- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136682
Patient-Controlled Epidural Analgesia (PCEA) for Patients Who Have Had Major Open Gynecologic Surgery
Postoperative Recovery in Patients Receiving Patient-Controlled Epidural Analgesia (PCEA) Compared to Patient-Controlled Intravenous Analgesia (PCA) After Major Open Gynecologic Surgery: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: (PCEA)
patient-controlled epidural analgesia PCEA involves having an epidural catheter placed before surgery.The epidural catheter will be used during surgery to give drugs, such as morphine and a local anesthetic bupivacaine, which will help control pain.
After surgery, a constant flow of pain-reducing medicine, such as morphine, will be given through the catheter.
This is controlled by the patient.
|
During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness.
While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food.
This will be done once a day by a research assistant or by the research investigators.
|
Active Comparator: PCA
patient-controlled intravenous analgesia (PCA) PCA involves placing a tube into the patient's vein after surgery.
The tube is connected to a pump that is controlled by the patient.
The pump holds a medicine, such as morphine, that eases pain.
|
During the consent process you will be given a patient data sheet to assess your baseline pain and itchiness.
While in the hospital you will be given a patient data sheet to fill out information regarding pain, nausea, when you passed gas, and when you ate food.
This will be done once a day by a research assistant or by the research investigators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain at rest and when coughing - assessed by visual analog scale (VAS)
Time Frame: conclusion of the study
|
conclusion of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time (in days) to potential discharge based on documentation of all of the discharge criteria below: Toleration of diet (as assessed by tolerating clear fluid diet for 24 hours without nausea requiring antiemetic or vomiting within 4 hours of a meal)
Time Frame: conclusion of the study
|
conclusion of the study
|
Passing of flatus (as assessed by patient)
Time Frame: conclusion of the study
|
conclusion of the study
|
Absence of fever for 24 hours
Time Frame: conclusion of the study
|
conclusion of the study
|
Actual length of stay in hospital (in days). This may be different from actual time of potential discharge as met by criteria in primary outcome
Time Frame: conclusion of the study
|
conclusion of the study
|
Nausea (yes/no)
Time Frame: conclusion of the study
|
conclusion of the study
|
Vomiting (number episodes per day)
Time Frame: conclusion of the study
|
conclusion of the study
|
Use of anti-emetics per day (yes/no)
Time Frame: conclusion of the study
|
conclusion of the study
|
Pruritus per day (yes/no)
Time Frame: conclusion of the study
|
conclusion of the study
|
Overall patient satisfaction - questionnaire
Time Frame: conclusion of the study
|
conclusion of the study
|
Postoperative complications - complications occurring within 30 days of surgery as assessed by MSKCC surgical secondary events grading system
Time Frame: conclusion of the study
|
conclusion of the study
|
Complications related to intraoperative events (anesthetic and surgical)
Time Frame: conclusion of the study
|
conclusion of the study
|
Complications arising from analgesic techniques
Time Frame: conclusion of the study
|
conclusion of the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nadeem R. Abu-Rustum, M.D., Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-091
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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