness in reducing pain for patients undergoing hip and proximal femur surgery. The ESP-L block involves injecting a local anesthetic near the spine to block pain signals from reaching the brain, potentially providing significant pain relief after surgery.

Investigated diseases:

Hip fracture

Hip Fracture – A hip fracture is a break in the upper part of the femur, near the hip joint. It often occurs in older adults due to falls or weakened bones from conditions like osteoporosis. The fracture can cause severe pain, swelling, and difficulty moving the leg. It typically requires surgical intervention to repair the break and restore mobility. Recovery involves a combination of rest, physical therapy, and gradual return to activity. Hip fractures can significantly impact a person’s ability to perform daily activities independently.

Trial ID:

2024-511528-15-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pain Relief in Hip Fracture Surgery: Comparing Levobupivacaine Block with No Block for Patients Undergoing Hip and Proximal Femur Surgery

What is this study about?

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