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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pain at rest and when coughing - assessed by visual analog scale (VAS)
conclusion of the study
Nadeem R. Abu-Rustum, M.D.
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|