Primary Outcome Measures:
- Aim #1: To determine whether LVPGA reduces blood loss by >= 300 ml versus CSE in patients undergoing open RRP
- Aim #2: To compare transfusion rates of autologous and allogenic blood between the two anesthesia groups
- Aim #3: To identify differences in pattern of blood loss in the two groups according to different surgical stages
- Stage I: Pelvic Lymph node dissection: From skin incision to completion of pelvic node dissection
- Stage II: Prostatectomy: From endopelvic fascia opening to completion of prostatic bed hemostasis after the prostate is removed
- Stage II a: Dorsal venous complex control: From endopelvic fascia opening to beginning of nerve bundles dissection (or ligature in case they were not preserved)
- Stage II b: Nerve bundles dissection and prostate removal: From the beginning of nerve bundles dissection to completion of prostatic bed hemostasis after the prostate is removed
- Stage III: Urinary tract reconstruction: From bladder neck reconstruction to completion of skin closure
Secondary Outcome Measures:
- To compare postoperative complication type, incidence and grade experienced by the two groups. The current MSKCC morbidity and mortality definitions and grading system will be utilized
- To compare the efficacy of pain control postoperatively in the two groups (epidural PCA versus intravenous PCA+ NSAID’s)
- To compare length of hospital stay for the two groups
- To prospectively evaluate the relationship of pelvimetry, urethral length and prostatic veins size on MRI 1 to intraoperative blood loss and complications
This is a prospective randomized trial comparing the efficacy of a low venous pressure general anesthesia (LVPGA) technique vs. combined spinal-epidural anesthesia (CSE) in decreasing intraoperative blood loss in patients undergoing open radical retropubic prostatectomy (RRP) for newly diagnosed clinically localized adenocarcinoma of the prostate. The study design involves the enrollment of 246 patients scheduled for RRP. To control for surgeon technique in the varibility of intraoperative blood loss, the study will be limited to the patient population of two surgeons who perform greater than 150 radical prostatectomies per year. Patients will be stratified for each surgeon and will be randomized to receive either a LVPGA or CSE. Preoperatively patients will be encouraged to donate autologous blood as is the current practice at MSKCC. Perioperative measurement and management of fluid administration, estimation of blood loss and urine output, and transfusion criteria will be standardized for both anesthesia groups. Transfusion of blood products will be at the discretion of the attending surgeon and anesthesiologist following the guidelines described in the protocol. Autologous blood will not routinely be transfused back if the hemoglobin is >= 8.0 and the patient is not symptomatic. Patients randomized to the CSE arm will also receive postoperative epidural analgesia, while patients randomized to LVPGA will receive intravenous PCA analgesia as per our current standard of care. Pain relief will be assessed by a standardized pain scale and recorded in the PACU and then twice daily until discharge. All patients will receive routine preoperative evaluation, as well as routine intraoperative and postoperative monitoring and care. All patients will be placed on a routine postoperative pathway. The MSKCC Morbidity/Mortality DMT Documentation System will be utilized to document postoperative complications as per our routine practice. The Surgical Secondary Events (SSE) program is designed to provide risk adjusted postoperative morbidity and mortality data for institutional comparisons and as a decision support project, generating, reporting and analyzing events to promote change and improvement in patient management. SSE are grouped in 6 grades depending on the severity of the complication and the treatment requirements: Grade 0, no event observed beyond 30 days postop. Grade 1, use of oral medications, bedside interventions to treat an event. Grade 2, use of I.V. medications, TPN, enteral nutrition, or blood transfusion to treat an event. Grade 3, interventional radiology, therapeutic endoscopy, intubation, angiography or operation required to treat an event. Grade 4, residual and lasting disability requiring major rehabilitation or organ resection. Grade 5, event resulting in death of patient.