Pain
Conditions
Keywords
living, kidney, donors
Brief summary
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.
Detailed description
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.
Interventions
DEVICEValveless recirculating insufflation (VTI)
10 mmHg target pressure
DEVICEConventional pressure
15 mmHg target pressure
Sponsors
SurgiQuest, Inc.
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any living donor who has been approved to donate a kidney is eligible to participate.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Use (mg) | Intra-Operative on day of surgery | Total Morphine Equivalents - mean in mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Pain Score | 1 hour post-op | 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. |
| Mean ETCO2 | intraoperative | mean End-tidal carbon dioxide concentration in the expired air |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Pressure 15mmHg target pressure | 14 |
| Low Pressure (VTI) 10mmHg target pressure
VTI= Valveless recirculating insufflation | 27 |
| Total | 41 |
Baseline characteristics
| Characteristic | Low Pressure (VTI) | Total | Conventional Pressure |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 14.5 | 47.6 years STANDARD_DEVIATION 13.2 | 45.6 years STANDARD_DEVIATION 12.3 |
| ASA Class 1 | 17 participants | 26 participants | 9 participants |
| ASA Class 2 | 10 participants | 15 participants | 5 participants |
| Nephrectomy Laterality Left | 24 participants | 35 participants | 11 participants |
| Nephrectomy Laterality Right | 3 participants | 6 participants | 3 participants |
| Race/Ethnicity, Customized African American | 2 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants | 4 participants | 1 participants |
| Race/Ethnicity, Customized White | 22 participants | 33 participants | 11 participants |
| Sex: Female, Male Female | 16 Participants | 24 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 14 | 2 / 27 |
| serious Total, serious adverse events | 0 / 14 | 0 / 27 |
Outcome results
Primary
Narcotic Use (mg)
Total Morphine Equivalents - mean in mg
Time frame: Post-operative (until time of discharge, typically 2-4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Pressure | Narcotic Use (mg) | 130.8 mg | Standard Deviation 125.6 |
| Low Pressure (VTI) | Narcotic Use (mg) | 134.5 mg | Standard Deviation 80.2 |
p-value: 0.92t-test, 2 sided
Primary
Narcotic Use (mg)
Total Morphine Equivalent - mean in mg
Time frame: Operative and Post-operative (until time of discharge, typically 2-4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Pressure | Narcotic Use (mg) | 244.6 mg | Standard Deviation 126.7 |
| Low Pressure (VTI) | Narcotic Use (mg) | 234.0 mg | Standard Deviation 88 |
p-value: 0.78t-test, 2 sided
Primary
Narcotic Use (mg)
Total Morphine Equivalents - mean in mg
Time frame: Intra-Operative on day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Pressure | Narcotic Use (mg) | 113.8 mg | Standard Deviation 19 |
| Low Pressure (VTI) | Narcotic Use (mg) | 99.6 mg | Standard Deviation 25 |
p-value: <0.05t-test, 2 sided
Secondary
Mean ETCO2
mean End-tidal carbon dioxide concentration in the expired air
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Pressure | Mean ETCO2 | 29.7 mmHg | Standard Deviation 4.4 |
| Low Pressure (VTI) | Mean ETCO2 | 30.8 mmHg | Standard Deviation 3 |
p-value: 0.45t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Pressure | Subjective Pain Score | 4.6 units on a scale | Standard Deviation 3.2 |
| Low Pressure (VTI) | Subjective Pain Score | 5.3 units on a scale | Standard Deviation 3.2 |
p-value: 0.52t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Pressure | Subjective Pain Score | 3.5 units on a scale | Standard Deviation 3.2 |
| Low Pressure (VTI) | Subjective Pain Score | 4.6 units on a scale | Standard Deviation 2.6 |
p-value: 0.25t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Pressure | Subjective Pain Score | 3.9 units on a scale | Standard Deviation 3 |
| Low Pressure (VTI) | Subjective Pain Score | 3.7 units on a scale | Standard Deviation 2.7 |
p-value: 0.82t-test, 2 sided