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Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danny A Sherwinter, Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00533845
First received: September 20, 2007
Last updated: May 25, 2013
Last verified: May 2013

September 20, 2007
May 25, 2013
September 2007
January 2010   (final data collection date for primary outcome measure)
Pain assessment using a subjective pain visual analog scale VAS, evaluation of narcotic requirements, presence of nausea and vomiting, and all side effects relatable to bupivicaine administration. [ Time Frame: 48 hours postop ] [ Designated as safety issue: No ]
Pain assessment using a subjective pain visual analog scale VAS, evaluation of narcotic requirements, presence of nausea and vomiting, and all side effects relatable to bupivicaine administration. [ Time Frame: 48 hours postop ]
Complete list of historical versions of study NCT00533845 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery

After Laparoscopic surgery most patients experience some form of mild to moderate pain. The current standard of care is to treat this pain with local anesthetics (numbing medication, that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic analgesics (medication injected into your vein to control pain such as morphine).

Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain control is rarely achieved and secondly, narcotics (such as morphine) often have many side effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset. All of these issues make recovery less comfortable and delays return to full function (work, school and other activities of daily life).

A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics. It consists of a pump that continuously infuses local anesthesia into and around the surgical site. This pump is placed during your operation. You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously.

The purpose of this study is to see if this pump improves postoperative pain, decreases the need for narcotic pain medicine and allows people to return to their activities earlier.

The procedure of the current study is to randomly assign patients undergoing minimally invasive surgeries (laparoscopic cholecystectomies and laparoscopic Lap-Banding procedures) to one of two groups. Both groups will have the standard surgical procedure performed and then at the completion will have the on-Q system placed in a subdiaphragmatic (within the abdomen) location. Half of the study group will have bupivicaine, a numbing medicine in the pump while the other half will have sterile saline in their pump. Neither the patient nor the surgeon will be aware of which group any particular patient is in, this is a process known as "blinding" and improves the reliability of the results. All patients will receive the standard locally infiltrated trocar site local anesthetic and either a prescription for Vicodin for ambulatory patients or morphine injected into their vein for patients staying in the hospital.

All patients will then be asked at preset intervals their level of pain the presence of nausea and their need for Vicodin or morphine. Ambulatory patients will be reached by phone for answers to these questions. All patients will have their pain controlled in the usual and standard way at all times. The On-Q pump will be removed at 48hours.

The results will then be statistically reviewed to see if the On-Q pumps were of benefit.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
Drug: On-Q Pain Pump
Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
  • Experimental: Bupivacaine
    On-Q pump containing Bupivacaine implanted
    Intervention: Drug: On-Q Pain Pump
  • Placebo Comparator: Placebo/control
    Saline used in the implanted On-Q device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less

Exclusion Criteria:

  • Patients who refuse consent
  • Are converted from laparoscopy to open surgery
  • Are allergic to bupivacaine
  • Are unable to followup
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00533845
07/04/IVA4
No
Danny A Sherwinter, Maimonides Medical Center
Maimonides Medical Center
Not Provided
Principal Investigator: Danny A Sherwinter, MD Maimonides Medical Center
Maimonides Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP