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


N/A
N/A
N/A
Open (Enrolling)
Female
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Pain, Perioperative/Postoperative Complications, Sarcoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Time to return to bowel function at discharge

Principal Investigator

Lee-may Chen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

Unspecified

Study ID:

CDR0000459963

NCT ID:

NCT00295945

Start Date:

March 2005

Completion Date:

Related Keywords:

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

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115