Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Intraoperative clonidine for postoperative pain management in patients undergoing spine surgery: a prospective, randomized, blinded, placebo-controlled trial

This research study is investigating if a medicine called clonidine, given to patients during spine surgery, can help manage pain better afterwards. The main goal is to see if patients need less strong pain medication, known as opioids, in the first few hours after waking up from their operation. This could lead to a more comfortable recovery. The study also looks at how much pain people feel, how sleepy they are, if they feel sick, and how long they stay in recovery and in hospital. This helps researchers understand the full impact of clonidine. Patients undergoing surgery for common back conditions will be involved, and everyone takes part in a private, fair way to ensure reliable results.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Aarhus Universitetshospital

Enrolment target

120

Start

29 Aug 2023

Degenerative spine diseases

What is this study about?

This research study is all about finding better ways to manage pain after spine surgery. Many people having these operations experience pain afterwards and often need strong painkillers, called opioids. While very effective, opioids can sometimes cause side effects, and doctors are always looking for ways to reduce how much is needed.

This particular study is looking at a medicine called clonidine. It’s a drug that’s been around for a while and is used for various conditions, but here, researchers are exploring if giving it during spine surgery can help reduce pain and the need for opioids in the crucial first few hours after the operation. They want to see if it makes recovery smoother and more comfortable for patients.

To make sure the results are fair and accurate, some patients will receive clonidine, while others will get a 'dummy' treatment (a placebo) that looks exactly the same but contains no active medicine. Neither the patient nor the medical team will know who is getting which, which helps prevent any bias. Researchers will then carefully compare how much pain relief is needed and how patients feel in both groups.

Key takeaways

The study aims to improve pain management after spine surgery.
It's testing if the drug clonidine can reduce strong painkiller use after surgery.
Participation involves receiving either clonidine or a dummy treatment during surgery.
Researchers will monitor pain and recovery carefully after the operation.
The study is for adults (18+) having surgery for common back problems.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also participate.

The study is open to both men and women.

The main type of health issue you would need to have to be considered for this study is a degenerative spine disease. This term covers common back problems where parts of your spine degenerate or wear down over time, often leading to pain and requiring surgery. If you're scheduled for spine surgery for one of these conditions, you might be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having spine surgery for a degenerative back condition (wear and tear)?
Are you able to follow instructions from the medical team?
Are you generally well enough to undergo surgery and recover?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of it will happen during your spine surgery. Before your operation, you would go through the usual preparation. During the surgery itself, you would receive either the study drug (clonidine) or a placebo (a dummy treatment) directly into your body, which you wouldn't notice.

After your surgery, while you are in the recovery room (PACU), the research team will carefully monitor how much pain you are in and how much pain relief medication you need for the first few hours. They'll also check things like how sleepy you are, if you feel sick, and when you are ready to leave the recovery room. You will also be asked about your pain levels over the following weeks and months, and the study will track how long you stay in hospital. There might be follow-up questions about your pain relief at home for up to a month after surgery. All these assessments are part of your normal care but will be recorded for the study.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving a treatment that might lead to better pain control after your surgery, possibly reducing your need for strong painkillers. However, there’s also a chance you might receive the placebo, meaning you wouldn’t get the active study drug. As with any medication, there’s a possibility of side effects from clonidine, which your doctors will discuss with you. Rest assured, your safety is the top priority, and you are free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is clonidine?

Clonidine is a medicine that affects your nervous system. In this study, it's being tested to see if it can help control pain after spine surgery and reduce the need for other strong painkillers.

What kind of spine surgery is this for?

This study is for people having spine surgery for common conditions where parts of the back have worn down over time. Your doctor can tell you if your specific surgery qualifies.

Will I know if I'm getting the real medicine or the dummy one?

No, neither you nor your medical team will know whether you receive clonidine or the dummy treatment. This is to make sure the results of the study are as fair and accurate as possible.

Do I have to do anything extra during the surgery?

No, you won't need to do anything extra during the surgery itself. The study medicine will be given to you by the medical team as part of your operation.

Will taking part affect my normal treatment?

No, your medical care will not be affected. You can stop participating in the study at any time without it impacting the standard medical treatment you receive.