Stellate Ganglion Block for Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called stellate ganglion block to determine if it can reduce the risk of atrial fibrillation (an irregular heartbeat) after certain lung and esophagus surgeries. The treatment uses ultrasound to guide an injection of either bupivacaine or saline. Participants will be divided into two groups: one receiving bupivacaine and the other receiving saline. Individuals undergoing esophagectomy, pneumonectomy, or lobectomy surgeries might be suitable candidates for this trial. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.
Do I need to stop my current medications for the 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 is the safety track record for the Stellate Ganglion Block treatment?
Research has shown that the stellate ganglion block (SGB) with bupivacaine is generally well-tolerated. One study found that using ultrasound to guide the SGB is safe for patients, with no serious complications reported. However, minor side effects like neck pain, dizziness, or ringing in the ears can occur. These effects are usually temporary and manageable. While SGB has been used for a long time, some risks remain, such as the chance of a bruise from blood vessel injury. Overall, evidence suggests that SGB with bupivacaine is safe, but like any medical procedure, it carries some risks.12345
Why are researchers enthusiastic about this study treatment?
Unlike standard pain management options for surgery, such as general anesthesia or opioid medications, the Stellate Ganglion Block (SGB) targets a specific nerve cluster to potentially reduce pain and stress. Researchers are excited about SGB because it uses bupivacaine, a long-acting local anesthetic, to precisely block nerve signals via ultrasound guidance. This targeted approach may lead to fewer side effects and a more rapid recovery compared to traditional methods. Additionally, the use of a saline solution in a sham comparator group allows researchers to rigorously evaluate the true efficacy of the SGB technique.
What evidence suggests that the stellate ganglion block is effective for reducing postoperative atrial fibrillation?
Research shows that a stellate ganglion block, a nerve block in the neck using bupivacaine, can be very effective. In this trial, participants in Group 1 will receive the stellate ganglion block with bupivacaine, while Group 2 will receive a sham comparator with saline. Studies indicate that the stellate ganglion block reduces pain after surgery and stabilizes blood flow and pressure. For heart surgeries, it improves short-term outcomes, possibly by enhancing the body's stress management. Additionally, it has been shown to decrease heart rhythm problems, such as arrhythmias (irregular heartbeats), similar to atrial fibrillation (a fast heartbeat), which this study focuses on. Overall, the evidence supports its effectiveness in improving recovery after surgery and reducing complications.36789
Who Is on the Research Team?
Jacob Hutchins
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for patients aged 18-85 who are undergoing surgical procedures like esophagectomy, pneumonectomy, or lobectomy. It's not specified who can't join the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an ultrasound guided left sided stellate ganglion block with bupivacaine or saline during thoracic surgery
Follow-up
Participants are monitored for atrial fibrillation and other arrhythmias post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Stellate Ganglion Block
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor