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
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: On-Q Pain Pump
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine
On-Q pump containing Bupivacaine implanted
Drug: On-Q Pain Pump
Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Placebo Comparator: Placebo/control
Saline used in the implanted On-Q device

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533845

Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Danny A Sherwinter, MD Maimonides Medical Center
  More Information

No publications provided

Responsible Party: Danny A Sherwinter, Attending, Surgery, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00533845     History of Changes
Other Study ID Numbers: 07/04/IVA4
Study First Received: September 20, 2007
Last Updated: May 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014