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Study on the Duration of Nerve Blocks with Lidocaine Hydrochloride for Postoperative Pain in Patients Tolerant to Opioids

Verified siteRegistered 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 a treatment for postoperative pain, which is the pain experienced after surgery. The treatment being tested is an injection of lidocaine hydrochloride, a medication commonly used to numb tissue in a specific area. The study aims to understand how long the numbing effect lasts in individuals who are used to taking opioid medications compared to those who are not.

The purpose of the study is to evaluate the onset time and duration of a radial nerve block, which is a type of local anesthesia that targets a specific nerve to block pain. Participants will receive either the lidocaine injection or a placebo, and the study will compare the effects between two groups: those who regularly use opioids for chronic pain and those who do not. The study will observe how quickly the numbing effect begins and how long it lasts in both groups.

Participants in the study will be monitored to see the differences in how the nerve block works for each group. The study will measure the time it takes for the numbing to start and how long it lasts, as well as the effect on muscle movement. This research will help to better understand pain management in people who are tolerant to opioids, potentially leading to improved treatment options for managing postoperative pain.

The research process

The trial runs in 6 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, eligibility is confirmed based on criteria such as being over 18 years old, having chronic pain for more than three months, and using a daily dose of 60 mg or more of morphine equivalent for over a month.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline information. This includes a review of medical history and current health status.
Participants are categorized into two groups: those who are opioid tolerant and those who are not.
Step 3
Administration of medication
The medication used in the study is lidocaine hydrochloride, administered as a solution for injection.
The injection is given for perineural use, which means it is administered near a nerve to block pain in a specific area.
Step 4
Monitoring and evaluation
Participants are monitored to evaluate the onset time and duration of the nerve block.
The primary focus is on the difference in the duration of sensory nerve block between the two groups.
Step 5
Follow-up assessments
Secondary assessments include measuring the onset time of sensory and motor blocks and the duration of motor nerve block.
These assessments help determine the effectiveness of the nerve block in both opioid tolerant and naive individuals.
Step 6
Completion of participation
Upon completion of the study, participants may receive a summary of their individual results.
The study is estimated to conclude by December 1, 2028.

Who can join the trial?

5 criteria

Must be older than 18 years.
Must be classified as ASA 1-3. ASA stands for the American Society of Anesthesiologists, which is a system used to assess the fitness of patients before surgery. ASA 1-3 means the patient is healthy or has mild to moderate systemic disease.
Must be legally competent and able to give informed consent. This means the patient understands the study and agrees to participate.
For the opioid group, must have chronic pain, which is pain that lasts for more than three months.
For the opioid group, must use 60 mg or more of morphine equivalent daily for more than a month. Morphine is a strong pain medication, and this requirement is for those who are used to taking such medications regularly.

Who cannot join the trial?

5 criteria

Individuals who are not experiencing postoperative pain cannot participate.
Individuals who are not within the specified age range cannot participate.
Individuals who are not either opioid tolerant or opioid naive cannot participate.
- Opioid tolerant means someone who regularly uses opioid medications and their body is used to it.
- Opioid naive means someone who does not regularly use opioid medications and their body is not used to it.
- Individuals who are part of a vulnerable population cannot participate.
  - Vulnerable population refers to groups of people who may need special protection or care, such as children, pregnant women, or those with certain disabilities.

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Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Radial Nerve Block is a type of anesthesia used to numb a specific area of the body, in this case, the radial nerve. This procedure involves injecting a local anesthetic near the nerve to block pain signals from reaching the brain. It is commonly used to provide pain relief during and after surgical procedures on the arm or hand. In this clinical trial, the radial nerve block is being studied to understand how long it lasts in people who regularly use opioids compared to those who do not.

Lidocaine Hydrochloride

What is already known about the treatment

Peripheral Nerve Block – This medication is administered through an injection near a specific nerve or group of nerves to block pain in a particular area of the body, commonly used for managing postoperative pain. Currently, it is a well-established method in medical practice and literature, particularly for pain management in surgical settings. The main therapeutic indication is to provide pain relief after surgery, especially in individuals who are tolerant to opioids. At the molecular level, it works by temporarily blocking the transmission of pain signals along the nerves. It is classified pharmacologically as a local anesthetic.

Investigated diseases

Postoperative pain – Postoperative pain is the discomfort or pain experienced by patients after undergoing surgical procedures. It is a common occurrence and can vary in intensity from mild to severe. The pain typically arises from tissue damage caused during surgery and the body's inflammatory response to this damage. It can be acute, occurring immediately after surgery, and may persist for days or weeks as the body heals. The pain can be localized to the area of surgery or may be more widespread, depending on the type and extent of the surgical procedure. Managing postoperative pain is crucial for patient comfort and recovery.