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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00533845
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Danny A Sherwinter, Maimonides Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: On-Q Pain Pump Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Study Start Date : September 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: On-Q pain pump
Bupivacaine
 Drug: On-Q Pain Pump
Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Other Name: Marcaine
Placebo Comparator: Placebo/control
Saline
 Drug: On-Q Pain Pump
Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Other Name: Marcaine


Outcome Measures
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Primary Outcome Measures :
  1. Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours [ Time Frame: 48 hours postop ]
    Pain assessment using a subjective pain visual analog scale VAS with cough at 48 hours. Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533845


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
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Principal Investigator: Danny A Sherwinter, MD Maimonides Medical Center
More Information
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Responsible Party: Danny A Sherwinter, Attending, Surgery, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00533845    
Other Study ID Numbers: 07/02/VA13
First Posted: September 24, 2007    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents