How Barnes-Jewish Hospital is rethinking pain & nausea management — 5 takeaways – Becker’s Hospital Review | Healthcare News
Postoperative nausea and vomiting (PONV) and pain remain some of the most significant dissatisfiers for surgical patients. During a recent session sponsored by Heron Therapeutics at Becker’s 22nd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, Rachel Wolfe, PharmD, clinical pharmacy specialist supervisor for perioperative medicine at Barnes-Jewish Hospital in St. Louis, detailed new strategies to address these challenges. She discussed extended-release local anesthetic options and innovative antiemetic therapies that can improve patient recovery and reduce opioid reliance.
Below are five takeaways from the session.
1. Extended-release anesthetics can bridge the postoperative pain gap.
Local anesthetics such as bupivacaine and ropivacaine have historically provided postoperative pain relief for up to 24 hours, after which additional analgesia, including opioids, is often necessary. Dr. Wolfe emphasized the importance of using non-opioid options whenever possible to limit patients’ exposure to opioids, which can lead to adverse effects such as constipation and sedation, as well as an increased risk of addiction and dependence.
“We know that inflammation and the patient’s surgical pain is typically the most intense in those first 72 hours,” Dr. Wolfe said. “So that leaves us with a huge efficacy gap as it relates to managing our patients’ pain.”
Dr. Wolfe described how ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use, is a dual-acting anesthetic that was developed to cover up to 72 hours of pain control.
The product is a viscous solution applied post-procedure at the surgical site, without a needle — “keeping needles off the sterile field, which is valuable these days,” Dr. Wolfe noted. It uses a biodegradable polymer to release medication gradually, aiming to improve pain scores, shorten discharge times and support enhanced recovery protocols.
2. Synergy between bupivacaine and meloxicam enhances effectiveness.
Inflammation at the surgical site can create an acidic environment that reduces the effectiveness of local anesthetics. Meloxicam serves a dual purpose: decreasing local inflammation and buffering the pH, which improves bupivacaine’s penetration into nerve membranes.
This concept was tested and reinforced through an animal model, Dr. Wolfe explained, which demonstrated synergy between meloxicam and bupivacaine. “This lasted through the 72-hour period — that’s how we know it is actually being effective as it relates to that synergistic reaction,” she said.
ZYNRELEF is FDA-approved for use in soft tissue and orthopedic procedures; however, its use in highly vascular surgeries, such as major spinal or intrathoracic procedures, has not been established for safety and efficacy.
3. Reimbursement pathways support adoption in outpatient surgical settings.
Beyond clinical performance, reimbursement is a key consideration for healthcare organizations. Dr. Wolfe said ZYNRELEF supports “broad access,” as it qualifies for Medicare reimbursement at average selling price plus 6% in ambulatory surgery centers and hospital outpatient departments, with 340B-pricing available.
“For our Medicare patients, it makes it a clear and easy decision to try to keep our patients, especially those that are elderly, away from opioids — from things that can actually impede their recovery,” Dr. Wolfe emphasized.
4. APONVIE® (aprepitant) injectable emulsion offers a single-dose solution for postoperative nausea and vomiting.
While extended pain relief is essential, Dr. Wolfe explained that nausea and vomiting can be just as disruptive to recovery. APONVIE, an intravenous form of the NK1 blocker aprepitant, is the first approved single-dose injection to prevent postoperative nausea and vomiting for up to 48 hours and has become a valuable tool at Barnes-Jewish Hospital.
“Now we have something in our toolbox that can actually be extremely effective for the management and prevention of postoperative nausea vomiting, and without the added side effects,” Dr. Wolfe said. “It’s not only significant to our patients, but it is significant to our facilities and employees as well — because if the patient is nauseous, we give them antiemetics and now they’re extremely sedated. That leads to throughput issues, overtime payments.”
APONVIE achieves more than 97% receptor occupancy within five minutes of administration and has no known risk of QT prolongation or sedation, a key differentiator from some existing antiemetics, Dr. Wolfe said.
5. PONV is a pervasive and largely unmet need in healthcare.
Postoperative nausea and vomiting are considered two of the biggest dissatisfiers in patients’ perioperative experience, Dr. Wolfe said. She underscored the urgent need for leaders to rethink and more deeply prioritize these areas — for the sake of patients and healthcare operations.
“We have tools in our toolbox to challenge ourselves and look at our behaviors and ask ourselves, ‘Should we be tolerating that patients have these experiences in their postoperative phase?’ We need to get them up, out of bed, moving, recovering. We all know that ERAS protocols — drinking, eating, mobility — are the most important things after surgery. If you’re nauseous, you’re not [doing any of that],” she said.
As surgical volumes continue to shift to outpatient settings, innovative products like ZYNRELEF and APONVIE offer clinicians new ways to improve pain and nausea management, reduce opioid dependence and enhance the overall perioperative experience.
ZYNRELEF Indication
ZYNRELEF is indicated in adults for instillation to produce postsurgical analgesia for up to 72 hours after soft tissue and orthopedic procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided.
Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large 4 or more level spinal, and head and neck procedures.
Important Safety Information
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Contraindications
ZYNRELEF is contraindicated in patients with a known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing CABG.
ZYNRELEF Important Safety Information (Cont.)
Warnings and Precautions
Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after application of ZYNRELEF. When using ZYNRELEF with other local anesthetics, overall local anesthetic exposure must be considered through 72 hours.
Hepatotoxicity: If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient.
Hypertension: Patients taking some antihypertensive medication may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid use of ZYNRELEF in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZYNRELEF in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal failure.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Risk of Joint Cartilage Necrosis and Degeneration with Unapproved Intra-articular Use: Animal studies evaluating the effects of ZYNRELEF following intra-articular administration in the knee joint demonstrated cartilage necrosis and degeneration.
Chondrolysis: Limit exposure to articular cartilage due to the potential risk of chondrolysis.
Methemoglobinemia: Cases have been reported with local anesthetic use.
Serious Skin Reactions: NSAIDs, including meloxicam, can cause serious skin adverse reactions. NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. If symptoms present, evaluate clinically.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): If symptoms are present, evaluate clinically.
Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus with NSAIDs, limit use of ZYNRELEF between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.
Hematologic Toxicity: Monitor hemoglobin and hematocrit in patients with any signs or symptoms of anemia.
Drug Interactions
Drugs That Interfere with Hemostasis: Monitor patients for bleeding who are using ZYNRELEF with drugs that interfere with hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs).
ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
ZYNRELEF Important Safety Information (Cont.)
Use in Specific Populations
Infertility: NSAIDs are associated with reversible infertility. Consider avoidance of ZYNRELEF in women who have difficulties conceiving.
Severe Hepatic Impairment: Only use if benefits are expected to outweigh risks; monitor for signs of worsening liver function.
Severe Renal Impairment: Not recommended.
Adverse Reactions
Most common adverse reactions (incidence ≥5%) in controlled clinical trials with ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache.
Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning and updated Warnings and Precautions for serious skin reactions caused by nonsteroidal anti-inflammatory drugs (NSAIDs) or visit www.zynrelef.com.
APONVIE Indication
APONVIE (aprepitant) is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
Limitations of Use: APONVIE has not been studied for treatment of established nausea and vomiting.
Important Safety Information
Contraindications
APONVIE is contraindicated in patients with a history of hypersensitivity to aprepitant or any component of the product, and in patients taking pimozide. Increased pimozide levels may cause serious or life-threatening reactions, such as QT prolongation.
Warnings and Precautions
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, during or soon after administration of aprepitant have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus, and wheezing have been reported. Monitor patients during and after administration. If hypersensitivity reactions occur, administer appropriate medical therapy. Do not administer APONVIE in patients who experienced these symptoms with previous use of aprepitant.
Clinically Significant CYP3A4 Drug Interactions: Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Use of pimozide, a CYP3A4 substrate, with APONVIE is contraindicated. Use of APONVIE with strong CYP3A4 inhibitors (eg, ketoconazole) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to APONVIE. Use of APONVIE with strong CYP3A4 inducers (eg, rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of APONVIE.
APONVIE Important Safety Information (Cont.)
Decrease in INR with Concomitant Warfarin: Use of aprepitant with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time. Monitor the INR in patients on chronic warfarin therapy in the 2-week period particularly at 7 to 10 days, following administration of APONVIE.
Risk of Reduced Efficacy of Hormonal Contraceptives: The efficacy of hormonal contraceptives may be reduced for 28 days following administration of APONVIE. Advise patients to use effective alternative or back-up methods of non-hormonal contraception for 1 month following administration of APONVIE.
Use in Specific Populations
Avoid use of APONVIE in pregnant women as alcohol is an inactive ingredient in APONVIE. There is no safe level of alcohol exposure in pregnancy.
Adverse Reactions
Most common adverse reactions (incidence ≥3%) for APONVIE are constipation, fatigue, and headache and for oral aprepitant are constipation and hypotension.
Report side effects to Heron at 1-844-437-6611 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information or visit www.aponvie.com.
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