ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which can cause side effects such as sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects of morphine. Recently a portable device called ON-Q pump has been developed to continuously infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses the drug through the catheters by elastic force. This pump is very safe and is attached to a bedside pole or the patient's hospital gown. This pump has already been approved by the FDA for clinical use, and has been reported to provide effective pain management after some surgical procedures.

The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used for post operative pain relief. Our hypothesis is that these two drugs in combination will provide better analgesia than Ketorolac alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimonides Medical Center
• Collaborator: I-Flow
• Treatments: Ketorolac; Ketorolac Tromethamine; Ropivacaine

Criteria

Inclusion Criteria:

• Patients belonging to ASA class I to II classification who are undergoing abdominal gynecologic surgery will be included in the study.

Exclusion Criteria:

• Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer, sepsis, or coagulation problems will be excluded from the study.