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NCT00638508 · ClinicalTrials.gov registry record · Phase 4
ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management
A Phase 4 study, sponsored by Maimonides Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 67
- Enrollment target
NCT00638508 is a Phase 4 study that has completed, run by Maimonides Medical Center. The registered enrollment target is 67 participants.
The verdict
NCT00638508, a Phase 4 study, has completed, sponsored by Maimonides Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 67 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ketorolac
- DRUG Ketorolac and Ropivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00638508
The ClinicalTrials.gov registry entry for NCT00638508 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Maimonides Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketorolac is the first listed.
NCT00638508 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00638508 about?
NCT00638508 is a clinical study titled "ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management". 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...
What is the current status of trial NCT00638508?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 67 participants. The study started on 2007-06. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00638508?
The interventions under investigation include: Ketorolac (DRUG), Ketorolac and Ropivacaine (DRUG).
Who is sponsoring clinical trial NCT00638508?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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