Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136682
Status:
COMPLETED
Last Update Posted:
2008-11-10
First Post:
2005-08-25
Brief Title:
Patient-Controlled Epidural Analgesia PCEA for Patients Who Have Had Major Open Gynecologic Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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 this study with an accrual rate of 5 to 10 patients per month This study will be a randomized controlled clinical trial Subjects will be randomized to either general anesthesia with postoperative intravenous patient controlled analgesia control group or general anesthesia with intraoperative thoracic epidural anesthesia and postoperative thoracic patient-controlled epidural analgesia treatment group This study will not be blinded because of the ethical issues with placing a sham epidural catheter in half of the study participants These patients will be followed prospectively and relevant postoperative parameters will be measured in both groups and compared This study will address the potential benefits of epidural analgesia on multiple measurements of postoperative recovery This study will address the potential benefits of epidural analgesia on multiple measurements of postoperative recovery The primary outcome of interest in this study is pain at rest and when coughing The secondary outcome is the time to potential discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None