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

Trial Summary

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.

What data supports the effectiveness of the drug Zynrelef for postoperative pain?

Research shows that Zynrelef, a combination of bupivacaine and meloxicam, is effective in controlling postoperative pain. This drug is part of a multimodal approach, which means it uses different methods together to manage pain better and improve patient satisfaction after surgery. ^{1 2 3 4 5}

What safety data exists for Zynrelef and Exparel in humans?

The research articles provided do not contain specific safety data for Zynrelef or Exparel in humans. ^{1 6 7 8 9}

How does the drug Zynrelef differ from other treatments for postoperative pain?

Zynrelef is unique because it combines bupivacaine, a local anesthetic, with meloxicam, an anti-inflammatory drug, in an extended-release formulation to provide long-lasting pain relief after surgery, reducing the need for opioids. ^{1 8 10 11 12}

What is the purpose of this trial?

The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A novel long-acting local anesthetic - HTX-011 (ZYNRELEF&#8482;) for postoperative pain control. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Postoperative pain management and outcome after surgery. [2022]

3. England 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). [2019]

4. France pubmed.ncbi.nlm.nih.gov

[Postoperative pain. Particularities in the child of less than 5 years, neonatology excluded]. [2019]

5. India pubmed.ncbi.nlm.nih.gov

Combined parecoxib and I.V. paracetamol provides additional analgesic effect with better postoperative satisfaction in patients undergoing anterior cruciate ligament reconstruction. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Intravenous Oxycodone Versus Other Intravenous Strong Opioids for Acute Postoperative Pain Control: A Systematic Review of Randomized Controlled Trials. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Sublingual Sufentanil in Pain Management After Pulmonary Resection: A Randomized Prospective Study. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Clinical evaluation of intravenous paracetamol versus Parecoxib for postoperative analgesia after general anaesthesia. [2020]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Sublingual sufentanil (Zalviso) patient-controlled analgesia after total knee arthroplasty: a retrospective comparison with oxycodone with or without dexamethasone. [2020]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Tramadol/Dexketoprofen Analgesic Efficacy Compared with Tramadol/Paracetamol in Moderate to Severe Postoperative Acute Pain: Subgroup Analysis of a Randomized, Double-Blind, Parallel Group Trial-DAVID Study. [2021]

12. India pubmed.ncbi.nlm.nih.gov

Patient-controlled epidural analgesia after thoracic and upper abdominal surgery using sufentanil with and without bupivacaine 0.125%. [2013]