Ultralow Versus Standard Pneumoperitoneum Pressure

Not Applicable

Terminated

Interventions: Other: Pneumoperitoneum Pressure 6 mmHg
Other: Pneumoperitoneum Pressure 15 mmHg

Brief Summary: The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.

Detailed Description: The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Age < 18
Emergency surgery
Patients with a significant preoperative dependence on narcotic medications
Unable to give informed consent
Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results)
Non-English-speaking or reading

Arm && Interventions

Group	Intervention	Description
Pressure 6 mmHg	Pneumoperitoneum Pressure 6 mmHg	Pneumoperitoneum Pressure 6 mmHg
Pressure 15 mmHg	Pneumoperitoneum Pressure 15 mmHg	Pneumoperitoneum Pressure 15 mmHg

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Medication Use	Through 1 week postoperatively	The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.

Secondary Outcome Measures

Name	Time	Method
Post Operative Pain Scores	Through discharge (post-operative day 0 or post-operative day 1)	Each participant was asked to rate their pain on a 0-10 scale, with higher numbers representing worse pain. Patients rated their pain at the following time points: in the post-anesthesia care unit (PACU) upon waking from anesthesia, at hours 4, 12, 16, and 20 after transfer to the floor, and immediately prior to discharge. The pain scores for each patient were averaged.
Operative Ventilation	Intraoperatively	Average tidal volume (ml)
Discharge Day (Post-operative Day 0 or 1)	Through discharge (post-operative day 0 or 1)	The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant