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Local Anesthetic
ZYNRELEF® for Postoperative Pain (HeronBariatric Trial)
Phase 4
Recruiting
Led By Yannis Raftopoulos, MD
Research Sponsored by Dr. Yannis Raftopoulos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an American Society of Anesthesiologists Physical Status of I, II, or III
Is scheduled to undergo laparoscopic sleeve gastrectomy under general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
HeronBariatric Trial Summary
This trial will compare two treatments for pain relief after laparoscopic sleeve gastrectomy. One group will get ZYNRELEF® and the other just Ropivacaine and Dexamethasone, plus post-op IV acetaminophen.
Who is the study for?
This trial is for adults over 18 scheduled for laparoscopic sleeve gastrectomy. Participants must not be lactating, pregnant, or planning pregnancy; they should use reliable contraception if applicable. They can't have allergies to certain anesthetics or pain medications, recent local anesthetic use, systemic steroids within a specific timeframe before the study drug administration, coagulopathy, significant neuropathy, recent malignancy (except certain skin cancers), substance abuse history within six months, severe organ impairment or active infections like Hepatitis B/C or HIV.Check my eligibility
What is being tested?
The trial tests ZYNRELEF® (200 mg/6mg) combined with Ropivacaine and dexamethasone against standard treatment using just Ropivacaine and dexamethasone in managing postoperative pain after bariatric surgery. Both groups may receive IV acetaminophen as needed until discharge. The goal is to compare analgesia efficacy and duration between the two treatments.See study design
What are the potential side effects?
Possible side effects of ZYNRELEF® include reactions at the incision site such as redness or irritation, general discomforts like nausea and headaches could occur due to anesthesia-related drugs used during surgery.
HeronBariatric Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good enough for surgery according to the American Society of Anesthesiologists.
Select...
I am scheduled for a laparoscopic sleeve gastrectomy with general anesthesia.
HeronBariatric Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Discharge readiness assessment per the Modified Post Anesthetic Discharge Scoring System (MPADSS)
Opioid rescue medication use
Overall benefit of analgesia score (OBAS)
+4 moreSecondary outcome measures
ACE and PHQ scores
AEs from the time of drug application at surgery through Day 28.
Demographics with height, weight, and BMI calculation.
+2 moreHeronBariatric Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1Experimental Treatment1 Intervention
ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge.
Group II: Group 2Active Control1 Intervention
30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge.
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Who is running the clinical trial?
Dr. Yannis RaftopoulosLead Sponsor
Heron TherapeuticsIndustry Sponsor
27 Previous Clinical Trials
6,066 Total Patients Enrolled
10 Trials studying Postoperative Pain
2,699 Patients Enrolled for Postoperative Pain
Yannis Raftopoulos, MDPrincipal InvestigatorHolyoke Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not at risk of becoming pregnant or will use effective birth control during the study.Women who could become pregnant must have a negative pregnancy test before the study starts.I had heart bypass surgery within the last year.I have not abused drugs or alcohol in the last 6 months.I have had a serious heart issue or abnormal heart test results in the last 6 months.I have been part of a study for ZYNRELEF® or HTX-011 before.I have severe kidney problems or am on dialysis.I do not have severe liver problems.My blood does not clot properly, or I have uncontrolled blood thinning.I haven't had cancer in the last year, except for certain skin cancers or early-stage cervical cancer.My health is good enough for surgery according to the American Society of Anesthesiologists.I am a woman and meet specific health criteria.I have been given Ropivacaine within the last 5 days before my surgery.I have lost feeling in my hands or feet or have severe nerve pain.I haven't taken prescription steroids by mouth or injection within the last 10 days or 5 half-lives.I haven't been in a clinical trial or used an investigational product within the last 30 days or 5 half-lives.I am 18 years old or older.I have had 3 or more surgeries in the last year, not including diagnostic procedures.I have an active infection or am being treated for Hepatitis B, C, or HIV.I am scheduled for a laparoscopic sleeve gastrectomy with general anesthesia.You have had asthma or allergic reactions after taking aspirin or NSAIDs.I have not received any local anesthetic in the last 72 hours, except for specific minor exceptions.I am not allergic to specific pain medications and anesthetics listed in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being sought for this research endeavor?
"Correct. Information posted on clinicaltrials.gov verifies that this study is currently searching for participants. It was originally made public on May 9th 2023 and last updated on the same date, with an ambition to recruit 120 patients from one medical site."
Answered by AI
Has Group 1 been given the thumbs-up by the FDA?
"As this is a Phase 4 trial, which implies that Group 1's safety profile has been vetted and approved by relevant authorities, it was assigned a score of 3."
Answered by AI
How many participants have been accepted into this research initiative?
"Affirmative. Clinicaltrials.gov illustrates that this experiment is searching for 120 volunteers from one medical centre, with the initial posting being on May 9th 2023 and an update occurring around the same time."
Answered by AI
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