Status:
COMPLETED
Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 unabl...
Detailed Description
The objective of this study is pain at rest and coughing in addition to determine the effect of intraoperative and postoperative thoracic patient-controlled epidural analgesia (PCEA) compared to posto...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00136682
Start Date
August 1 2004
End Date
July 1 2007
Last Update
November 10 2008
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021