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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Exparel (Bupivicaine Liposome)

Patient will have Exparel (Bupivicaine Liposome) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy.

Group Type ACTIVE_COMPARATOR

Laparoscopic Roux en Y gastric bypass

Intervention Type PROCEDURE

Laparoscopic Roux en Y gastric bypass

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy

Marcaine (Bupivicaine)

Patient will have Marcaine (Bupivicaine) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy.

Group Type ACTIVE_COMPARATOR

Laparoscopic Roux en Y gastric bypass

Intervention Type PROCEDURE

Laparoscopic Roux en Y gastric bypass

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy

Interventions

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Laparoscopic Roux en Y gastric bypass

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes