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Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump

This study has been completed.
Sponsor:
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00472134
First received: May 10, 2007
Last updated: June 14, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Condition Intervention
Hernia, Ventral
 Drug: bupivacaine
Device: On-Q PainBuster pump

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Measuring: Visual Analog Pain Scale, Short-Form McGill Pain Questionnaire, Present Pain Intensity, Quantity of narcotic consumption [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The return of bowel function: Day of Flatus, Tolerating Regular Diet, Length of hospital stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
randomized arm receiving bupivacaine via elastomeric pump
 Drug: bupivacaine
administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.
Other Name: Marcaine
Placebo Comparator: B
randomized arm receiving a placebo via elastomeric pump.
 Device: On-Q PainBuster pump
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 Name: On-Q PainBuster Pump

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laparoscopic ventral hernia repair
  • Consent obtained

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472134

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Michael J. Rosen, MD University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Michael Rosen, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00472134     History of Changes
Other Study ID Numbers: 11-05-22
Study First Received: May 10, 2007
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Hernia
Ventral
Laparoscopic Hernia Repair

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
Bupivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013