The $19M question facing orthopedic trauma

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Orthopedic trauma surgeons are trained to fix what is broken.

Pain is expected to improve as the fracture stabilizes, swelling subsides and tissues heal. For many patients, it does. For some, it does not. Weeks after surgery, pain can become severe enough to interfere with physical therapy, motion and strength. Months later, it can persist alongside anxiety, depression, sleep disruption and continued opioid use.

Philipp Leucht, MD, PhD, and Jing Wang, MD, PhD, believe one of the field’s mistakes may be waiting too long to treat that trajectory as a problem.

“At the time of surgery is when the dice are rolled,” Dr. Leucht, an orthopedic trauma surgeon and vice chair of research in the orthopedic surgery department at New York City-based NYU Grossman School of Medicine, told Becker’s. “We need to just be multidisciplinary earlier rather than reactive later.”

That idea is now being put to a large test.

NYU Grossman researchers are leading K-POST, a seven-year, multicenter trial expected to enroll 1,800 patients undergoing surgery for serious orthopedic fractures. The study, approved for $19.67 million in funding from the Patient-Centered Outcomes Research Institute, will compare standard pain treatment with standard treatment plus a low-dose ketamine infusion during and after surgery.

The question is bigger than whether ketamine makes the first few postoperative days easier. Researchers want to know whether an intervention around the time of surgery can change a patient’s pain months later.

If it can, pain management after orthopedic trauma may need to move much closer to the beginning of care.

The fracture can heal while the pain problem grows

Pain after trauma changes throughout recovery. Dr. Leucht described an early phase driven by the initial injury to nerves and soft tissue. Inflammation then changes the character of the pain, and surgery creates another acute insult before symptoms begin to recede.

For many patients, that sequence resolves predictably, he said. But some, particularly those with lower-extremity injuries, follow a different path. Leg injuries are difficult to rest completely because patients depend on their lower extremities to move around. Swelling and dependency can worsen symptoms, and injuries around the foot and ankle can be particularly painful.

That makes early pain control consequential for reasons beyond comfort. “Anything we can do to help patients in this initial phase to get them off pain medication” matters, Dr. Leucht said, particularly because prolonged exposure can increase the risks associated with continued opioid use.

Dr. Wang, an anesthesiologist specializing in pain management and vice chair of research in NYU Grossman’s department of anesthesiology, sees another layer.

Dr. Wang said anxiety, depression, catastrophizing and, in some trauma patients, PTSD can exacerbate pain. Even as patients heal physically, processes in the nervous system and brain can continue to influence how they experience pain during recovery.

That dynamic can be particularly challenging after an unexpected injury. An elective surgery patient usually has time to prepare for an operation and recovery. A trauma patient may be injured suddenly, transported to a hospital and told they need an operation before they have  processed the initial injury.

“You have no time to prepare,” Dr. Leucht said. “You’re in this post-stress environment, and then you’re pushed to have another stressful event.”

The field calls the result pain. Dr. Leucht thinks that word may be too simple for what is actually happening.

Surgeons can often see trouble by six weeks

Severe acute postoperative pain is expected for the first few days, and inflammation can continue producing symptoms for another week or two.

Beyond that, Dr. Leucht starts paying attention to how patients behave around the injured extremity. If a patient returns at six weeks and withdraws when a physician approaches the leg, protects it intensely or experiences severe pain with light touch that should not be painful, he sees a warning.

“Something is off,” he said. A patient who is afraid to move may avoid therapy. The joint becomes stiff, muscle strength declines and recovery slows.

“That’s usually when I have to consider consulting pain specialists early on,” Dr. Leucht said. “Because you know this is going to result in an inferior outcome.”

But in practice, “early” can already be late. Dr. Leucht said access to pain specialists can involve waits of several months. K-POST is designed to challenge that gap: Instead of identifying a deteriorating pain trajectory weeks into recovery, could clinicians alter it at the time of surgery?

Acute pain may help set up chronic pain

Researchers cannot yet say exactly how much persistent pain is determined by what happens around an operation. There is, however, evidence linking more severe acute postoperative pain with a greater risk of chronic postsurgical pain.

“The more pain you have right after surgery, the more likely you are to develop chronic post-surgical pain,” Dr. Wang said.

The transition is not purely physical. Preoperative anxiety, depression and catastrophizing have also been associated with chronic postsurgical pain, he said. That makes the perioperative window especially important. Clinicians may have an opportunity not only to reduce pain, but also to prevent severe early symptoms from reinforcing disability and fear.

Even expectation-setting can matter. Dr. Wang said surgeons’ explanations of what patients should expect, how recovery will progress and what symptoms are normal can be part of that early intervention. K-POST will test whether medication can add another layer.

The study is looking past the recovery room

Ketamine has been used in anesthesiology for decades. At lower doses, it can also be used for pain management, and its effects on mood have made it particularly interesting as researchers explore the relationship among pain, anxiety and depression.

K-POST will randomize orthopedic trauma patients to standard pain treatment alone or standard treatment plus low-dose ketamine administered during and after surgery.

But the primary question will not be answered when the patient leaves the hospital. Researchers will repeatedly measure pain and its effect on patients’ lives. The primary outcome is pain at three months,  the threshold commonly used to distinguish chronic from acute pain.

“We really want to plot a pain trajectory,” Dr. Wang said. Pain remains unusually difficult to measure. There is no scan that tells a physician how much a patient hurts.

“We still live in the 19th century in this area,” Dr. Wang said. “We don’t have a really objective measure for pain.”

The trial will therefore look beyond a zero-to-10 pain score, using measures that assess how pain affects function, sleep, fatigue and other dimensions of daily life. That could determine whether ketamine simply makes patients more comfortable for several days or changes recovery itself.

The more important outcome may be whether patients move

For orthopedic surgeons, pain is clinically important partly because of what it prevents patients from doing. An anatomically successful repair does not automatically produce a successful recovery. Patients still have to regain motion, rebuild strength, tolerate weight-bearing when appropriate and participate in therapy.

Persistent pain can interfere with each step. That is why Dr. Leucht sees chronic pain prevention as more than a pain medicine question. A patient who remains fearful of movement and unable to participate fully in rehabilitation can experience a worse orthopedic outcome even if the fracture itself is healing correctly.

The implication: The quality of trauma care may depend partly on events outside the surgeon’s traditional focus on reduction, fixation and bone healing.

What if pain were treated like infection?

Dr. Wang offered an analogy for what preventive pain management could eventually look like. Orthopedic surgeons routinely use perioperative antibiotics even though most patients would never develop an infection without them. The intervention is justified because infection can be devastating and prophylaxis is relatively safe.

Persistent pain could someday be approached with similar logic. “We may be overtreating some patients,” Dr. Wang said. But if an intervention can reduce chronic pain among those who would develop it without harming those who would not, “that’s a great approach.”

“Here we’re trying to prevent pain,” he said. “It’s just as bad as an infection.”

K-POST will help determine whether ketamine deserves that role. Dr. Wang noted that the drug is inexpensive, familiar to anesthesiologists and routinely used clinically. Its potential effect on both pain and mood makes it particularly relevant to trauma patients. “If it’s effective, it should be kind of a game changer,” he said.

The trial will take years to answer that question. But the larger shift is already visible. Orthopedic trauma has traditionally treated persistent pain as a complication that becomes obvious later in recovery. Drs. Leucht and Wang are asking whether that is the wrong starting point.

By the time a patient is six weeks out, avoiding therapy and unable to tolerate movement, the process may already be well underway. The more consequential opportunity may be the hours surrounding the operation, before acute pain has the chance to become something much harder to reverse.

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

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