Clinical trial NCT00295945: Epidural Analgesia or 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Pain
Perioperative/Postoperative Complications
Sarcoma
Keywords: pain
perioperative/postoperative complications
stage III cervical cancer
recurrent cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IVB cervical cancer
stage IA cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
ovarian sarcoma
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
ovarian stromal cancer
recurrent fallopian tube cancer
stage IA fallopian tube cancer
stage IB fallopian tube cancer
stage IC fallopian tube cancer
stage IIA fallopian tube cancer
stage IIB fallopian tube cancer
stage IIC fallopian tube cancer
stage IIIA fallopian tube cancer
stage IIIB fallopian tube cancer
stage IIIC fallopian tube cancer
stage IV fallopian tube cancer
stage IA ovarian epithelial cancer
stage IB ovarian epithelial cancer
stage IC ovarian epithelial cancer
stage IIA ovarian epithelial cancer
stage IIB ovarian epithelial cancer
stage IIC ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer
stage IA ovarian germ cell tumor
stage IB ovarian germ cell tumor
stage IC ovarian germ cell tumor
stage IIA ovarian germ cell tumor
stage IIB ovarian germ cell tumor
stage IIC ovarian germ cell tumor
stage IIIA ovarian germ cell tumor
stage IIIB ovarian germ cell tumor
stage IIIC ovarian germ cell tumor
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2006-02-24
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Time to return to bowel function at discharge
timeFrame: Days
Secondary outcomes:
measure: Pain score daily
timeFrame: Days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lee-may Chen, MD
role: STUDY_CHAIR
References: