Regional Anesthesia and Endometrial Cancer Recurrence

Withdrawn before enrolling · Phase 3

Conditions studied: Cancer

In brief

The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia.

Key facts

Study ID

NCT00531349

Run by

The Cleveland Clinic

People needed

0

Starts

2007-11-01

Expected to finish

2007-11-01

Last updated by the study team

2016-05-09

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Primary endometrial cancer without known extension beyond the uterus i.e., believed to be Stage 1 or 2
• Scheduled for open abdominal hysterectomy
• Written informed consent, including willingness to be randomized epidural anesthesia/analgesia with sedation or to sevoflurane general anesthesia and postoperative opioid analgesia

You may not qualify if…

• Previous surgery for endometrial cancer
• Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy)
• Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
• Age < 18 or > 85 years old
• ASA Physical Status ≥ 4
• Any contraindication to epidural anesthesia and analgesia (including coagulopathy, abnormal anatomy)
• Other cancer not believed by the attending surgeon to be in long-term remission
• Systemic disease believed by the attending surgeon or anesthesiologist to present ≥ 25% two-year mortality

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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