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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV acetaminophen and placebo pills | Active Comparator |
| |
| placebo IV (normal saline) + oral acetaminophen | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetaminophen | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 to 24 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 20-24 hours post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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There were 57 subjects who were withdrawn, however 6 of those subjects were included in the intent to treat analysis.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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | total morphine milligram equivalents | 20 to 24 hours post-operatively |
|
Up to 24 hours post-operatively or until hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemias non-hemolytic and marrow depression | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
The main limitation was the addition of TAP blocks mid-study for laparoscopic nephrectomy patients. This change likely didn't affect results, as both groups had similar exposure. Variability in gastric drainage, delayed PACU dosing due to lethargy, and prolonged procedures may have influenced outcomes. Lastly, no control group without acetaminophen was included due to ethical concerns over withholding standard pain management.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Dooley, MD | University of Rochester Medical Center | 5852752141 | joseph_dooley@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2023 | Apr 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2023 | Apr 10, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Acetaminophen | Drug | 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours |
|
| Placebos | Drug | Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag. |
|
| Placebo Oral Tablet | Drug | Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours |
|
| 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". | 1-2 hours post-operatively |
| 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. | 1-2 hours post-operatively |
| 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. | 20-24 hours post-operatively |
| 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". | 1-2 hours post-operatively |
| 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". | 20-24 hours post-operatively |
| 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". | 20-24 hours post-operatively |
| Time to First Narcotic Use | Time to first postoperative narcotic use, measured in hours (range: 1 to 24). | 24 hours post-operatively |
| 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. | 24 hours post-operatively |
| Time to Discharge From Post-anesthesia Care Unit | Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge. | 24 hours |
| Time to Hospital Discharge | Number of days to discharge from hospital | 30 days |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | Age in years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
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. |
|
|
|
| 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". | A total of 6 participants were missing: 4 from the "IV acetaminophen" group and 2 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | score on a scale | 20-24 hours post-operatively |
|
|
|
|
| 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". | A total of 5 participants were missing: 3 from the "IV acetaminophen" group and 2 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | score on a scale | 1-2 hours post-operatively |
|
|
|
|
| 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. | A total of 6 participants were missing: 3 from the "IV acetaminophen" group and 3 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | percent of baseline inspiratory capacity | 1-2 hours post-operatively |
|
|
|
|
| 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. | A total of 7 participants were missing: 4 from the "IV acetaminophen" group and 3 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | percent of baseline inspiratory capacity | 20-24 hours post-operatively |
|
|
|
|
| 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". | A total of 6 participants were missing: 3 from the "IV acetaminophen" group and 3 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | score on a scale | 1-2 hours post-operatively |
|
|
|
|
| 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". | A total of 9 participants were missing: 5 from the "IV acetaminophen" group and 4 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | score on a scale | 20-24 hours post-operatively |
|
|
|
|
| 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". | A total of 16 participants were missing: 10 from the "IV acetaminophen" group and 6 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | score on a scale | 20-24 hours post-operatively |
|
|
|
|
| Secondary | Time to First Narcotic Use | Time to first postoperative narcotic use, measured in hours (range: 1 to 24). | A total of 24 participants were missing: 14 from the "IV acetaminophen" group and 10 from the "oral acetaminophen" group. | Posted | Mean | Standard Deviation | hours | 24 hours post-operatively |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 24 hours post-operatively |
|
|
|
|
| Secondary | Time to Discharge From Post-anesthesia Care Unit | Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge. | Posted | Mean | Standard Deviation | Minutes | 24 hours |
|
|
|
|
| Secondary | Time to Hospital Discharge | Number of days to discharge from hospital | Posted | Mean | Standard Deviation | Days | 30 days |
|
|
|
|
| 0 |
| 108 |
| 1 |
| 108 |
| 14 |
| 108 |
| EG001 | 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. | 0 | 106 | 1 | 106 | 16 | 106 |
| Cognitive and attention disorders | Nervous system disorders | Systematic Assessment |
|
| Urinary tract infections and Epididymal and testicular infections | Infections and infestations | Systematic Assessment |
|
| Anemias non-hemolytic and marrow depression | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Corneal disorders | Eye disorders | Non-systematic Assessment |
|
| Respiratory failures and dysfunctions | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Muscle disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Intraoperative and post-op hemorrhages | Vascular disorders | Non-systematic Assessment |
|
| Cardiac arrhythmias | Cardiac disorders | Non-systematic Assessment |
|
| Liver function analyses | Hepatobiliary disorders | Non-systematic Assessment |
|
| Air leak syndromes | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Body temperature conditions | General disorders | Non-systematic Assessment |
|
| Renal function analyses | Renal and urinary disorders | Non-systematic Assessment |
|
| Infusion site reactions | General disorders | Non-systematic Assessment |
|
| Vascular hypotensive disorders | Vascular disorders | Non-systematic Assessment |
|
| Hypotension post-op | Vascular disorders | Non-systematic Assessment |
|
| Systemic and deep-seated mycoses | Infections and infestations | Non-systematic Assessment |
|
| Post-op disorder of lymphatic vessels | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Renal function analyses & White blook cell abnormal | Renal and urinary disorders | Non-systematic Assessment |
|
| Skin ulcerations and conditions necrotic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Peripheral neuropathies | Nervous system disorders | Non-systematic Assessment |
|
| Respiratory failure post-op | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Postoperative ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute and chronic renal failures | Renal and urinary disorders | Non-systematic Assessment |
|
| Abnormal kidney function analyses | Renal and urinary disorders | Non-systematic Assessment |
|
| Electrolyte and fluid balance conditions | Metabolism and nutrition disorders | Non-systematic Assessment |
|
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| Aniline Compounds |
| D000588 | Amines |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |