Back to resultsComparison of Exparel to Marcaine in Post-Surgical Analgesia in Bariatrics
Primary Purpose
Post Operative Pain
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Laparoscopic Roux en Y gastric bypass
Laparoscopic Sleeve Gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Post operative pain, Bariatric Surgery
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Exparel (Bupivicaine Liposome)
Marcaine (Bupivicaine)
Arm Description
Patient will have Exparel (Bupivicaine Liposome) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy.
Patient will have Marcaine (Bupivicaine) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02752230
Brief Title
Comparison of Exparel to Marcaine in Post-Surgical Analgesia in Bariatrics
Official Title
Comparison of Exparel (Bupivacaine Liposome) to Marcaine (Bupivacaine) in Post-Surgical Analgesia for Laparoscopic Trocar Site Incisions in Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Attending physician left network
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kettering Health Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Post operative pain, Bariatric Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel (Bupivicaine Liposome)
Arm Type
Active Comparator
Arm Description
Patient will have Exparel (Bupivicaine Liposome) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy.
Arm Title
Marcaine (Bupivicaine)
Arm Type
Active Comparator
Arm Description
Patient will have Marcaine (Bupivicaine) injected at Laparoscopic Port sites during the Laparoscopic Roux en Y or Laparoscopic Sleeve Gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Roux en Y gastric bypass
Intervention Description
Laparoscopic Roux en Y gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Sleeve Gastrectomy
Intervention Description
Laparoscopic Sleeve Gastrectomy
Primary Outcome Measure Information:
Title
Subjective Post Operative Pain Level
Description
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.
Time Frame
Within the first 10 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Smith
Organizational Affiliation
Kettering Health Network
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23392233
Citation
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
Results Reference
background
Citation
McGee, DL. Local and topical anesthesia in clinical procedures in Emergency Medicine, 5th edition, Roberts, JR, 263Hedges, JR(Eds), Saunders Elsevier, Philadelphia 2010, pg. 481
Results Reference
background
PubMed Identifier
10929992
Citation
Weingart SN, Iezzoni LI, Davis RB, Palmer RH, Cahalane M, Hamel MB, Mukamal K, Phillips RS, Davies DT Jr, Banks NJ. Use of administrative data to find substandard care: validation of the complications screening program. Med Care. 2000 Aug;38(8):796-806. doi: 10.1097/00005650-200008000-00004.
Results Reference
background
PubMed Identifier
14599629
Citation
Fleischmann KE, Goldman L, Young B, Lee TH. Association between cardiac and noncardiac complications in patients undergoing noncardiac surgery: outcomes and effects on length of stay. Am J Med. 2003 Nov;115(7):515-20. doi: 10.1016/s0002-9343(03)00474-1.
Results Reference
background
PubMed Identifier
15454134
Citation
Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA Jr. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg. 2004 Oct;199(4):531-7. doi: 10.1016/j.jamcollsurg.2004.05.276.
Results Reference
background
Links:
URL
http://cdc.org
Description
CDC
URL
http://Uptodate.com
Description
Related Info
Learn more about this trial
Comparison of Exparel to Marcaine in Post-Surgical Analgesia in Bariatrics
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