Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery

Completed · Phase 3

Conditions studied: Postoperative Pain

In brief

Recovery after major abdominal surgery can be longer than other types of surgery. This is because often after abdominal surgery, the bowel does not work normally. When this happens, patients are unable to pass gas. This can lead to bloating, pain, nausea and vomiting. These symptoms are called postoperative ileus. We, the researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), are doing this study to compare two methods of treating pain during and after major gynecological surgery. The two methods are called patient-controlled epidural analgesia (PCEA) and patient-controlled intravenous analgesia (PCA). PCA is the standard of care for women having major gynecological surgery. We are going to compare PCEA to PCA to see if PCEA will improve recovery after major gynecologic surgery. PCEA is a well established method used to ease pain in many settings such as during childbirth and bowel surgery. There have been several studies showing that PCEA is as good as and sometimes better for pain relief than PCA. PCEA may help the bowel work better by preventing ileus after surgery. However, this has never been looked at in women having major gynecologic surgery. This study will also look at whether preventing this ileus will lead to patients going home or returning to regular activities sooner.

Key facts

Study ID

NCT00136682

Run by

Memorial Sloan Kettering Cancer Center

People needed

240

Starts

2004-08-01

Expected to finish

2007-07-01

Last updated by the study team

2008-11-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women undergoing a laparotomy for major abdominal or pelvic surgery by the gynecology service
• Patients 18 years or older
• Patients who have signed an approved informed consent form

You may not qualify if…

• Patients undergoing total pelvic exenteration
• Patients undergoing laparoscopy only
• Patients undergoing palliative surgery for bowel obstruction
• Patients undergoing emergent operations
• Inability to take oral intake
• Current history of chronic (three months) opioid use or known active alcohol abuse
• Patients with significant cognitive impairment or documented psychologic impairment
• Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intraoperative medications will be excluded from study. These include:
• Morphine
• Bupivicaine
• Contraindication to epidural catheter placement. This includes:
• Documented preoperative coagulopathy: international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 42
• Evidence of infection at potential epidural site
• Prior extensive spinal surgery or major spinal deformity
• Platelets > 100K (bleeding diatheses, preoperative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant post-operatively)

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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