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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: Completed Phase 4 study, sponsored by Maimonides Medical Center.
NCT00638508 is a Phase 4 study that has completed, run by Maimonides Medical Center. The registered enrollment target is 67 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
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 |
What the finished NCT00638508 record still lists
NCT00638508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketorolac is the first listed.
NCT00638508 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00638508's enrollment target sits among peer trials
67 1083rd of 2000 higher than 918 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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