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

NCT ID: NCT00533845

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-01-31

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

On-Q pain pump

Bupivacaine

Group Type: EXPERIMENTAL

On-Q Pain Pump

Intervention Type: DRUG

Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally

Placebo/control

Saline

Group Type: PLACEBO_COMPARATOR

On-Q Pain Pump

Intervention Type: DRUG

Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally

Interventions

On-Q Pain Pump

Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally

Intervention Type: DRUG

Other Intervention Names

Marcaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Danny A Sherwinter

Attending, Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danny A Sherwinter, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

07/02/VA13

Identifier Type: -

Identifier Source: org_study_id