Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Chang, Steve S., M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang, Steve S., M.D.
ClinicalTrials.gov Identifier:
NCT01530815
First received: February 8, 2012
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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 Intervention
Postoperative Pain
Drug: Bupivicaine Infusion

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chang, Steve S., M.D.:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    We will measure pain based on pain journal and usage of postoperative pain medication


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530815

Contacts
Contact: Steve Chang, MD 805-637-0217 s1chang@sbch.org

Locations
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
Principal Investigator: Steve S Chang, MD Santa Barbara Cottage Hospital
  More Information

No publications provided

Responsible Party: Chang, Steve S., M.D.
ClinicalTrials.gov Identifier: NCT01530815     History of Changes
Other Study ID Numbers: LapHernia_SBCH
Study First Received: February 8, 2012
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014