Clinical Trial: Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective, Randomized, Double-blind Trial of Continuous Infusion of 0.5% Bupivacaine be Elastomeric Pump for Prospective Pain Management After Laparoscopic Ventral Hernia

Brief Summary:

The purpose of this study is to determine the effects of a local anesthetic dispensed via a tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the mesh used in the laparoscopic repair of ventral hernias. The goals are:

  • reducing postoperative pain from this procedure
  • decreasing length of hospital stay
  • reducing or eliminating amount of post-operative narcotics used

Detailed Summary:

One outcome of the greater than 2 million abdominal operations performed in the United States each year is an incisional hernia rate of 3% to 20%. As a result, approximately 150,000 ventral hernia repairs are performed annually. The increasing number of incisional hernias merely reflects the evolution of surgery with the ability to perform larger abdominal operations such as aortic surgery and colectomy. Primary tissue repairs have had unacceptable rates of recurrence when used for larger defects. The introduction of prosthetic biomaterials revolutionized hernia surgery with the concept of a tension-free repair. The subsequent rate of recurrence has been lowered to less than 10%. However, the required dissection of wide areas of soft tissue for mesh placement contribute to an incidence of wound infections and wound-related complications of 12% or greater. These problems were part of the impetus to develop minimally invasive techniques for ventral herniorrhaphy.

The laparoscopic repair of ventral hernias is rapidly evolving with patient and surgeon interest in less morbid herniorrhaphies and the appeal of minimally invasive surgery. The technique is based on the open, preperitoneal repair described by Rives and Stoppa. The placement of a large mesh in the preperitoneal location allows for an even distribution of forces along the surface area of the mesh, which may account for the strength of the repair and the decreased recurrence rates associated with it. The minimally invasive approach embraces the concept that a retromuscular mesh repair may be more durable, although the mesh is placed one layer deeper on an intact peritoneum in comparison to the open technique. The technique incorporates other fundamental components of the open repair such as wide mesh overlap of the defect and the use of transabdominal fixation sutures and spiral tacks to secure the mesh.

Sponsor: University Hospitals Cleveland Medical Center

Current Primary Outcome:

  • Place an elastomeric infusion catheter superficial to the mesh at the conclusion of the laparoscopic ventral hernia repair and compare the following to a group that receives a placebo infusion of saline: [ Time Frame: 3 months ]
  • Measuring: Visual Analog Pain Scale, Short-Form McGill Pain Questionnaire, Present Pain Intensity, Quantity of narcotic consumption [ Time Frame: 3 months ]


Original Primary Outcome:

  • Place an elastomeric infusion catheter superficial to the mesh at the conclusion of the laparoscopic ventral hernia repair and compare the following to a group that receives a placebo infusion of saline:
  • Measuring: Visual Analog Pain Scale, Short-Form McGill Pain Questionnaire, Present Pain Intensity, Quantity of narcotic consumption


Current Secondary Outcome:

  • Assess differences in postoperative pulmonary mechanics between the treated and nontreated groups by measuring the changes in maximal inspiratory volumes from baseline. [ Time Frame: 3 months ]
  • The return of bowel function: Day of Flatus, Tolerating Regular Diet, Length of hospital stay [ Time Frame: 1 week ]


Original Secondary Outcome:

  • Assess differences in postoperative pulmonary mechanics between the treated and nontreated groups by measuring the changes in maximal inspiratory volumes from baseline.
  • The return of bowel function: Day of Flatus, Tolerating Regular Diet, Length of hospital stay


Information By: University Hospitals Cleveland Medical Center

Dates:
Date Received: May 10, 2007
Date Started: December 2005
Date Completion:
Last Updated: June 4, 2015
Last Verified: January 2012