Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump
Condition: Hernia, Ventral
MeSH terms: Hernia; Hernia, Ventral
Study type: Interventional

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 description: 
      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.

      While the laparoscopic approach to ventral hernia repair has been documented as safe and
      effective, with low recurrence rates and minimal patient morbidity, some patients complain of
      significant post-operative pain for up to 1-3 months after surgery. The exact cause of this
      postoperative discomfort has not been clearly elucidated. Several hypotheses exist. Some feel
      that the extensive adhesiolysis required for incisional hernia repair causes significant
      peritoneal irritation that is exacerbated with the placement of intraperitoneal mesh. Others
      implicate the spiral tacks placed through the mesh into the peritoneum as sources of
      persistent discomfort. While others feel that the transabdominal fixation sutures are the
      localizing site for the accompanying postoperative pain. Transabdominal suture site pain
      after laparoscopic ventral hernia repair is not uncommon, and occurred in 23% of patients in
      one series.8 The transabdominal fixation suture sites are those incisions where sutures are
      placed to secure the mesh placed during laparoscopic ventral hernia repair to the anterior
      abdominal wall. The sutures are placed in a "clockwise" manner approximately every 4 to 5 cm
      at the periphery of the mesh as well as 5 mm spiral tacks to hold it in place until
      fibrocollagenous ingrowth secures the mesh to the abdominal wall. This persistent abdominal
      pain has been documented as a minor long-term complication resulting from laparoscopic
      ventral hernia repair, but it can be troublesome for patients in the immediate postoperative
      period.

      The most effective method for managing this postoperative pain has not been defined.

      The goal of postoperative care is to minimize the amount of pain a patient experiences
      following surgery and to help the patient make a quick recovery that leads to a shorter
      hospital stay free of complications and an earlier return to self-reliance. The most common
      treatment for pain after operation is opioid analgesic drug administration. Opioids are
      associated with undesirable side effects such as respiratory depression, nausea and vomiting,
      itching, increased duration of postoperative ileus, and delay in discharge. These side
      effects can be decreased with a reduction in the amount of opioid drugs utilized.
      Additionally, systemic narcotics may not optimize pain management in a specific region of the
      body because of its centralized effect. This may lead to a decreased mentation, reduced
      mobility, and a slower return to normal activities. Because a reduction of the daily
      consumption of narcotics is often associated with a decrease in analgesia, many other
      treatments for postoperative pain have been evaluated. For example, epidural analgesia is
      effective but the catheter needs to be placed preoperatively, is fairly invasive method, and
      the maintenance of the epidural treatment can be time consuming and expensive. Many studies
      have found clinical pain management benefits to the use of local analgesia, as measured by
      the use of less post-operative pain medication and more favorable ratings on pain intensity
      scales. Recently, a new method of delivering continuous wound infiltration with a solution of
      local anesthetic through an indwelling irrigation apparatus has been used in an attempt to
      reduce early postoperative discomfort in patients after thoracotomy, donor nephrectomy, and
      open inguinal hernia repair. These prospective randomized double blind studies universally
      report decreased postoperative discomfort and limited usage of opioids with the usage of
      these novel catheters.

      In this study, the goal is to minimize postoperative pain so that post-operative narcotic
      requirements will be unnecessary or required less frequently. The infusion of a local
      anesthetic immediately following the surgical procedure is intended to allow the body tissues
      to react more favorably to surgical stress and reduce early postoperative pain.

      The primary hypothesis is that continuous infusion of a local anesthetic along the edges of
      the mesh near the transabdominal fixation sutures and spiral tacks placed to secure mesh to
      the anterior abdominal wall will both subjectively and objectively improve postoperative pain
      control following laparoscopic ventral hernia repair. A secondary hypothesis is that
      pulmonary function and bowel function postoperatively will recover faster with the use of a
      continuous infusion of local anesthetic.
    

Intervention name(s): bupivacaine; On-Q PainBuster pump
Intervention type(s): Drug; Device
Intervention description(s): administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.; local anesthetic (bupivacaine) administered via a pain relief system consisting of a 20 gauge soaker catheter attached to an elastomeric balloon pump that is capable of infusing a set volume of local anesthetic over a wide area of surgical site for 2 to 5 days
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hernia; Ventral; Laparoscopic Hernia Repair