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Clonidine Hydrochloride for Pain Management After Spine Surgery in Patients with Degenerative Spine Diseases

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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 managing pain after spine surgery in patients with degenerative spine diseases. The study is investigating the use of a medication called Clonidine, which is given during surgery to help reduce the need for pain medication after the operation. The trial aims to see how effective and safe Clonidine is in reducing the amount of pain medication needed after surgery.

Participants in the study will receive either Clonidine or a placebo during their spine surgery. The study will monitor the amount of pain medication needed after surgery, as well as other factors like pain levels, sedation, nausea, and the time it takes for patients to be discharged from the recovery area. The study will also look at the length of the hospital stay and the amount of pain medication needed one month after surgery.

The trial is designed to provide valuable information on how Clonidine can be used to manage pain after spine surgery, potentially improving recovery and reducing the need for other pain medications. The study will run until August 2025, with recruitment having started in August 2023.

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 trial
Upon joining the trial, you will be scheduled for surgery to address degenerative spine diseases.
You will be informed about the trial's purpose, which is to study the effectiveness and safety of a medication called clonidine in managing pain after spine surgery.
Step 2
Surgery and medication administration
During your surgery, you will receive an infusion of clonidine hydrochloride as part of the trial. This is a solution given through a vein to help manage pain after the operation.
You will also receive sodium chloride solutions as part of the standard procedure.
Step 3
Post-surgery monitoring
After surgery, you will be taken to the Post-Anesthesia Care Unit (PACU) where your recovery will be closely monitored.
Your opioid consumption will be measured within the first 3 hours and then again within the first 6 hours after arriving at the PACU.
Step 4
Pain and sedation assessment
Your pain levels will be assessed at rest and during coughing at 0, 30, 60, 90, and 120 minutes after arriving at the PACU using a Numeric Rating Scale from 0 to 10.
Your level of sedation will be evaluated at 0, 60, and 120 minutes using the Ramsey Sedation Score.
Step 5
Nausea and discharge evaluation
You will be checked for any nausea or vomiting at 0, 60, and 120 minutes after arriving at the PACU.
The time it takes for you to be discharged from the PACU will be recorded.
Step 6
Follow-up and hospital stay
Your daily opioid consumption will be monitored for one month after surgery.
The length of your hospital stay will be documented as part of the trial.

Who can join the trial?

4 criteria

Patients must be scheduled for surgery to treat degenerative spine diseases.
Patients must be between the ages of 18 and 64.
Both male and female patients can participate.
Patients should not be part of a vulnerable population, which means they should be able to make decisions for themselves and not be in a situation where they are easily influenced or at risk.

Who cannot join the trial?

10 criteria

Patients with any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medication or similar drugs.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients who have had a recent surgery or are planning to have surgery soon.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of heart problems.
Patients who are unable to follow the study procedures or instructions.

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Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Clonidine is a medication used in this clinical trial to help manage pain after spine surgery. It is given to patients during the surgery through an intravenous line, which means it is delivered directly into the bloodstream. The main goal of using clonidine in this trial is to see if it can reduce the need for other pain medications, like opioids, after the surgery. Clonidine works by affecting certain parts of the brain to help decrease pain signals, which might help patients feel less pain and need fewer painkillers after their operation.

What is already known about the treatment

Clonidine – Clonidine is administered intravenously during surgery to help manage pain after the procedure, particularly in patients undergoing spine surgery. It is currently being studied in clinical trials to assess its effectiveness in reducing the need for opioids after surgery. The main therapeutic use of clonidine in this context is to provide pain relief. At the molecular level, clonidine works by stimulating certain receptors in the brain, which helps to reduce pain signals. It is classified as an alpha-2 adrenergic agonist, a type of medication that can help calm the nervous system and reduce pain.

Investigated diseases

Degenerative Spine Diseases – Degenerative spine diseases refer to a group of conditions that involve the gradual deterioration of the spine's structure and function. These diseases often affect the intervertebral discs, vertebrae, and joints, leading to symptoms such as pain, stiffness, and reduced mobility. As the spine degenerates, it may cause nerve compression, resulting in numbness, tingling, or weakness in the limbs. The progression of these diseases can vary, with some individuals experiencing slow changes over many years, while others may notice more rapid deterioration. Factors such as age, genetics, and lifestyle can influence the rate of progression. Common examples include osteoarthritis of the spine and degenerative disc disease.