Not recruiting

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

Registered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

4 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

Levobupivacaine

What is already known about the treatment

Paracetamol – Paracetamol is typically administered orally in tablet or liquid form, and it can also be given intravenously. It is widely used in medicine as a pain reliever and fever reducer. The main therapeutic indications include mild to moderate pain relief and fever reduction. At the molecular level, paracetamol works by inhibiting the production of prostaglandins in the brain, which are chemicals that promote inflammation, pain, and fever. It is classified as an analgesic and antipyretic medication.

Investigated diseases

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.

Hip fracture

Trial detailsLast updated 2 Oct 2026

Age: 18+ years
Phase: Phase III
Trial ID i: 2024-511528-15-00
Estimated enrolment: 170 patients
Sponsor: Asociacion Gallega De Anestesiologia Reanimacion Y Dolor

Want to learn more about this trial or check if you can participate?

Trial detailsLast updated 2 Oct 2026

Age18+ yearsPhasePhase IIITrial ID2024-511528-15-00Estimated enrolment170 patientsSponsorAsociacion Gallega De Anestesiologia Reanimacion Y Dolor

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

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

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

schedule The research process

Joining the study

Pre-surgery assessment

Surgery and pain management

Postoperative evaluation

Follow-up and satisfaction assessment

Who can join the trial?

Who cannot join the trial?

Prefer not to search? Our Concierge searches the trials for you.

Trial locations

signpost Not sure what to do next?

medication Investigated drugs

What is already known about the treatment

stethoscope Investigated diseases

Ongoing clinical trials in Hip fracture

Prefer not to search? Our Concierge searches the trials for you.

The research process

Not sure what to do next?

Investigated drugs

Investigated diseases