Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair
This study is currently recruiting participants.
Verified February 2012 by Chang, Steve S., M.D.
Sponsor:
Chang, Steve S., M.D.
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
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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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
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:
- 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
Contacts and Locations
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 May 22, 2013