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

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295945


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
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00295945     History of Changes
Other Study ID Numbers: CDR0000459963
UCSF-03423 ( Other Identifier: UCSF CHR )
UCSF-H10588-24197-02 ( Other Identifier: UCSF CHR )
First Posted: February 24, 2006    Key Record Dates
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
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
 Fallopian Tube Diseases
Adnexal Diseases
Pathologic Processes
Fentanyl
Hydromorphone
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous