NCT02752230

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Longer than P75 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

November 29, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

March 31, 2016

Last Update Submit

July 13, 2020

Conditions

Post Operative Pain

Keywords

Post operative painBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Exparel (Bupivicaine Liposome)

ACTIVE COMPARATOR

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 bypassProcedure: Laparoscopic Sleeve Gastrectomy

Marcaine (Bupivicaine)

ACTIVE COMPARATOR

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 bypassProcedure: Laparoscopic Sleeve Gastrectomy

Interventions

Laparoscopic Roux en Y gastric bypassPROCEDURE

Laparoscopic Roux en Y gastric bypass

Exparel (Bupivicaine Liposome)Marcaine (Bupivicaine)
Laparoscopic Sleeve GastrectomyPROCEDURE

Laparoscopic Sleeve Gastrectomy

Exparel (Bupivicaine Liposome)Marcaine (Bupivicaine)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient scheduled to undergo Laparoscopic Roux en Y Gastric Bypass or Laparoscopic Gastric Sleeve with Dr. Stephen Fleischer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 23392233BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 10929992BACKGROUND

  • 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.

    PMID: 14599629BACKGROUND

  • 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.

    PMID: 15454134BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Lauren Smith

    Kettering Health Network

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 26, 2016

Study Start

November 29, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2021

Last Updated

July 15, 2020

Record last verified: 2020-07