Cryoanalgesia for Postoperative Pain Management

Not yet recruiting at 1 trial location
SS
JL
Overseen ByJenny Lester, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
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 tests a new method to manage pain after a double lung transplant. During surgery, doctors will use a special cold-therapy probe (intercostal cryoanalgesia) to numb nerves near the incision, aiming to reduce the need for strong pain medicines like opioids. Researchers aim to determine if this approach can improve patient recovery. Individuals undergoing a double lung transplant without a history of multi-organ or redo lung transplants might be suitable for this trial. As an unphased trial, this study offers patients an opportunity to contribute to innovative pain management research that could enhance recovery experiences.

Will I have to stop taking my current medications?

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 this method is safe for postoperative pain management?

Research has shown that intercostal cryoanalgesia, a method for managing pain by freezing nerves, is generally well-tolerated. Studies have found it effectively reduces pain after surgeries like lung transplants. Available data indicates that complications are rare, and patients report positive results.

Additionally, the AtriCure cryoSPHERE MAX Probe, used in this treatment, has already been approved for blocking pain in other surgeries, meaning it has passed safety checks for similar uses.

Overall, while no treatment is without risks, intercostal cryoanalgesia appears to be a safe option for managing pain after surgery.12345

Why are researchers excited about this trial?

Researchers are excited about intercostal cryoanalgesia for postoperative pain management because it offers a novel approach to pain relief by using extreme cold temperatures to numb nerves directly. Unlike traditional pain management options, such as opioids or standard nerve blocks, this technique targets the nerves with precision during surgery, potentially reducing the need for additional pain medications afterward. This could lead to fewer side effects and a faster recovery for patients, making it a promising advancement in postoperative care.

What evidence suggests that intercostal cryoanalgesia is effective for managing postoperative pain after a double lung transplant?

Research has shown that intercostal cryoanalgesia, which uses a cold probe to numb nerves, can greatly reduce post-surgery pain. In this trial, participants in the experimental treatment arm will receive intercostal cryoanalgesia using the Atricure CryoSPHERE MAX Probe. One study found that this method lowered the need for painkillers like oxycodone in the first five days after surgery. Another study demonstrated that it also reduced overall complications, especially breathing problems, after operations. A meta-analysis, which combines data from several studies, confirmed that cryoanalgesia reduces the need for opioids and decreases pain in lung transplant patients. These findings suggest that cryoanalgesia could effectively manage pain after a double lung transplant.16789

Who Is on the Research Team?

AA

Abbas Ardehali, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone a double lung transplant and are looking to manage post-operative pain. The study aims to reduce reliance on opioids for pain relief.

Inclusion Criteria

I am 18 years old or older.
I am having a double lung transplant through specific surgical methods.

Exclusion Criteria

Redo lung transplant recipients
I have received multiple organ transplants.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo double lung transplant surgery with or without the use of the Atricure CryoSPHERE MAX Probe for pain management

Surgery day
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for opioid use, pain scores, and ICU stay duration for the first 10 days post-surgery

10 days

Follow-up

Participants are monitored for recovery and long-term effects of the treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Intercostal Cryoanalgesia

Trial Overview

The intervention being tested is the Atricure CryoSPHERE MAX Probe, a cold-therapy device used during surgery to numb nerves near the incision site, potentially reducing opioid use and aiding recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

AtriCure, Inc.

Industry Sponsor

Trials
43
Recruited
22,800+

Citations

Intercostal nerves cryoanalgesia and open thoracotomy for ...

Cryoanalgesia significantly reduced overall postoperative complications (24.1% vs 50.0%, p=0.034), particularly respiratory complications (10.3% ...

Intercostal nerve cryoanalgesia in the treatment of pain ...

The aim of this study was to evaluate the effectiveness of intraoperative intercostal nerve cryolysis in terms of pain management in relation to the routinely ...

156. Efficacy of Intercostal Cryoanalgesia in Patients ...

Cryoanalgesia led to a significant reduction in oxycodone use during the first five post-operative days – important as the risk of long-term opioid use ...

Cryoanalgesia in Lung Transplantation – A Systematic ...

This meta-analysis indicates that cryoanalgesia effectively reduces opioid requirements and pain levels in lung transplant patients. Graphical ...

Opioid Requirements After Intercostal Cryoanalgesia in ...

Our results suggest that cryoanalgesia during thoracic surgery is associated with lower inpatient opioid requirements and postoperative pain for ...

Intercostal Cryoanalgesia in Double Lung Transplant ...

This study is testing a new way to help manage pain after a double lung transplant. Instead of relying only on strong pain medicines like ...

Intercostal cryoanalgesia for acute pain after video ...

This study aimed to assess the analgesic benefit of intercostal cryoanalgesia in VATS lung cancer surgery. The primary outcome was thoracic pain ...

AtriCure Announces Launch of cryoSPHERE MAX™ Probe ...

AtriCure's cryoICE cryoSPHERE® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac ...

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 ...