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Compares treatment options for Post Operative Pain
Official title Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
ClinicalTrials.gov ID: NCT06349772
What this study is testing
What is Zynrelef?
Zynrelef is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for post operative pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age range: 18-65 years old
- Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
- Is able to provide written informed consent.
- Is able to adhere to the study visit schedule and complete all study assessments.
You likely can't join if
- Positive urine drug screen prior to surgery
- History of substance abuse in the past year-by self report
- Patient with ongoing daily narcotic use at the time of surgery-by self report
- Inability to understand informed consent or read English/Spanish
- Pregnant or lactating patients
- Prisoners
See the full eligibility criteria
- Age range: 18-65 years old
- Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
- Is able to provide written informed consent.
- Is able to adhere to the study visit schedule and complete all study assessments.
- Positive urine drug screen prior to surgery
- History of substance abuse in the past year-by self report
- Patient with ongoing daily narcotic use at the time of surgery-by self report
- Inability to understand informed consent or read English/Spanish
- Pregnant or lactating patients
- Prisoners
- Patients with renal or hepatic failure
- Bupivacaine use within 96 hours of operation
- Patient intolerant of opiates, nonsteroidal anti-inflammatory drug s, acetaminophen, or Zynrelef and Exparel. people in all cohorts must not have any contraindications to any of the protocol-specified drugs
- Patient with a 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
The study team makes the final eligibility decision.
Where it's taking place
- Lubbock, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lubbock, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.