Jennifer Byrne , 2025-04-25 18:00:00
April 25, 2025
3 min read
Key takeaways:
- The trial will compare administration techniques and timing of two approaches for managing mastectomy-related pain.
- The study also aims to reduce the need for opioids after these procedures.
A multidisciplinary team of researchers at University of Cincinnati Cancer Center is conducting a clinical trial to identify an optimal pain management strategy for patients undergoing mastectomy.
Investigators hope the study also yields insights that will help reduce the need for opioids.
Alicia A. Heelan, MD, breast surgical oncologist and assistant professor of surgery, and Bradley M. Budde, MD, associate professor of clinical anesthesiology, will lead the trial.
A $50,000 pilot grant backed by contributions from Ride Cincinnati through the Cancer Center Pilot Project Award program will support the effort.
The trial will enroll approximately 100 patients. Investigators will randomly assign them to receive a pectoralis nerve block — commonly known as a PECS block — containing bupivacaine or liposomal bupivacaine (Exparel, Pacira Biosciences), both of which are FDA approved. In addition to comparing the two strategies, researchers will assess whether timing — before surgery or during — affects outcomes.
Patients undergoing single or double mastectomy are eligible to enroll, regardless of whether they are pursuing reconstruction. Participants also will receive nonopioid analgesic medications such as acetaminophen or ibuprofen before and after surgery for pain.
In addition to determining an optimal pain control strategy, the researchers will assess patient satisfaction and evaluate how the different combinations affect time of surgery and length of hospital stay, among other factors.
PECS blocks can be administered by anesthesiologists via ultrasound guidance before surgery or by the surgeon after mastectomy. Both approaches and drugs are considered standards of care, but no study to date has assessed the optimal combination for managing pain among these patients.
“Bupivacaine has been around since the 1950s, and Exparel has been around for about 10 years, and there are questions about which is best. I also know that each of us has our biases in terms of technique,” Budde told Healio. “If it’s all equivalent, that’s also a good answer to have. We can then share with people that if they’re doing any of these, they’re doing the right thing for the patients.”
Healio spoke with Budde and Heelan about current practices for pain management, the motivation for this study and the potential implications of the results.
Healio: What is the current standard of care for pain management for people undergoing mastectomy?
Heelan: The current standard is multimodal analgesia, which includes the use of oral and IV medications before and after surgery to help prevent pain. Depending on where the patient is receiving treatment, it can also include a nerve block. Most often, it includes multimodal, oral pain control after surgery through a combination of nonopioid medications like [acetaminophen] and ibuprofen, and opioid medications like oxycodone or tramadol.
These are the standards of care, but they’re done by provider preference. They’re guided by whatever the surgeon or anesthesiologist at a particular center’s preference is.
Healio: What motivated you to study pain management in this context?
Budde: When Dr. Heelan and I began working together, we realized we had both come from training facilities with different practice patterns. I came from an institution where anesthesiologists had done the nerve blocks under ultrasound guidance preoperatively with certain medications. She came from training where surgeons did similar nerve blocks, but used a different technique. We became curious about which medication, technique and timing of these measures work best.
We are hoping to get an answer to this with our study — that way we can share this with our colleagues who are approaching this in different ways. We also wanted to find ways to reduce the reliance on perioperative opioids for these patients.
Healio: Could you describe the study design?
Heelan: It’s a two-phase study, and we are enrolling for our first phase now. In the first phase, we’re doing the blocks with an intraoperative technique, meaning they are done after the breast tissue has been removed but before the surgery is over. That’s where I directly visualize the nerve and inject the medication around the nerves and into the structures. In this first phase, we are evaluating whether Exparel is more or less effective — or equivalently effective — to bupivacaine.
The second phase of the study will look at the timing of the block and whether that improves or changes the pain control. This includes having the block administered by regional anesthesiologists before the surgery under ultrasound guidance to stop the pain before it potentially starts, rather than during the surgery.
Healio: What insights do you hope to gain?
Budde: We’re not really doing anything experimental here — these medications and techniques are all standard of care. We just want to compare them to see which is the best. In these times, with technology that enables ideas to move much faster, we think it’s important for providers to understand all the options available for this particular aspect of pain control for patients undergoing mastectomy, and know which are optimal.
Heelan: I love that the study is clinically applicable in a short timeframe.
We hope this study will also allow us to identify populations that might need more or less opioids after surgery.
For more information:
Brad M. Budde, MD, can be reached at buddebm@ucmail.uc.edu.
Alicia A. Heelan, MD, can be reached at heelanaa@ucmail.uc.edu.
