Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530815
Recruitment Status : Unknown
Verified February 2012 by Chang, Steve S., M.D..
Recruitment status was:  Recruiting
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):
Chang, Steve S., M.D.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivicaine Infusion Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intraoperative Local Anesthesia for Management of Postoperative Pain Following Laparoscopic Ventral Hernia Repair: a Prospective Double-blind Randomized Trial
Study Start Date : August 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Bupivicaine Infusion
We will infuse bupivicaine between the abdominal wall and mesh to try and reduce postoperative pain
 Drug: Bupivicaine Infusion
Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall
Other Name: Marcaine


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pain [ Time Frame: 24 hours ]
    We will measure pain based on pain journal and usage of postoperative pain medication


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530815


Contacts
Layout table for location contacts
Contact: Steve Chang, MD 805-637-0217 s1chang@sbch.org

Locations
Layout table for location information
United States, California
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Contact: Steve S Chang, MD    805-637-0217    s1chang@sbch.org   
Sponsors and Collaborators
Chang, Steve S., M.D.
Investigators
Layout table for investigator information
Principal Investigator: Steve S Chang, MD Santa Barbara Cottage Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Chang, Steve S., M.D.
ClinicalTrials.gov Identifier: NCT01530815    
Other Study ID Numbers: LapHernia_SBCH
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Hernia, Ventral
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Hernia
Pathological Conditions, Anatomical
 Hernia, Abdominal
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents