Post Operative Pain, AcutePhase 4HeronBariatricNCT05863221
ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
A Phase 4 study testing ZYNRELEF 200Mg-6Mg Extended-Release Solution in people with Post Operative Pain, Acute and Bariatric Surgery Candidate, run by Dr. Yannis Raftopoulos at 1 site in United States.
Trial summary
Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio: Group 1: 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Acute, Bariatric Surgery Candidate, Postoperative Pain
- What is being tested?
- ZYNRELEF 200Mg-6Mg Extended-Release Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 9 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is able to provide written informed consent.
- Is able to adhere to the study visit schedule and complete all study assessments.
- Is male or female or other, and ≥18 years of age at screening.
- Is scheduled to undergo laparoscopic sleeve gastrectomy under general anesthesia
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- Female subjects are eligible only if all the following apply:
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- Not pregnant (female subjects of childbearing potential must have a negative urine pregnancy test at screening and on Day 1 before surgery).
- Not lactating.
- Not planning to become pregnant during the study.
- Is surgically sterile (eg, has had a bilateral tubal ligation); or is at least 2 years postmenopausal; or is in a monogamous relationship with a partner who is surgically sterile; or is practicing abstinence or agrees to use double-barrier contraception in the event of sexual activity; or is using an insertable, injectable, transdermal, or combination oral contraceptive approved by applicable regulatory authorities for greater than 2 months prior to screening and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days after study drug administration. Note: women in only a same-sex relationship do not need to meet this criterion.
Who cannot join
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to Ropivacaine (or other local anesthetics), meloxicam, acetaminophen, ketamine, fentanyl, hydromorphone or dexamethasone. Subjects in all cohorts must not have any contraindications to any of the protocol-specified drugs (Ropivacaine, bupivacaine, lidocaine, meloxicam, fentanyl, ketamine, acetaminophen, hydromorphone or dexamethasone).
- Has been administered Ropivacaine within 5 days prior to the scheduled surgery.
- Has been administered any local anesthetic within 72 hours prior to the scheduled surgery, other than for pretreatment prior to a needle placement, to treat an AE that occurs after signing the ICF, or to decrease venous irritation (eg, caused by propofol, in which case no more than a single administration of lidocaine 1% 20 mg IV may be administered).
- Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of the study drug (whichever is longer). Note that for purposes of this exclusion criterion, inhaled, ophthalmic, and over-the-counter steroids are not considered systemic.
- Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. Conditions may include but are not limited to, any of the following:
- History of asthma or urticarial/ allergic-type reactions after taking aspirin or NSAIDs.
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- History of clinically significant cardiac abnormality such as myocardial infarction within 6 months prior to signing the ICF, New York Heart Association class III or IV, or clinically significant abnormalities of electrocardiogram (ECG) or cardiac function.
- History of coronary artery bypass graft surgery within 12 months prior to signing the ICF.
- History of severe liver function impairment as defined by Child-Pugh Class C, having an aspartate aminotransferase >3 × the upper limit of normal (ULN) or having an alanine aminotransferase >3 × ULN.
- History of severe kidney function impairment as defined by creatinine clearance (Cockcroft-Gault) <30 mL/min, being on dialysis, and/or having a serum creatinine >2 × ULN.
- History of known or suspected coagulopathy or uncontrolled anticoagulation (PLT count <100,000/μL; hemoglobin <12 g/dL; or hematocrit <35%).
- Loss of sensation in extremities or significant peripheral neuropathy.
- As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
- Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments.
- Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Has a known or suspected history of drug abuse over the last 6 months, a positive drug screen on the day of surgery, or a recent history of alcohol abuse over the last 6 months. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor.
- Previously participated in a ZYNRELEF® or HTX-011 study.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives (whichever is longer) prior to surgery, or is planning to take part in another clinical trial while participating in this study.
- Has undergone 3 or more surgeries within 12 months prior to signing the Informed Consent Form, other than for diagnostic procedures (eg, colonoscopy)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Holyoke Medical Center
Holyoke, Massachusetts, 01040
Yannis Raftopoulos, MD, 413-535-4757, raftopoulos_ioannis@holyokehealth.com
Shruthi Rajkumar, MBBS, 4135354757, rajkumar_shruthi@holyokehealth.com
About this study
Official title: A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio:
Group 1: 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.
Read more
Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge.
Primary Objective:
To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy.
Secondary Objectives:
- To evaluate additional efficacy parameters, including opioid load, in this study population.
- To determine the impact of ZYNRELEF® on the cost of pain management.
- To assess the time taken to resume exercise after discharge.
- To assess the adverse events reported following the use of ZYNRELEF®.
- Being tested
- ZYNRELEF 200Mg-6Mg Extended-Release Solution
- Keywords
- Postoperative Pain, Bariatric Surgery, Opioid use
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYNRELEF 200Mg-6Mg Extended-Release SolutionDrug
ZYNRELEF® is an extended-release, fixed-ratio combination product that contains bupivacaine (a local anesthetic as the free base) and low-dose meloxicam (an NSAID) incorporated in a bioerodible polymer (termed Biochronomer®).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Drug: ZYNRELEF 200Mg-6Mg Extended-Release Solution |
| Group 2 | No intervention | 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores
Pain intensity scores using the NRS (either seated comfortably or lying down) on Day 0 before surgery, on arrival to the postanesthesia care unit(PACU), half hourly till departure from PACU, every 4 hours on the surgical floor until discharge on Postoperative Day 1 (POD1), then 48 hours,72 hours, Day 6 and Day 28.
Measured: 28 days
Opioid rescue medication use
Date, time of administration, and amount of all opioid rescue medication taken through 72 hours in morphine equivalents. Data from discharge to 72 hours will be collected over a phone call. Subject daily diary to record if any opioids or acetaminophen were taken from 72 hours through Day 28.
Measured: 28 days
Patient Global Assessment (PGA)
Patient Global Assessment (PGA) of pain control at 24, 48, and 72 hours, and on Day 28.
Measured: 28 days
Discharge readiness assessment per the Modified Post Anesthetic Discharge Scoring System (MPADSS)
Discharge readiness assessment per the Modified Post Anesthetic Discharge Scoring System (MPADSS) criteria at discharge on POD1
Measured: 24 hours
Subject's satisfaction with postoperative pain control
Subject's satisfaction with postoperative pain control at 24, 48, and 72 hours, and on Day 6 using a 5-point Likert scale.
Measured: 6 days
Overall benefit of analgesia score (OBAS)
Overall benefit of analgesia score (OBAS) at 24, 48, and 72 hours, and on Day 28.
Measured: 28 days
Time to Resume Exercise
Time taken to resume exercise after discharge in days. Subjects will be encouraged to report the time they resumed exercise. They will be asked at each communication as per the protocol.
Measured: 28 days
Secondary outcomes (5)
Demographics with height, weight, and BMI calculation.
Measured: 1 day
ACE and PHQ scores
Measured: 1 day
Medication history
Measured: 1 day
AEs from the time of drug application at surgery through Day 28.
Measured: 28 days
Episodes of nausea/vomiting and need for antiemetics postoperatively.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start9 May 2023
- Primary completion9 Oct 2024 (estimated)
- Study completion9 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase IV open-label, randomized, active-controlled study on subjects undergoing laparoscopic sleeve gastrectomy under general anesthesia.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Yannis Raftopoulos
- Sponsor type
- University, hospital or other
- Collaborators
- Heron Therapeutics
- Responsible party
- Sponsor-investigator, Dr. Yannis Raftopoulos, Holyoke Medical Center
- Investigators
- Yannis Raftopoulos, MD, Principal investigator, Holyoke Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863221
- Sponsor's protocol ID
- Heron Holyoke 1
- Acronym
- HeronBariatric
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected in this study, including data dictionaries, will not be available to other researchers after the end of the study to protect the privacy of the participant data. Data will be in a database in the hospital's private Bariatric Drive. In addition, this will be a password-protected file that can be accessed only by the Principal Investigator, Research Coordinator, and Research Assistant.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05863221
- Acronym / sponsor ID
- HeronBariatric / Heron Holyoke 1
- Keywords
- Postoperative Pain, Bariatric Surgery, Opioid use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. Yannis RaftopoulosUniversity, hospital or other
- Collaborators
- Heron Therapeutics
- Study start
- 9 May 2023 (actual)
- Primary completion
- 9 Oct 2024 (estimated)
- Study completion
- 9 Oct 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio:
Group 1: 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 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge.
Primary Objective:
To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy.
Secondary Objectives:
- To evaluate additional efficacy parameters, including opioid load, in this study population.
- To determine the impact of ZYNRELEF® on the cost of pain management.
- To assess the time taken to resume exercise after discharge.
- To assess the adverse events reported following the use of ZYNRELEF®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase IV open-label, randomized, active-controlled study on subjects undergoing laparoscopic sleeve gastrectomy under general anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ZYNRELEF 200Mg-6Mg Extended-Release SolutionZYNRELEF® 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 2 | No intervention | –30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is able to provide written informed consent.
- Is able to adhere to the study visit schedule and complete all study assessments.
- Is male or female or other, and ≥18 years of age at screening.
- Is scheduled to undergo laparoscopic sleeve gastrectomy under general anesthesia
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
Key exclusion criteria (19 listed)
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to Ropivacaine (or other local anesthetics), meloxicam, acetaminophen, ketamine, fentanyl, hydromorphone or dexamethasone. Subjects in all cohorts must not have any contraindications to any of the protocol-specified drugs (Ropivacaine, bupivacaine, lidocaine, meloxicam, fentanyl, ketamine, acetaminophen, hydromorphone or dexamethasone).
- Has been administered Ropivacaine within 5 days prior to the scheduled surgery.
- Has been administered any local anesthetic within 72 hours prior to the scheduled surgery, other than for pretreatment prior to a needle placement, to treat an AE that occurs after signing the ICF, or to decrease venous irritation (eg, caused by propofol, in which case no more than a single administration of lidocaine 1% 20 mg IV may be administered).
- Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of the study drug (whichever is longer). Note that for purposes of this exclusion criterion, inhaled, ophthalmic, and over-the-counter steroids are not considered systemic.
- Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. Conditions may include but are not limited to, any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZYNRELEF 200Mg-6Mg Extended-Release SolutionZYNRELEF® is an extended-release, fixed-ratio combination product that contains bupivacaine (a local anesthetic as the free base) and low-dose meloxicam (an NSAID) incorporated in a bioerodible polymer (termed Biochronomer®). | Drug | Group 1 |
Primary outcome
Postoperative Pain Scores
Time frame: 28 days
Pain intensity scores using the NRS (either seated comfortably or lying down) on Day 0 before surgery, on arrival to the postanesthesia care unit(PACU), half hourly till departure from PACU, every 4 hours on the surgical floor until discharge on Postoperative Day 1 (POD1), then 48 hours,72 hours, Day 6 and Day 28.
Opioid rescue medication use
Time frame: 28 days
Date, time of administration, and amount of all opioid rescue medication taken through 72 hours in morphine equivalents. Data from discharge to 72 hours will be collected over a phone call. Subject daily diary to record if any opioids or acetaminophen were taken from 72 hours through Day 28.
Patient Global Assessment (PGA)
Time frame: 28 days
Patient Global Assessment (PGA) of pain control at 24, 48, and 72 hours, and on Day 28.
Discharge readiness assessment per the Modified Post Anesthetic Discharge Scoring System (MPADSS)
Time frame: 24 hours
Discharge readiness assessment per the Modified Post Anesthetic Discharge Scoring System (MPADSS) criteria at discharge on POD1
Subject's satisfaction with postoperative pain control
Time frame: 6 days
Subject's satisfaction with postoperative pain control at 24, 48, and 72 hours, and on Day 6 using a 5-point Likert scale.
Overall benefit of analgesia score (OBAS)
Time frame: 28 days
Overall benefit of analgesia score (OBAS) at 24, 48, and 72 hours, and on Day 28.
Time to Resume Exercise
Time frame: 28 days
Time taken to resume exercise after discharge in days. Subjects will be encouraged to report the time they resumed exercise. They will be asked at each communication as per the protocol.
5 secondary outcomes
Demographics with height, weight, and BMI calculation.
Time frame: 1 day
ACE and PHQ scores
Time frame: 1 day
Medication history
Time frame: 1 day
AEs from the time of drug application at surgery through Day 28.
Time frame: 28 days
Episodes of nausea/vomiting and need for antiemetics postoperatively.
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected in this study, including data dictionaries, will not be available to other researchers after the end of the study to protect the privacy of the participant data. Data will be in a database in the hospital's private Bariatric Drive. In addition, this will be a password-protected file that can be accessed only by the Principal Investigator, Research Coordinator, and Research Assistant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannis Raftopoulos, MD principal investigator
Holyoke Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ZYNRELEF 200Mg-6Mg Extended-Release Solution in people with Post Operative Pain, Acute and Bariatric Surgery Candidate, run by Dr. Yannis Raftopoulos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shruthi Rajkumar, MBBS (4135354757, rajkumar_shruthi@holyokehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores (time frame: 28 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.