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NCT00136682 · ClinicalTrials.gov registry record · Phase 3
Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery
A Phase 3 study of Postoperative Pain, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT00136682 is a Phase 3 study of Postoperative Pain that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 240 participants, roughly in line with the 228-participant average among 63 other Postoperative Pain trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00136682, a Phase 3 study of Postoperative Pain, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
Recovery after major abdominal surgery can be longer than other types of surgery. This is because often after abdominal surgery, the bowel does not work normally. When this happens, patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These symptoms are called postoperative ileus. We, the researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), are doing this study to compare two methods of treating pain during and after major gynecological surgery. The two methods are called patient-controlled epidural analgesia (PCEA) and patient-controlled intravenous analgesia (PCA). PCA is the standard of care for women having major gynecological surgery. We are going to compare PCEA to PCA to see if PCEA will improve recovery after major gynecologic surgery. PCEA is a well established method used to ease pain in many settings such as during childbirth and bowel surgery. There have been several studies showing that PCEA is as good as and sometimes better for pain relief than PCA. PCEA may help the bowel work better by preventing ileus after surgery. However, this has never been looked at in women having major gynecologic surgery. This study will also look at whether preventing this ileus will lead to patients going home or returning to regular activities sooner.
Conditions Studied
Interventions
- DRUG patient-controlled epidural analgesia (PCEA)
- DRUG patient-controlled intravenous analgesia (PCA)
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2004-08 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00136682
The ClinicalTrials.gov registry entry for NCT00136682 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 228-participant average among 63 other Postoperative Pain trials with a reported enrollment target. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which patient-controlled epidural analgesia (PCEA) is the first listed.
NCT00136682 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00136682 about?
NCT00136682 is a clinical study titled "Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery". Recovery after major abdominal surgery can be longer than other types of surgery. This is because often after abdominal surgery, the bowel does not work normally. When this happens, patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These symptoms are called posto...
What is the current status of trial NCT00136682?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2004-08. Estimated completion is 2007-07.
What conditions does trial NCT00136682 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT00136682?
The interventions under investigation include: patient-controlled epidural analgesia (PCEA) (DRUG), patient-controlled intravenous analgesia (PCA) (DRUG).
Who is sponsoring clinical trial NCT00136682?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00136682 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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