Zynrelef vs Exparel for Postoperative Pain

Overseen By Tommy Wright, DO

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Texas Tech University Health Sciences Center

Must not be taking: Narcotics, NSAIDs, Bupivacaine, others

Disqualifiers: Substance abuse, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate postoperative period

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which painkiller, Zynrelef or Exparel, works better after weight-loss surgery. Both are injectable treatments designed to manage post-surgical pain. Participants will receive one of these treatments during their robotic sleeve gastrectomy, and researchers will monitor their pain levels and use of pain medication afterward. Individuals undergoing this surgery with Dr. Goyal may be suitable candidates, particularly if they do not use narcotics daily or have had issues with NSAIDs in the past. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants the opportunity to contribute to groundbreaking pain management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using narcotics daily or have used bupivacaine within 96 hours before the surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Zynrelef and Exparel are safe and effective for managing post-surgical pain.

Zynrelef has been tested in over 1,067 patients undergoing various surgeries. Studies have found that using Zynrelef with a nerve block is safe, with only mild side effects reported, offering reassurance for those considering this option.

Exparel has also proven safe in studies, with no side effects reported. It provides effective pain relief after surgery, and one study showed it works well for several days.

Both treatments have FDA approval, indicating they have passed safety checks for other uses. For those considering joining a trial, these treatments have a strong safety record based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Zynrelef and Exparel for postoperative pain management because they offer innovative approaches to pain relief at surgical sites. Unlike traditional painkillers that often require systemic administration, both Zynrelef and Exparel are injected directly at the incision site, potentially reducing the need for oral opioids and their associated side effects. Zynrelef stands out due to its combination of bupivacaine and meloxicam, providing both local anesthetic and anti-inflammatory effects. Exparel, on the other hand, uses bupivacaine in a liposomal formulation for prolonged pain relief. These features make them promising candidates for enhancing patient comfort and recovery after surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare Zynrelef and Exparel for postoperative pain management. Research has shown that Zynrelef provides better pain relief for up to 72 hours after surgery compared to standard bupivacaine, a common local pain reliever. Patients using Zynrelef reported a 21% decrease in pain and required fewer opioids. In contrast, studies on Exparel have produced mixed results. While Exparel helps reduce the need for opioids, it hasn't consistently outperformed regular bupivacaine in pain relief. Overall, both treatments in this trial aim to manage postoperative pain with less reliance on opioids, but Zynrelef appears more effective at reducing pain. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 scheduled for robotic sleeve gastrectomy by Dr. Goyal, who can follow the study schedule and complete assessments. Participants must provide consent to join.

Inclusion Criteria

I can sign and understand the consent form.

I can attend all study visits and complete all required assessments.

I am scheduled for a weight loss surgery with Dr. Goyal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Zynrelef or Exparel at the closure site of robotic sleeve gastrectomy

Immediate postoperative period

1 visit (in-person)

Postoperative Monitoring

Participants' pain control is assessed using the NRS pain score up to 72 hours after surgery

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exparel
• Zynrelef

Trial Overview The study compares Zynrelef (bupivacaine with meloxicam) against Exparel (liposomal bupivacaine) for post-surgical pain control after surgery. Patients will be randomly assigned to one of these drugs and monitored up to 72 hours post-operation.

How Is the Trial Designed?

Group I: Patients who receive zynrelef Experimental Treatment 1 Intervention

Those who get zynrelef injected at the at the 12mm port incision

Group II: Patients who receive exparel Experimental Treatment 1 Intervention

those who get exparel injected at the 12mm port incision

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

Published Research Related to This Trial

HTX-011, an extended-release formulation of bupivacaine and meloxicam, offers effective postoperative pain control by releasing its active ingredients over 72 hours, which can enhance patient satisfaction after surgery.

This new formulation provides a longer duration of analgesia compared to traditional local anesthetics, while maintaining a favorable safety profile, making it a promising option in multimodal pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel long-acting local anesthetic - HTX-011 (ZYNRELEF&#8482;) for postoperative pain control. Kang, RS., Jin, Z., Gan, TJ.[2022]

Intravenous oxycodone was found to be more effective for managing acute postoperative pain compared to fentanyl and sufentanil, and it showed similar efficacy to morphine, based on a systematic review of 11 studies involving adult patients.

While oxycodone had a tendency for more side effects than fentanyl, its side effect profile was comparable to that of morphine and sufentanil, and patient satisfaction was generally higher with oxycodone compared to sufentanil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Oxycodone Versus Other Intravenous Strong Opioids for Acute Postoperative Pain Control: A Systematic Review of Randomized Controlled Trials. Raff, M., Belbachir, A., El-Tallawy, S., et al.[2020]

In a study of 68 adult patients undergoing surgery, intravenous parecoxib provided significantly better pain relief at rest compared to paracetamol, as measured by visual analog scores (VAS).

Both medications were found to be safe with infrequent adverse effects, and overall, patients reported higher satisfaction with pain management in the parecoxib group after 12 hours post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of intravenous paracetamol versus Parecoxib for postoperative analgesia after general anaesthesia. Gupta, K., Rastogi, B., Gupta, PK., et al.[2020]

A multimodal approach to postoperative pain management, combining regional analgesic techniques with non-opioid agents, can effectively reduce opioid use and improve patient comfort, potentially leading to better recovery outcomes.

Epidural analgesia provides strong pain relief and may enhance recovery of bowel function and rehabilitation, but it has not been shown to significantly reduce postoperative morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management and outcome after surgery. Bonnet, F., Marret, E.[2022]

Postoperative pain management is a significant global issue, with a need for improved strategies to prevent long-term complications like chronic pain disorders.

Personalized care and involving patients in their treatment decisions are essential steps toward enhancing acute pain management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling acute pain to improve the quality of postoperative pain management: an update from the European Society of Regional Anesthesia meeting held in Maastricht (September 2016). Andrés, J., Pogatzki-Zahn, E., Huygen, F., et al.[2019]

A review of 90 trials (31 for pregabalin and 59 for gabapentin) showed that only 24% adequately reported adverse events (AEs) at specified perioperative time points, highlighting a significant gap in safety assessment in post-operative pain treatment studies.

Only 7 out of 10 recommendations from the CONSORT Extension for Harms were typically followed, with 18% of trials not describing their AE assessment methods, indicating a need for improved reporting standards to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. Hoffer, D., Smith, SM., Parlow, J., et al.[2018]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2790975

Efficacy of Liposomal Bupivacaine and ... This study found that liposomal bupivacaine did not improve postoperative recovery or pain compared with bupivacaine hydrochloride alone among patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6032011/

Systematic review and meta-analysis of the efficacy of ... Specifically, the outcomes evaluated were length of stay, postoperative intravenous opioid use expressed in morphine equivalents, pain score ...

3. jss.amegroups.org jss.amegroups.org/article/view/5776/html

Liposomal bupivacaine does not decrease postoperative ... found that local infiltrations of LB with bupivacaine HCl demonstrated a 91% reduction in opioid consumption and 19% decrease in pain intensity ...

4. academic.oup.com academic.oup.com/bjs/article/111/Supplement_6/znae163.524/7743865

751 Efficacy of Liposomal Bupivacaine (Exparel) for Post ... Liposomal bupivacaine was shown to be safe and led to a reduction in post-operative opioid requirements compared to controls.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0099239916302904

Does Liposomal Bupivacaine (Exparel) Significantly ... The success rate was 29% for the liposomal group and 22% for the bupivacaine group, with no significant difference (P = .4684) between the groups. Liposomal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3772762/

Liposomal extended-release bupivacaine for postsurgical ... The double-blinded study found that the cumulative pain intensity scores through 4 days postsurgery were 20.7, 19.5, 18.8, and 19.1, for using EXPAREL® at doses ...

7. fda.gov fda.gov/files/advisory%20committees/published/FDA-Presentation-for-the-February-14-15--2018-Meeting-of-the-Anesthetic-and-Analgesic-Drug-Products-Advisory-Committee.pdf

NDA 022496, S009 EXPAREL Assessment of Efficacy Data ... Clinical studies using infiltration demonstrate that the PK profile of. EXPAREL varies by anatomical site of injection.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468428725000784

Liposomal bupivacaine infiltration for postprocedural ... The mean pain level was 4, 2, 2, and 2 on postoperative days 1, 2, 3, and 5, respectively. No side effects were noted. LB proved to be a safe and likely ...

9. aetna.com aetna.com/cpb/medical/data/900_999/0941.html

Bupivacaine Liposome (Exparel) - Medical Clinical Policy ... The authors concluded that Exparel PNBs resulted in decreases in pain levels, shorter hospital LOS, inpatient opioid usage, and improved WOMAC scores. These ...