Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer

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)

Phase: N/A

Status: Recruiting

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 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.

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

Detailed description: OBJECTIVES:

- 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

DISEASE CHARACTERISTICS:

- 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 Center

- No failed epidural catheters (for patients choosing epidural analgesia)

- No lumbar epidurals (for patients choosing epidural analgesia)

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

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