Comparison of Exparel to Marcaine in Post-Surgical Analgesia in Bariatrics

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine 0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of this study is to evaluate two local anesthetics and determine if there is an advantage of administering one medication compared over the other. The intent is show that one local anesthetic.allows for improved pain control as per the pain scale ratings of the test subjects.

Official Title
-----------------
Comparison of Exparel (Bupivacaine Liposome) to Marcaine (Bupivacaine) in Post-Surgical Analgesia for Laparoscopic Trocar Site Incisions in Bariatric Surgery

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Roux en Y gastric bypass
* Procedure: Laparoscopic Sleeve Gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Any patient scheduled to undergo Laparoscopic Roux en Y Gastric Bypass or Laparoscopic Gastric Sleeve with Dr. Stephen Fleischer Exclusion Criteria: Patients with an allergy to either medications being studied any patient with neurological disorders that may be exacerbated by the use of either medication,including multiple sclerosis and amyotrophic lateral sclerosis or that may impact the perception of pain. Patients with complex medical conditions that may confound data analysis per the principal investigator's discretion. Any pregnant patient.Any patients that would not like to participate in the study. Any patient that is not able to read or understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exparel (Bupivicaine Liposome)<br>Patient will have Exparel (Bupivicaine Liposome) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy. | Procedure: Laparoscopic Roux en Y gastric bypass<br>* Laparoscopic Roux en Y gastric bypass<br>Procedure: Laparoscopic Sleeve Gastrectomy<br>* Laparoscopic Sleeve Gastrectomy<br>|
| Active Comparator: Marcaine (Bupivicaine)<br>Patient will have Marcaine (Bupivicaine) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy. | Procedure: Laparoscopic Roux en Y gastric bypass<br>* Laparoscopic Roux en Y gastric bypass<br>Procedure: Laparoscopic Sleeve Gastrectomy<br>* Laparoscopic Sleeve Gastrectomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Post Operative Pain Level | Post operative pain will be assessed on an subjective level. The patient's pain will be assessed by the use of the Wong-Baker pain scale. | Within the first 10 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post operative pain, Bariatric Surgery