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

Kettering Health Network

Status and phase: Withdrawn; Phase 4

Conditions: Post Operative Pain

Treatments: Procedure: Laparoscopic Sleeve Gastrectomy; Procedure: Laparoscopic Roux en Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT02752230

717168-2

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Exparel (Bupivicaine Liposome)

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic Sleeve Gastrectomy

Procedure: Laparoscopic Roux en Y gastric bypass

Marcaine (Bupivicaine)

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic Sleeve Gastrectomy

Procedure: Laparoscopic Roux en Y gastric bypass