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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02752230
• Other study ID #: 717168-2
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 29, 2016
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2020
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Laparoscopic Roux en Y gastric bypass
Laparoscopic Roux en Y gastric bypass
• Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kettering Health Network

References & Publications (5)

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. — View 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. — View 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. — View 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   CDC
•   Related Info