Using an artificial intelligence-based device to investigate pain outcomes in robotic prostatectomy at low pressure pneumoperitoneum: The RALP clinical trial

Objective This study aims to investigate any differences in the levels of intra-operative (measured by an artificial intelligence device) and post-operative pain between two different abdominal insufflators (AirSeal vs Stryker) used for a low-pressure pneumoperitoneum robotic prostatectomy. Methods A prospective randomised controlled clinical study was performed at Lister Hospital, Stevenage. The primary aim was to evaluate the feasibility of recruiting 40 patients with localised prostate cancer who underwent a robotic prostatectomy with either an AirSeal® Insufflation System (n = 20) or Stryker PneumoClear Insufflator (n = 20) for the management of low-pressure pneumoperitoneum (8 mmHg). The co-primary aim was to investigate any differences in intra-operative significant nociceptive stimulus (NOL ≥ 25 for ≥1 min) measured by the Medasense PMD-200 device, in addition to post-operative pain scoring and opioid consumption. The secondary aim of the study was to assess any differences in surgical factors (blood loss, console and total procedure time, length of stay, readmission rates, adverse events, differences in creatinine and haemoglobin and unplanned pneumo-peritoneal pressure changes). Results Forty patients were successfully recruited onto the RALP trial with complete 30-day follow-up. AirSeal has fewer significant nociceptive events per recorded hour than Stryker (20.7 vs. 33.5, p = 0.041). Shorter procedure times (p = 0.045), console times (p = 0.045) and blood loss (p < 0.001) were seen in the AirSeal arm of the trial. There were no statistical differences in post-operative pain scores, analgesia consumption at POD1 (p = 0.599) and at discharge (p = 0.488). There were four (n = 4) adverse effects reported with the Stryker arm of the trial (n = 3 ileus, n = 1 UTI) leading to two (n = 2) formal re-admissions. Conclusions and relevance In this study, we were able to successfully recruit 40 participants with complete 30-day follow-up. There were advantageous surgical factors and lesser intra-operative nociceptive insult associated with the AirSeal insufflator. Further RCTs are planned with a larger population to investigate the true causality of this relationship.