Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Time to return to bowel function at discharge
Lee-may Chen, MD
University of California, San Francisco
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|