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

Pain Clinical Trial

Official title:

Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295945
• Other study ID #: CDR0000459963
• Secondary ID: UCSF-03423UCSF-H
• Status: Completed
• Phase: N/A
• First received: February 23, 2006
• Last updated: May 19, 2014
• Start date: March 2005
• Est. completion date: December 2009

Study information

• Verified date: May 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Pain
• Perioperative/Postoperative Complications
• Postoperative Complications
• Sarcoma
• Uterine Cervical Neoplasms

Intervention

Drug:
• fentanyl citrate

• hydromorphone hydrochloride

• ropivacaine hydrochloride

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to return to bowel function at discharge		Days	No
Secondary	Pain score daily		Days	No