Study on Lidocaine, Ropivacaine, and Epinephrine for Patients Undergoing Hand Surgery with Ultrasound-Guided Nerve Block

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What is this study about?

This clinical trial is focused on patients undergoing hand surgery, specifically for forearm fractures or thumb joint surgeries. The study is investigating the use of a specific type of anesthesia called the lateral infraclavicular plexus brachialis (LIC) block. This type of anesthesia is used to numb the area for surgery. The trial will compare the effects of combining two local anesthetics: ropivacaine and lidocaine. These medications are used to block pain in the surgical area, with ropivacaine being a long-acting anesthetic and lidocaine being a short-acting one.

The purpose of the study is to understand how these anesthetics work together in terms of how quickly they start working and how long their effects last. The trial will also look at how well they block both feeling and movement in the area. Patients will receive either the combination of these anesthetics or a placebo, and the study will measure the time it takes for pain to return after the anesthesia is given, as well as how long the numbness and inability to move last.

Participants in the study will receive the anesthetic solution through an injection near the nerves that control sensation and movement in the arm. The study will monitor the effects from the time the anesthesia is administered until the feeling and movement return to normal. This research aims to improve the effectiveness of anesthesia for hand surgeries, potentially leading to better pain management and recovery for patients.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to investigate the effect of combining short and long-acting local anesthetics for hand surgery.

The patient will undergo a screening process to confirm eligibility, focusing on those undergoing hand surgery for specific conditions like antebrachial fractures or thumb base joint procedures.

2 preparation for anesthesia

Before the surgery, the patient will receive a nerve block called the lateral infraclavicular plexus brachialis (LIC) block.

This block will be administered using a combination of local anesthetics: ropivacaine hydrochloride and lidocaine with epinephrine, both in solution form for injection.

3 administration of anesthesia

The anesthetics will be injected perineurally, which means around the nerves, to achieve the desired effect.

The goal is to compare the duration and onset time of the nerve block using these anesthetics.

4 monitoring sensory and motor block

After the block is administered, the onset of sensory block will be monitored, which is the time taken to achieve complete sensory blockade.

The total duration of both sensory and motor blockades will be recorded, from the completion of the block until their effects wear off.

5 assessment of pain and motor function

The primary endpoint is the total time to breakthrough pain, which is the time from the completion of the block to the first sensation of pain in the surgical area.

Secondary endpoints include the degree of motor blockade at the onset of sensory block and 45 minutes after the block is performed.

6 completion of trial participation

The trial is expected to conclude by June 15, 2024, with recruitment starting on March 1, 2024.

Upon completion, the patient’s participation in the trial will end, and any further follow-up will be communicated as necessary.

Who Can Join the Study?

Patients must be having hand surgery for either a broken forearm bone or a procedure to replace or repair the joint at the base of the thumb.
Both men and women can participate in the study.
Participants should be adults, as the age range includes those who are 18 years and older.
The study is not open to vulnerable populations, which means it is not designed for groups that might need special protection or care.

Who Cannot Join the Study?

Patients who are not undergoing hand surgery for forearm fractures or thumb base joint replacement.
Individuals who are not within the specified age range for the study.
Participants who are not part of the clinical trial group being studied.
People who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hddujfnb Hfzeapir	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.03.2024

Trial locations

Investigated drugs:

Lidocaine is a local anesthetic used to numb a specific area of the body. In this trial, it is being used to help block nerve signals in the arm, providing pain relief during hand surgery. The study aims to understand how quickly and how long lidocaine can provide this numbing effect when used in combination with another anesthetic.

Ropivacaine is another local anesthetic that is used to provide longer-lasting pain relief. It is being tested in this trial to see how it works with lidocaine to block nerve signals in the arm. The goal is to determine the effectiveness of this combination in terms of how quickly it starts working and how long the numbing effect lasts during hand surgery.

Antebrachial Fracture – This condition involves a break in one or both of the bones in the forearm, which are the radius and ulna. It typically occurs due to trauma or a fall on an outstretched hand. The fracture can be classified based on its location, such as distal, middle, or proximal. Symptoms often include pain, swelling, and an inability to rotate the forearm. As the fracture heals, new bone forms to bridge the broken pieces. Over time, the bone remodels and regains its strength and shape.

Thumb Base Joint Arthroplasty – This is a surgical procedure performed to replace or repair the joint at the base of the thumb, often due to arthritis. The condition leads to pain and reduced function in the thumb, affecting grip and pinch strength. Over time, the cartilage in the joint wears down, causing bones to rub against each other. This results in inflammation, pain, and stiffness. The surgery aims to relieve pain and restore function by replacing the damaged joint with an artificial implant. Recovery involves regaining strength and mobility through rehabilitation exercises.

Trial ID:

2023-510028-63-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Lidocaine, Ropivacaine, and Epinephrine for Patients Undergoing Hand Surgery with Ultrasound-Guided Nerve Block

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?