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®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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®).
Holyoke Medical Center
Holyoke, Massachusetts, United States
RECRUITINGPostoperative 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.
Time frame: 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.
Time frame: 28 days
Patient Global Assessment (PGA)
Patient Global Assessment (PGA) of pain control at 24, 48, and 72 hours, and on Day 28.
Time frame: 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
Time frame: 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.
Time frame: 6 days
Overall benefit of analgesia score (OBAS)
Overall benefit of analgesia score (OBAS) at 24, 48, and 72 hours, and on Day 28.
Time frame: 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.
Time frame: 28 days
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
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