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

• ClinicalTrials.gov Identifier: NCT00295945
• Recruitment Status: Completed
• First Posted: February 24, 2006
• Last Update Posted: May 20, 2014
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment
Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Pain; Perioperative/Postoperative Complications; Sarcoma	Drug: fentanyl citrate; Drug: hydromorphone hydrochloride; Drug: ropivacaine hydrochloride

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 240 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study
• Study Start Date: March 2005
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: December 2009

Groups and Cohorts

Group/Cohort	Intervention/treatment
PCA; Patient-controlled intravenous analgesia	Drug: hydromorphone hydrochloride
PCEA; Perioperative patient-controlled epidural analgesia	Drug: fentanyl citrate; Drug: ropivacaine hydrochloride

Outcome Measures

Primary Outcome Measures :

1. Time to return to bowel function at discharge [ Time Frame: Days ]

Secondary Outcome Measures :

1. Pain score daily [ Time Frame: Days ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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)

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

Contacts and Locations

Locations

United States, California

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94115

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Study Chair: Lee-may Chen, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00295945
• Other Study ID Numbers: CDR0000459963; UCSF-03423 ( Other Identifier: UCSF CHR ); UCSF-H10588-24197-02 ( Other Identifier: UCSF CHR )
• First Posted: February 24, 2006
• Last Update Posted: May 20, 2014
• Last Verified: May 2014

Keywords provided by University of California, San Francisco:

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

Additional relevant MeSH terms:

Sarcoma; Uterine Cervical Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Postoperative Complications; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Fallopian Tube Diseases; Pathologic Processes; Fentanyl; Hydromorphone; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics; Adjuvants, Anesthesia