Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery
Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Aug 26, 2005
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
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 postoperative intravenous patient-controlled analgesia (PCA) on postoperative recovery parameters, such as time to potential discharge and resumption of intestinal function after major open gynecologic surgery. The population included in this study will be women undergoing a laparotomy for major abdominal or pelvic surgery by the gynecology service. There will be a total of 240 women recruited for t...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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)
About Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Nadeem R. Abu-Rustum, M.D.
Principal Investigator
Memorial Sloan Kettering Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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