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Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivicaine Infusion
Sponsored by
Chang, Steve S., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient must be scheduled for a laparoscopic ventral hernia repair at SBCH. If any additional procedure is performed, the subject will be excluded from the study
  2. Age 18 or older
  3. Patient must agree to complete pain journal postoperatively
  4. Informed consent signed and dated by patient. Consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal

Exclusion Criteria:

  1. Any surgical procedure occurring besides the study procedure
  2. Any allergy or sensitivity to bupivicaine or its derivatives
  3. Less than 18 years of age
  4. Patient unable to self report in pain journal due to cognitive disabilities
  5. Discharged less than 4 hours post-surgery

Sites / Locations

  • Santa Barbara Cottage HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bupivicaine Infusion

Arm Description

We will infuse bupivicaine between the abdominal wall and mesh to try and reduce postoperative pain

Outcomes

Primary Outcome Measures

Pain
We will measure pain based on pain journal and usage of postoperative pain medication

Secondary Outcome Measures

Full Information

First Posted
February 8, 2012
Last Updated
February 9, 2012
Sponsor
Chang, Steve S., M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01530815
Brief Title
Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair
Official Title
Intraoperative Local Anesthesia for Management of Postoperative Pain Following Laparoscopic Ventral Hernia Repair: a Prospective Double-blind Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang, Steve S., M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators are testing to see if infusion of bupivicaine between the mesh and abdominal wall can reduce postoperative pain and decrease use of narcotics in the postoperative setting.
Detailed Description
The primary objective of this study is to test different methods for pain management following laparoscopic ventral hernia repair. We hypothesize that local analgesic injection between the abdominal wall and mesh intraoperatively during laparoscopic ventral hernia repair will result in a 20% decrease in the use of post-surgery pain medication in the first four hours after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivicaine Infusion
Arm Type
Experimental
Arm Description
We will infuse bupivicaine between the abdominal wall and mesh to try and reduce postoperative pain
Intervention Type
Drug
Intervention Name(s)
Bupivicaine Infusion
Other Intervention Name(s)
Marcaine
Intervention Description
Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall
Primary Outcome Measure Information:
Title
Pain
Description
We will measure pain based on pain journal and usage of postoperative pain medication
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be scheduled for a laparoscopic ventral hernia repair at SBCH. If any additional procedure is performed, the subject will be excluded from the study Age 18 or older Patient must agree to complete pain journal postoperatively Informed consent signed and dated by patient. Consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal Exclusion Criteria: Any surgical procedure occurring besides the study procedure Any allergy or sensitivity to bupivicaine or its derivatives Less than 18 years of age Patient unable to self report in pain journal due to cognitive disabilities Discharged less than 4 hours post-surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Chang, MD
Phone
805-637-0217
Email
s1chang@sbch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve S Chang, MD
Organizational Affiliation
Santa Barbara Cottage Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve S Chang, MD
Phone
805-637-0217
Email
s1chang@sbch.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
26154700
Citation
Gough AE, Chang S, Reddy S, Ferrigno L, Zerey M, Grotts J, Yim S, Thoman DS. Periprosthetic Anesthetic for Postoperative Pain After Laparoscopic Ventral Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2015 Sep;150(9):835-40. doi: 10.1001/jamasurg.2015.1530.
Results Reference
derived

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Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

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