Nerve Blocks for Post-Surgical Pain After Cardiac Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two methods of managing pain after heart surgery. Researchers are examining two types of nerve blocks, the erector spinae plane (ESP) and pectoralis interfascial (PIF) blocks, to evaluate their effectiveness in controlling pain compared to not using any blocks. The goal is to determine if these blocks can reduce the need for pain medications like opioids after surgery. Individuals undergoing heart surgery with a midline chest incision, without a history of substance abuse or chronic opioid use, might be suitable for this trial. Participants will be randomly assigned to receive one of the treatments or none, and their pain levels and medication use will be monitored for 72 hours post-surgery. As an Early Phase 1 trial, this research aims to understand how these nerve blocks work in people, offering participants a chance to contribute to groundbreaking pain management strategies.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have a history of substance abuse or chronic opioid use, you may not be eligible to participate.
What prior data suggests that these nerve blocks are safe for post-surgical pain control?
Research shows that the ESP block is safe and effective for managing pain after certain surgeries. Studies have found that it significantly reduces pain and the need for opioids, common pain medications. It also does not seem to cause extra bleeding during surgery.
For the PIF block, a study that combined data from multiple sources found it reduces the need for opioids and helps patients recover faster after surgery. While more research is needed, these early findings suggest the PIF block is both effective and safe for managing pain.
Both blocks use bupivacaine, a local anesthetic that numbs the area. Although rare, there is a risk of the drug entering the bloodstream, which could lead to issues with the nervous system or heart. These risks are uncommon, and the treatments are generally well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these nerve block techniques for post-surgical pain after cardiac surgery because they offer a new way to manage pain with potentially fewer side effects than traditional options like opioids. The ESP block involves injecting a local anesthetic near the spine, which can provide broader pain relief by affecting multiple nerves. The PIF block, on the other hand, targets specific nerves around the chest area, potentially offering more focused pain relief. Both methods use ultrasound guidance, making them precise and minimizing the risk of complications. These techniques could reduce the need for opioids, which are often used but come with risks like addiction and side effects.
What evidence suggests that this trial's treatments could be effective for post-surgical pain after cardiac surgery?
In this trial, participants will be assigned to different groups to receive either an erector spinae plane (ESP) block, a pecto-intercostal fascial (PIF) block, or no block at all. Research has shown that ESP blocks can effectively reduce pain and the need for opioid painkillers after surgery. One study found that ESP blocks lowered opioid use and pain levels for patients post-surgery. Another study confirmed that ESP blocks helped manage pain for several months following surgery.
Similarly, PIF blocks have also proven effective. Research found that PIF blocks reduced the need for opioids and shortened the time patients required breathing support after surgery. Overall, both ESP and PIF blocks have shown promise in controlling pain and reducing reliance on pain medications after heart surgery.678910Who Is on the Research Team?
Himani Bhatt, D.O.
Principal Investigator
Mount Sinai West and Morningside Hospitals
Ali Shariat, M.D.
Principal Investigator
Mount Sinai West and Morningside Hospitals
Shenghao Fang, M.D.
Principal Investigator
Mount Sinai West and Morningside Hospitals
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 who are scheduled for cardiac surgery involving a sternotomy. It's open to all genders. People can't join if they're in critical health (ASA class V), need urgent surgery, have allergies to local anesthesia, can't consent, or have a history of substance abuse or chronic opioid use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Evaluation
Participants undergo pre-operative evaluation before surgery
Treatment
Participants receive either ESP block, PIF block, or no block during surgery
Post-operative Monitoring
Participants are monitored for opioid consumption and pain scores for 72 hours post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ESP block
- PIF block
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor