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Hernia, VentralNCT00472134

Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump

A study testing bupivacaine and On-Q PainBuster pump in people with Hernia, Ventral, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hernia, Ventral
What is being tested?
bupivacaine and On-Q PainBuster pump
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
Dec 2005to Dec 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Laparoscopic ventral hernia repair
  • Consent obtained

Who cannot join

  • Under 18 years
  • Allergic to Bupivacaine
  • significant liver or renal disease
  • Contraindication to PCA
  • Current daily opioid usage
  • History of substance abuse disorders
  • Dx of chronic pain syndrome
  • Daily usage of NSAIDs or COX 2 inhibitors

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

Other trials in United States

About this study

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 Repair.

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
Read the 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.

Conditions
Hernia, Ventral
Being tested
bupivacaine, On-Q PainBuster pump
Keywords
Hernia, Ventral, Laparoscopic Hernia Repair
Medical subject headings
Hernia, Ventral, Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bupivacaineDrug

    Also called Marcaine

    administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.

  • On-Q PainBuster pumpDevice

    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

Study groups in NCT00472134
Study groupRoleWhat they receive
Bupivicaine via Elastomeric pumpActive comparatorBupivicaine via elastomeric pump
Receives: Drug: bupivacaine
Placebo via elastomeric pumpPlacebo comparatorPlacebo via elastomeric pump
Receives: Device: On-Q PainBuster pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    Measured: 3 months

  2. Measuring: Visual Analog Pain Scale, Short-Form McGill Pain Questionnaire, Present Pain Intensity, Quantity of narcotic consumption

    Measured: 3 months

Secondary outcomes (2)
  1. Assess differences in postoperative pulmonary mechanics between the treated and nontreated groups by measuring the changes in maximal inspiratory volumes from baseline.

    Measured: 3 months

  2. The return of bowel function: Day of Flatus, Tolerating Regular Diet, Length of hospital stay

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2007 (estimated)
  2. Study startDec 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00472134
Sponsor's protocol ID
11-05-22
Status last verified
Jan 2012
First submitted
10 May 2007
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing bupivacaine and On-Q PainBuster pump in people with Hernia, Ventral, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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