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NCT00533845 · ClinicalTrials.gov registry record · Phase 4
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
A Phase 4 study, sponsored by Maimonides Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00533845 is a Phase 4 study that has completed, run by Maimonides Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT00533845, a Phase 4 study, has completed, sponsored by Maimonides Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG On-Q Pain Pump
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00533845
The ClinicalTrials.gov registry entry for NCT00533845 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 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 1 intervention - of which On-Q Pain Pump is the first listed.
NCT00533845 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00533845 about?
NCT00533845 is a clinical study titled "Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery". 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 i...
What is the current status of trial NCT00533845?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2007-09. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00533845?
The interventions under investigation include: On-Q Pain Pump (DRUG).
Who is sponsoring clinical trial NCT00533845?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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