Study Comparing Two Surgical Devices for Pain During Robotic Prostatectomy in Men Aged 18 to 75

What this Trial Is About

The trial investigates pain outcomes associated with robotic prostatectomy surgery used to treat prostate cancer in adult male patients. It aims to compare pain levels when using two different devices that inflate the abdomen during surgery, assessing their impact on intra-operative and post-operative pain. This feasibility study will help design a larger trial by gathering data on recruitment, study procedures, and safety of these devices. In this trial, 100 male patients aged 18 to 75 undergoing robotic prostatectomy will be randomly assigned to have abdominal inflation maintained by either the AIRSEAL4 Insufflation System or the Stryker PneumoClear Insufflator, both set at 8 mmHg pressure. The surgery is performed by one surgeon following standard procedures. Data on pain, medication use, procedure duration, recovery time, hospital stay, nausea, vomiting, and adverse events will be collected for 30 days after surgery. Participants provide informed consent and undergo pre-operative assessments including medical history and labs. Pain severity will be measured by numeric rating scales and a nociception monitor during and after surgery. Follow-up occurs 30 days post-operation to evaluate pain, medication use, complications, and hospital readmissions. All data will be anonymized, analyzed, and may inform future multi-center trials.

Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial