The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.
Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety. The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
41
10 mmHg target pressure
15 mmHg target pressure
Yale New Haven Transplantation Center
New Haven, Connecticut, United States
Narcotic Use (mg)
Total Morphine Equivalents - mean in mg
Time frame: Intra-Operative on day of surgery
Narcotic Use (mg)
Total Morphine Equivalents - mean in mg
Time frame: Post-operative (until time of discharge, typically 2-4 days)
Narcotic Use (mg)
Total Morphine Equivalent - mean in mg
Time frame: Operative and Post-operative (until time of discharge, typically 2-4 days)
Subjective Pain Score
Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
Time frame: 1 hour post-op
Subjective Pain Score
Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.
Time frame: 6 hours post-op
Subjective Pain Score
Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
Time frame: 12 hours post-op
Mean ETCO2
mean End-tidal carbon dioxide concentration in the expired air
Time frame: intraoperative
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