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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00295945
First received: February 23, 2006
Last updated: May 19, 2014
Last verified: May 2014

February 23, 2006
May 19, 2014
March 2005
April 2008   (final data collection date for primary outcome measure)
Time to return to bowel function at discharge [ Time Frame: Days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00295945 on ClinicalTrials.gov Archive Site
Pain score daily [ Time Frame: Days ] [ Designated as safety issue: No ]
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Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer
Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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)
  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Pain
  • Perioperative/Postoperative Complications
  • Sarcoma
  • Drug: fentanyl citrate
  • Drug: hydromorphone hydrochloride
  • Drug: ropivacaine hydrochloride
  • PCA
    Patient-controlled intravenous analgesia
    Intervention: Drug: hydromorphone hydrochloride
  • PCEA
    Perioperative patient-controlled epidural analgesia
    Interventions:
    • Drug: fentanyl citrate
    • Drug: ropivacaine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
December 2009
April 2008   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00295945
CDR0000459963, UCSF-03423, UCSF-H10588-24197-02
Not Provided
University of California, San Francisco
University of California, San Francisco
Not Provided
Study Chair: Lee-may Chen, MD University of California, San Francisco
University of California, San Francisco
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP