Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Pain; Perioperative/Postoperative Complications; Sarcoma
Intervention: fentanyl citrate (Drug); hydromorphone hydrochloride (Drug); ropivacaine hydrochloride (Drug)
Sponsored by: University of California, San Francisco
Official(s) and/or principal investigator(s):
Lee-may Chen, MD, Study Chair, Affiliation: University of California, San Francisco
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
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.
Official title: Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study
Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Primary outcome: Time to return to bowel function at discharge
Secondary outcome: Pain score daily
- 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
- 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
PROJECTED ACCRUAL: A total of 224 patients will be accrued for this study.
Minimum age: N/A.
Maximum age: N/A.
- Diagnosis of a gynecologic malignancy
- Scheduled to undergo open abdominal/pelvic surgery (i. e., laparotomy) on the
gynecologic oncology service at the University of California San Francisco Medical
- No failed epidural catheters (for patients choosing epidural analgesia)
- No lumbar epidurals (for patients choosing epidural analgesia)
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Locations and Contacts
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States; Recruiting
Clinical Trials Office - UCSF Helen Diller Family Comprehensi, Phone: 877-827-3222
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2005
Last updated: July 13, 2011