Nephrectomy
Conditions
Brief summary
The aim of this study is to determine whether intravenous acetaminophen compared to enteric acetaminophen offers increased efficacy in patients who are scheduled for laparoscopic donor nephrectomy and for patients scheduled for robot-assisted, laparoscopic nephrectomy for cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.
Interventions
DRUGacetaminophen
Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag.
DRUGAcetaminophen
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
DRUGPlacebos
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
DRUGPlacebo Oral Tablet
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years old * Be scheduled for donor nephrectomy or robot-assisted, laparoscopic nephrectomy for cancer at University of Rochester Medical Center * Have cognitive ability to verbally rate their pain on the Numeric Rating Scale (NRS).
Exclusion criteria
* Age younger than 18 years old or older than 90 years old * Pregnancy (Pre-operative pregnancy test is standard of care for all elective operating room cases) * Weight less than 50 kg * Epidural use * History of known liver disease. * Patient unable to take enteral medications. * Be taking opioid medications chronically.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Dose (MME) Used in 24 Hours | 20 to 24 hours post-operatively | Total opiate dose used from the study start (when the first dose of acetaminophen is administered in the pre-anesthesia holding area) to 24 hours post-operatively (in morphine milligram equivalents (MME)).This will include opiates administered intra-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Inspiratory Capacity | 1-2 hours post-operatively | The mean inspiratory capacity is presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity, recorded at the time of pain intensity assessments between 1-2 hours postoperatively. Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical) and recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Higher percentages reflect better recovery of inspiratory function. |
| Dynamic Pain Score During Incentive Spirometer Use | 1-2 hours post-operatively | Dynamic pain score on a 0-10 numeric rating scale (NRS) with incentive spirometer use taken during pain intensity assessments at 1-2 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain. |
| Surgical Pain Score During the 20-24 Hour Assessment | 20-24 hours post-operatively | Pain intensity on a 0-10 numeric rating scale (NRS) prior to incentive spirometry use was taken during pain intensity assessments at 20-24 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain. |
| Average Surgical Pain Intensity | 20-24 hours post-operatively | Average surgical pain intensity on a 0-10 numeric rating scale (NRS) administered between 20 and 24 hours post-operatively, with gatekeeping used to control for multiplicity. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain. |
| Number of Participants With Nausea | 24 hours post-operatively | Number of participants with nausea was assessed based on the administration of anti-emetic medications, with a value of 0 indicating no nausea and 1 indicating the presence of nausea. |
| Time to Discharge From Post-anesthesia Care Unit | 24 hours | Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge. |
| Time to Hospital Discharge | 30 days | Number of days to discharge from hospital |
| Time to First Narcotic Use | 24 hours post-operatively | Time to first postoperative narcotic use, measured in hours (range: 1 to 24). |
Countries
United States
Participant flow
Recruitment details
Adult patients 18 years to 90 years old with the cognitive ability to rate their pain on the Numeric Rating Scale (NRS) and who were scheduled for laparoscopic donor nephrectomy, robot-assisted laparoscopic donor nephrectomy, or robot-assisted laparoscopic nephrectomy for renal cancer at the University of Rochester Medical Center (URMC) were eligible for enrollment.
Pre-assignment details
There were 57 subjects who were withdrawn, however 6 of those subjects were included in the intent to treat analysis. as they did receive one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| IV Acetaminophen and Placebo Pills acetaminophen: Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag.
Placebo Oral Tablet: Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours | 108 |
| Placebo IV (Normal Saline) + Oral Acetaminophen Acetaminophen: 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
Placebos: Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag. | 106 |
| Total | 214 |
Baseline characteristics
| Characteristic | IV Acetaminophen and Placebo Pills | Placebo IV (Normal Saline) + Oral Acetaminophen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 30 Participants | 58 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 76 Participants | 156 Participants |
| Age, Continuous | 54.0 Age in years STANDARD_DEVIATION 14.6 | 54.4 Age in years STANDARD_DEVIATION 15.1 | 54.2 Age in years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 95 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 9 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) White | 94 Participants | 100 Participants | 194 Participants |
| Region of Enrollment United States | 108 Participants | 106 Participants | 214 Participants |
| Sex: Female, Male Female | 51 Participants | 58 Participants | 109 Participants |
| Sex: Female, Male Male | 57 Participants | 48 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 106 |
| other Total, other adverse events | 14 / 108 | 16 / 106 |
| serious Total, serious adverse events | 1 / 108 | 1 / 106 |
Outcome results
Primary
Total Opioid Dose (MME) Used in 24 Hours
Total opiate dose used from the study start (when the first dose of acetaminophen is administered in the pre-anesthesia holding area) to 24 hours post-operatively (in morphine milligram equivalents (MME)).This will include opiates administered intra-operatively.
Time frame: 20 to 24 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Total Opioid Dose (MME) Used in 24 Hours | 103.61 total morphine milligram equivalents | Standard Deviation 58.16 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Total Opioid Dose (MME) Used in 24 Hours | 109.17 total morphine milligram equivalents | Standard Deviation 57.59 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the total opioid dose administered intraoperatively and postoperatively, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.393895% CI: [-8.242, 20.854]Regression, Linear
Secondary
Average Surgical Pain Intensity
Average surgical pain intensity on a 0-10 numeric rating scale (NRS) administered between 20 and 24 hours post-operatively, with gatekeeping used to control for multiplicity. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain.
Time frame: 20-24 hours post-operatively
Population: A total of 6 participants were missing: 4 from the IV acetaminophen group and 2 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Average Surgical Pain Intensity | 4.87 score on a scale | Standard Deviation 2.2 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Average Surgical Pain Intensity | 5.00 score on a scale | Standard Deviation 1.96 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.705195% CI: [-0.451, 0.666]Regression, Linear
Secondary
Average Surgical Pain Intensity
Average surgical pain intensity on a 0-10 numeric rating scale (NRS) administered between 20 and 24 hours post-operatively, with gatekeeping used to control for multiplicity. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain.
Time frame: 1-2 hours post-operatively
Population: A total of 5 participants were missing: 3 from the IV acetaminophen group and 2 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Average Surgical Pain Intensity | 4.46 score on a scale | Standard Deviation 2.34 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Average Surgical Pain Intensity | 4.77 score on a scale | Standard Deviation 2.41 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.385295% CI: [-0.349, 0.901]Regression, Linear
Secondary
Dynamic Pain Score During Incentive Spirometer Use
Dynamic pain score on a 0-10 numeric rating scale (NRS) with incentive spirometer use taken during pain intensity assessments at 20-24 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain.
Time frame: 20-24 hours post-operatively
Population: A total of 9 participants were missing: 5 from the IV acetaminophen group and 4 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Dynamic Pain Score During Incentive Spirometer Use | 4.62 score on a scale | Standard Deviation 2.56 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Dynamic Pain Score During Incentive Spirometer Use | 5.12 score on a scale | Standard Deviation 2.25 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.150295% CI: [-0.177, 1.145]Regression, Linear
Secondary
Dynamic Pain Score During Incentive Spirometer Use
Dynamic pain score on a 0-10 numeric rating scale (NRS) with incentive spirometer use taken during pain intensity assessments at 1-2 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain.
Time frame: 1-2 hours post-operatively
Population: A total of 6 participants were missing: 3 from the IV acetaminophen group and 3 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Dynamic Pain Score During Incentive Spirometer Use | 4.73 score on a scale | Standard Deviation 2.71 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Dynamic Pain Score During Incentive Spirometer Use | 5.15 score on a scale | Standard Deviation 2.51 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.247995% CI: [-0.28, 1.078]Regression, Linear
Secondary
Mean Inspiratory Capacity
The mean inspiratory capacity is presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity, recorded at the time of pain intensity assessments between 1-2 hours postoperatively. Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical) and recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Higher percentages reflect better recovery of inspiratory function.
Time frame: 1-2 hours post-operatively
Population: A total of 6 participants were missing: 3 from the IV acetaminophen group and 3 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Mean Inspiratory Capacity | 66.60 percent of baseline inspiratory capacity | Standard Deviation 20.26 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Mean Inspiratory Capacity | 67.07 percent of baseline inspiratory capacity | Standard Deviation 20.74 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.849895% CI: [-5.02, 6.088]Regression, Linear
Secondary
Mean Inspiratory Capacity
The mean inspiratory capacity is presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity, recorded at the time of pain intensity assessments between 20-24 hours postoperatively. Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical) and recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Higher percentages reflect better recovery of inspiratory function.
Time frame: 20-24 hours post-operatively
Population: A total of 7 participants were missing: 4 from the IV acetaminophen group and 3 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Mean Inspiratory Capacity | 64.41 percent of baseline inspiratory capacity | Standard Deviation 21.82 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Mean Inspiratory Capacity | 63.35 percent of baseline inspiratory capacity | Standard Deviation 22.57 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.583995% CI: [-7.579, 4.28]Regression, Linear
Secondary
Number of Participants With Nausea
Number of participants with nausea was assessed based on the administration of anti-emetic medications, with a value of 0 indicating no nausea and 1 indicating the presence of nausea.
Time frame: 24 hours post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen and Placebo Pills | Number of Participants With Nausea | 58 Participants |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Number of Participants With Nausea | 40 Participants |
Comparison: A logistic regression model was used to examine the association between treatment assignment and incidence of nausea, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.049995% CI: [0.217, 1]Regression, Logistic
Secondary
Surgical Pain Score During the 20-24 Hour Assessment
Pain intensity on a 0-10 numeric rating scale (NRS) prior to incentive spirometry use was taken during pain intensity assessments at 20-24 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing no pain and 10 representing the worst possible pain.
Time frame: 20-24 hours post-operatively
Population: A total of 16 participants were missing: 10 from the IV acetaminophen group and 6 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Surgical Pain Score During the 20-24 Hour Assessment | 3.52 score on a scale | Standard Deviation 2.25 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Surgical Pain Score During the 20-24 Hour Assessment | 3.89 score on a scale | Standard Deviation 2.14 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op surgical pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.279795% CI: [-0.278, 0.955]Regression, Linear
Secondary
Time to Discharge From Post-anesthesia Care Unit
Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Time to Discharge From Post-anesthesia Care Unit | 174.17 Minutes | Standard Deviation 82.99 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Time to Discharge From Post-anesthesia Care Unit | 195.48 Minutes | Standard Deviation 170.41 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and time to discharge from PACU, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.17995% CI: [-11.321, 60.304]Regression, Linear
Secondary
Time to First Narcotic Use
Time to first postoperative narcotic use, measured in hours (range: 1 to 24).
Time frame: 24 hours post-operatively
Population: A total of 24 participants were missing: 14 from the IV acetaminophen group and 10 from the oral acetaminophen group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Time to First Narcotic Use | 3.31 hours | Standard Deviation 5.34 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Time to First Narcotic Use | 2.85 hours | Standard Deviation 4.91 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and time to first narcotic use, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.652795% CI: [-1.792, 1.125]Regression, Linear
Secondary
Time to Hospital Discharge
Number of days to discharge from hospital
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen and Placebo Pills | Time to Hospital Discharge | 2.33 Days | Standard Deviation 1.3 |
| Placebo IV (Normal Saline) + Oral Acetaminophen | Time to Hospital Discharge | 2.60 Days | Standard Deviation 2.27 |
Comparison: A multiple linear regression model was used to examine the association between treatment assignment and time to hospital discharge, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.p-value: 0.281195% CI: [-0.226, 0.773]Regression, Linear