Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer
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|ClinicalTrials.gov Identifier: NCT00295945|
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : May 20, 2014
RATIONALE: Giving pain medication into the space between the wall of the spinal canal and the covering of the spinal cord or giving it into a vein may help lessen pain caused by cancer surgery. It is not yet known whether epidural analgesia is more effective than patient-controlled analgesia in controlling pain in patients who have undergone surgery for gynecologic cancer.
PURPOSE: This randomized clinical trial is studying epidural analgesia to see how well it works compared to patient-controlled analgesia in treating patients who have undergone surgery for gynecologic cancer.
|Condition or disease||Intervention/treatment|
|Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Pain Perioperative/Postoperative Complications Sarcoma||Drug: fentanyl citrate Drug: hydromorphone hydrochloride Drug: ropivacaine hydrochloride|
- Determine whether the gradual weaning of an epidural opioid can shorten the duration of postoperative ileus, without worsening pain control, in patients who have undergone surgery for gynecologic cancer.
- Compare postoperative pain management in patients treated with perioperative epidural analgesia vs patient controlled analgesia.
- Compare time to ambulation, return of bowel function, and readiness for hospital discharge in patients treated with these pain management interventions.
- Compare the incidence of perioperative complications (e.g., bleeding, hypotension, thromboembolic events, pneumonia, wound infection, myocardial infection, or death) in patients treated with these pain management interventions.
OUTLINE: This is a partially randomized, double-blind, parallel-group study. Patients choose between epidural analgesia or patient controlled analgesia (PCA) for perioperative pain management. Patients for whom an epidural is contraindicated receive a PCA. Patients are assigned to 1 of 2 treatment groups. Patients in group 1 are stratified according to bowel resection surgery (yes vs no) and prior abdominal surgery (yes vs no).
Group 1 (epidural): Patients undergo placement of a thoracic epidural catheter followed by abdominal/pelvic surgery. Patients then begin an epidural infusion of ropivacaine hydrochloride and fentanyl immediately after surgery (postoperative day 0). Patients may also be supplemented with a patient controlled demand dose. The day after surgery (postoperative day 1), patients are randomized (as long as there is adequate pain control) to 1 of 2 epidural management arms.
- Arm I: Patients continue to receive the epidural infusion until they can be weaned to oral pain medication.
- Arm II: Patients undergo daily weaning of the fentanyl concentration of the epidural infusion.
- Group 2 (PCA): Patients begin PCA immediately after undergoing abdominal/pelvic surgery (postoperative day 0). Patients receive a demand schedule of hydromorphone IV until they can be weaned to oral pain medication.
In both groups, the Gynecologic Oncology pain service may make adjustments to the epidural infusion or PCA for optimal pain management until the patient can be weaned to oral pain medication.
PROJECTED ACCRUAL: A total of 224 patients will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||240 participants|
|Observational Model:||Case Control|
|Official Title:||Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||December 2009|
Patient-controlled intravenous analgesia
|Drug: hydromorphone hydrochloride|
Perioperative patient-controlled epidural analgesia
|Drug: fentanyl citrate Drug: ropivacaine hydrochloride|
- Time to return to bowel function at discharge [ Time Frame: Days ]
- Pain score daily [ Time Frame: Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295945
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Lee-may Chen, MD||University of California, San Francisco|