Postoperative Pain Clinical Trial
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. 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®.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
| Recruiting |
NCT03181620 -
Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation
|
N/A | |
| Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
| Recruiting |
NCT06007378 -
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
|
N/A | |
| Recruiting |
NCT05943015 -
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
|
N/A | |
| Completed |
NCT04544228 -
Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
|
N/A | |
| Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
| Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
| Completed |
NCT03663478 -
Continuous TQL Block for Elective Cesarean Section
|
Phase 4 | |
| Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
| Completed |
NCT05170477 -
Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment
|
N/A | |
| Not yet recruiting |
NCT04561856 -
Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone
|
Phase 4 | |
| Completed |
NCT06425601 -
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
|
N/A | |
| Completed |
NCT03612947 -
TAP Block in Laparoscopic Cholecystectomy.
|
Phase 2 | |
| Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
| Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
| Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
| Active, not recruiting |
NCT04190355 -
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
|
N/A | |
| Recruiting |
NCT05145153 -
Incidence of Chronic Pain After Thoracic Surgery
|
||
| Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |