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Last Updated: November 22, 2024

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CLINICAL TRIALS PROFILE FOR ZYNRELEF KIT


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All Clinical Trials for ZYNRELEF KIT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT05109312 ↗ A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE Recruiting Heron Therapeutics Phase 4 2021-10-18 This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.
NCT05188053 ↗ Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty Enrolling by invitation Mayo Clinic Phase 4 2022-01-01 The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
NCT05644496 ↗ ZYNRELEF for Pain Management in Total Knee Arthroplasty Not yet recruiting Baptist Health South Florida Phase 4 2023-01-01 The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement. The main questions it aims to answer are: - How well does the study drug control pain in the days after surgery? - Does the study drug reduce the amount of opioid analgesic consumed after surgery? Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam). Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.
NCT05863221 ↗ A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy Recruiting Heron Therapeutics Phase 4 2023-05-09 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: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.
NCT05863221 ↗ A Phase IV, Open-Label, Randomized, Active-controlled, Single-Center Study of ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy Recruiting Dr. Yannis Raftopoulos Phase 4 2023-05-09 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: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.
NCT06109415 ↗ A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Completed Heron Therapeutics Phase 4 2021-10-20 This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ZYNRELEF KIT

Condition Name

Condition Name for ZYNRELEF KIT
Intervention Trials
Analgesia 2
Postoperative Pain 2
Bariatric Surgery Candidate 1
Multimodal Analgesia 1
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Condition MeSH

Condition MeSH for ZYNRELEF KIT
Intervention Trials
Pain, Postoperative 3
Osteoarthritis, Knee 1
Acute Pain 1
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Clinical Trial Locations for ZYNRELEF KIT

Trials by Country

Trials by Country for ZYNRELEF KIT
Location Trials
United States 10
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Trials by US State

Trials by US State for ZYNRELEF KIT
Location Trials
Texas 3
Arkansas 2
Utah 1
Oklahoma 1
Massachusetts 1
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Clinical Trial Progress for ZYNRELEF KIT

Clinical Trial Phase

Clinical Trial Phase for ZYNRELEF KIT
Clinical Trial Phase Trials
Phase 4 6
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Clinical Trial Status

Clinical Trial Status for ZYNRELEF KIT
Clinical Trial Phase Trials
Completed 2
Recruiting 2
Enrolling by invitation 1
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Clinical Trial Sponsors for ZYNRELEF KIT

Sponsor Name

Sponsor Name for ZYNRELEF KIT
Sponsor Trials
Heron Therapeutics 4
Mayo Clinic 1
Baptist Health South Florida 1
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Sponsor Type

Sponsor Type for ZYNRELEF KIT
Sponsor Trials
Industry 4
Other 3
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