Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): On-Q Pain Pump
Intervention type(s): Drug
Intervention description(s): Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment