5000 Participants Needed

Cryoanalgesia for Postoperative Pain

(REDUCE Trial)

Recruiting at 6 trial locations
EM
LO
Overseen ByLaura O'Brien, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: AtriCure, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of cryoanalgesia, a method of freezing nerves to reduce pain, for managing post-surgery pain. It targets the intercostal nerves, which run between the ribs. Individuals who have undergone or are scheduled for this nerve-freezing treatment for post-surgery pain relief may be suitable candidates.

As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early-stage findings.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cryoanalgesia of the intercostal nerves is safe for post-operative pain management?

Research has shown that cryoanalgesia, which uses extreme cold to numb nerve fibers, is a promising method for pain relief. Studies indicate that it provides long-lasting relief by temporarily stopping the function of nerves between the ribs. This treatment eliminates the need for repeated nerve block injections, which can have side effects.

Evidence suggests that cryoanalgesia is well-tolerated and avoids the risks associated with some long-lasting pain medications. While it temporarily interrupts nerve function, it does not cause permanent damage. This reversibility makes it a safe option for managing pain, especially after surgery. So far, studies have not frequently reported any significant adverse effects.12345

Why are researchers excited about this trial?

Cryoanalgesia of the intercostal nerves is unique because it targets pain directly by freezing the nerves responsible for transmitting pain signals. This method stands out from typical pain management approaches, such as medications or nerve blocks, which can have systemic side effects or provide only temporary relief. Researchers are excited because cryoanalgesia offers the potential for longer-lasting pain relief with minimal side effects, presenting a promising option for individuals seeking effective management of pain in the chest area.

What evidence suggests that cryoanalgesia of the intercostal nerves is effective for post-operative pain management?

Research has shown that freezing the nerves between the ribs, known as cryoanalgesia, can help manage post-surgical pain. One study found that patients experienced less pain and required fewer painkillers in the first 24 hours after surgery. Another study confirmed the safety and effectiveness of this method for pain relief following chest surgery. Some studies also noted reduced pain medication use when cryoanalgesia was part of the treatment. However, one study did not observe a decrease in pain or painkiller use and reported an increase in nerve-related pain a few weeks after treatment. Overall, while more research is needed, this treatment appears promising in certain situations.678910

Who Is on the Research Team?

CQ

Curits Quinn, MD

Principal Investigator

Elliot Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 12 years or older and can legally consent to treatment.
I am scheduled for or have had cryoablation of intercostal nerves with an AtriCure device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryoablation of the intercostal nerves for post-operative pain management

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cryoanalgesia of the Intercostal Nerves

Find a Clinic Near You

Who Is Running the Clinical Trial?

AtriCure, Inc.

Lead Sponsor

Trials
43
Recruited
22,800+

Citations

Intercostal nerve cryoanalgesia in the treatment of pain ...We noticed lower NRS points in first 24 h (p = 0.0048), shortening of time of opioid use (p = 0.0002), hospitalisation time (p = 0,01), improved ...
A randomized study of cryoablation of intercostal nerves in ...In this randomized study, cryoanalgesia did not decrease postoperative pain or narcotic requirements. Cryoanalgesia increased neuropathic pain 2 weeks after ...
156. Efficacy of Intercostal Cryoanalgesia in Patients ...Cryoanalgesia did not increase neuralgia. Cryoanalgesia appears effective and safe. Larger studies are necessary for validation, especially in patients where ...
Efficacy of Intercostal CryoAnalgesia in Robotic Lung ...Intercostal cryoanalgesia has been shown to be a safe and effective strategy for postoperative pain management in patients undergoing thoracotomy.
Efficacy of intercostal cryoneurolysis as an analgesic ...A majority of studies demonstrated decreased inpatient narcotic use with intercostal cryoneurolysis compared with conventional pain modalities.
Cryoanalgesia - StatPearls - NCBI Bookshelf - NIHCryoanalgesia is a specialized technique for providing long-term pain relief in interventional pain management settings.
Intercostal cryoanalgesia for acute pain after video ...Cryoanalgesia entails the application of cold to targeted nerve fibers, achieving temperatures between −20 and −100 °C and inducing reversible ...
Role of intercostal nerve block and cryoneurolysis in the ...Cryoneurolysis provides extended yet reversible pain control by temporarily disrupting intercostal nerve function. Comparative studies suggest ...
Cryoanalgesia and Therapeutic Cold - Medical Clinical ...Cryoanalgesia of the intercostal nerves circumvents the need for repetitive injections of nerve blocks and avoids the toxicity of long acting agents, which may ...
ultrasound-guided percutaneous cryoanalgesia of ...Cryoanalgesia is a good option for pain treatment after thoracic surgery [4]. Cold applied directly on intercostal nerve surface induces ...
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