Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair
Intraoperative Local Anesthesia for Management of Postoperative Pain Following Laparoscopic Ventral Hernia Repair: a Prospective Double-blind Randomized Trial
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Aug 2011
Typical duration for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 8, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 10, 2012
February 1, 2012
1.4 years
February 8, 2012
February 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Pain
We will measure pain based on pain journal and usage of postoperative pain medication
24 hours
Study Arms (1)
Bupivicaine Infusion
EXPERIMENTALWe will infuse bupivicaine between the abdominal wall and mesh to try and reduce postoperative pain
Interventions
Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Related Publications (1)
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.
PMID: 26154700DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve S Chang, MD
Santa Barbara Cottage Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2012
First Posted
February 10, 2012
Study Start
August 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
February 10, 2012
Record last verified: 2012-02