Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472134
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2007-05-10
Brief Title:
Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Prospective Randomized Double-blind Trial of Continuous Infusion of 05 Bupivacaine be Elastomeric Pump for Prospective Pain Management After Laparoscopic Ventral Hernia Repair
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 150000 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 series8 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
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 series8 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None