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Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect provider and hospital quality of care. Furthermore, at the core of a healthcare team and healthcare system is the desire to provide patients with the best possible care in order to achieve the best possible outcomes. Providers have the duty to identify areas of needed improvement within the domains of treatment. An area of need that is ubiquitous within medicine is pain control; in this case acute postoperative pain control is the targeted condition. Studies have already shown that better control of acute postoperative pain leads to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient satisfaction and a reduced likelihood of developing chronic pain. Research within the field of pain management has definitively revealed that a combination of different medication regimens can control acute postoperative pain better than narcotics alone. In particular, the medication gabapentin has been shown to improve acute postop pain in many kinds of surgical settings, and it is a safe medication with arguably fewer side effects than narcotics. The investigators know that certain groups of post surgical otolaryngology patients can be at risk for high levels of postoperative pain. Given all of this information, physicians have a responsibility to utilize medications such as gabapentin to do a better job of controlling patient's pain. This investigation is a quality improvement project designed to elucidate the benefits of gabapentin in pain management in patients undergoing surgery of the head and neck mucosal surfaces. It will provide much needed data in an understudied population and ultimately will improve the practice of pain management, patient satisfaction and quality of care delivered in the Barnes otolaryngology department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | Gabapentin liquid by mouth or Per Tube 300mg twice a day |
|
| Placebo | Placebo Comparator | Placebo liquid by mouth or Per Tube twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Narcotic Consumption | Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption. | Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. | Once on post-op day 2 or day of discharge, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Townsend, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29710075 | Derived | Townsend M, Liou T, Kallogjeri D, Schoer M, Scott-Wittenborn N, Lindburg M, Bottros M, Jackson RS, Nussenbaum B, Piccirillo JF. Effect of Perioperative Gabapentin Use on Postsurgical Pain in Patients Undergoing Head and Neck Mucosal Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):959-966. doi: 10.1001/jamaoto.2018.0282. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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13 participants were enrolled but withdrew prior to study participation with no medication given. 8 participants withdrew due to patient preference and 5 withdrew due to cancellation of surgery.
The study opened to participant enrollment on 06/24/2016 and closed to participant enrollment on 06/30/2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Gabapentin liquid by mouth or per Tube 300mg twice a day |
| FG001 | Placebo | Placebo liquid by mouth or Per Tube twice a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Gabapentin liquid by mouth or per Tube 300mg twice a day |
| BG001 | Placebo | Placebo liquid by mouth or Per Tube twice a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Daily Narcotic Consumption | Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption. | Posted | Median | Full Range | mg/hour | Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first. |
|
Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
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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 | Gabapentin | Gabapentin liquid by mouth or per Tube 300mg twice a day | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
All subjects were analyzed following intention to treat principles and were included in the final analysis if greater than one night of admission was achieved before study participation ended.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melanie Townsend, M.D. | Washington University School of Medicine | 314-362-4470 | townsendm@wustl.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 | Apr 11, 2017 | Apr 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
| Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain |
-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. |
| Once on post-op day 2 or day of discharge, whichever comes first |
| Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. | Once on post-op day 2 or day of discharge, whichever comes first |
| Mean Pain With Resting Score as Measured by VAS |
| Baseline through post operative day 3 |
| Mean Pain With Coughing Score as Measured by VAS |
| Baseline through post operative day 3 |
| Mean Pain With Swallowing Score as Measured by VAS |
| Baseline through post operative day 3 |
| Change in surgery plan |
|
| Change to outpatient status |
|
| Withdrawal by Subject |
|
| Return to operating room |
|
| Delirium |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participant's opinion on effectiveness of narcotic pain medication | Some participants were not included as they had never had narcotic pain medication prior to surgery. | Count of Participants | Participants |
|
| Participant's experience with significant amount of daily pain | Participants were asked about daily pain aside from the pain due to the current head and neck condition. | 3 responses are missing because surveys were not given (1 in the gabapentin arm and 2 in the placebo arm) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. | The participants who did not answer this question on the survey were not evaluable for this outcome measure. | Posted | Count of Participants | Participants | Once on post-op day 2 or day of discharge, whichever comes first |
|
|
|
|
| Secondary | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. | Posted | Count of Participants | Participants | Once on post-op day 2 or day of discharge, whichever comes first |
|
|
|
| Secondary | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. | Posted | Count of Participants | Participants | Once on post-op day 2 or day of discharge, whichever comes first |
|
|
|
|
| Secondary | Mean Pain With Resting Score as Measured by VAS |
| Posted | Mean | Standard Deviation | mm | Baseline through post operative day 3 |
|
|
|
|
| Secondary | Mean Pain With Coughing Score as Measured by VAS |
| Posted | Mean | Standard Deviation | mm | Baseline through post operative day 3 |
|
|
|
|
| Secondary | Mean Pain With Swallowing Score as Measured by VAS |
| Posted | Mean | Standard Deviation | mm | Baseline through post operative day 3 |
|
|
|
|
| 55 |
| 0 |
| 55 |
| 46 |
| 55 |
| EG001 | Placebo | Placebo liquid by mouth or Per Tube twice a day | 1 | 55 | 0 | 55 | 50 | 55 |
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Airway bleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Airway edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Allergic contact dermatitis | Immune system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
|
| Bleeding at wound site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bloody sputum | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Blurry vision | Eye disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Congestive heart failure exacerbation | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Delerium | Psychiatric disorders | Systematic Assessment |
|
| Delirium/alcohol withdrawal | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Diplopia | Eye disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elevated alkaline phosphatase | Investigations | Systematic Assessment |
|
| Elevated liver enzymes | Investigations | Systematic Assessment |
|
| Elevated white blood cells | Blood and lymphatic system disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Eye tingling | Eye disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flap necrosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Hematoma at flap site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hemorrhage at resection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoparathyroidism | Endocrine disorders | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Iatrogenic bradycardia | Cardiac disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Laryngeal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Left arm surgical site cellulitis | Infections and infestations | Systematic Assessment |
|
| Left neck numbness | Nervous system disorders | Systematic Assessment |
|
| Left shoulder weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Left upper extremity swelling | General disorders | Systematic Assessment |
|
| Microcytic anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Myasthenia gravis exacerbation | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neck fistula | General disorders | Systematic Assessment |
|
| Neck hematoma | Vascular disorders | Systematic Assessment |
|
| Neck infection | Infections and infestations | Systematic Assessment |
|
| Nonsustained ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Oral wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Oropharyngeal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Orthostasis | Vascular disorders | Systematic Assessment |
|
| Oxygen desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Parasthesia (right foot) | Nervous system disorders | Systematic Assessment |
|
| Pharyngeal leak | Gastrointestinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pressure ulcer - coccyx | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right upper extremity tingling | Nervous system disorders | Systematic Assessment |
|
| Sensation of reflux/burning with tube feeds | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Stoma bleeding | General disorders | Systematic Assessment |
|
| Stoma dehiscence | Gastrointestinal disorders | Systematic Assessment |
|
| Superficial dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Superior thryroid artery bleed hematemesis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Surgical site infection (MRSA) | Infections and infestations | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Tongue edema | Gastrointestinal disorders | Systematic Assessment |
|
| Tracheitis | Infections and infestations | Systematic Assessment |
|
| Tracheostomy site bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Weight loss | Investigations | Systematic Assessment |
|
| Wound breakdown | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Wound necrosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypochloremia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Usually/Always |
|
| Usually |
|
| Always |
|
| Neutral |
|
| Somewhat dissatisfied |
|
| Dissatisfied |
|
| Post-operative Day 1 7PM |
|
| Post-operative Day 2 7AM |
|
| Post-operative Day 2 10AM |
|
| Post-operative Day 2 7PM |
|
| Post-operative Day 3 7AM |
|
| Mean Difference (Final Values) |
| 8.7 |
| 2-Sided |
| 95 |
| -2.9 |
| 20.3 |
This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM. |
| Superiority |
| Mean Difference (Final Values) | 7.2 | 2-Sided | 95 | -4.6 | 18.9 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM. | Superiority |
| Mean Difference (Final Values) | 5.1 | 2-Sided | 95 | -6.6 | 16.8 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM. | Superiority |
| Mean Difference (Final Values) | 7.4 | 2-Sided | 95 | -3.6 | 18.3 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM. | Superiority |
| Mean Difference (Final Values) | 8.0 | 2-Sided | 95 | -5.6 | 21.6 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM. | Superiority |
| Mean Difference (Final Values) | 10.1 | 2-Sided | 95 | -3.5 | 23.8 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM. | Superiority |
| Post-operative Day 1 7PM |
|
| Post-operative Day 2 7AM |
|
| Post-operative Day 2 10AM |
|
| Post-operative Day 2 7PM |
|
| Post-operative Day 3 7AM |
|
| Mean Difference (Final Values) |
| 9.1 |
| 2-Sided |
| 95 |
| -3.4 |
| 21.6 |
This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM. |
| Superiority |
| Mean Difference (Final Values) | 6.3 | 2-Sided | 95 | -6.1 | 18.6 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM. | Superiority |
| Mean Difference (Final Values) | 5.3 | 2-Sided | 95 | -7.3 | 17.8 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM. | Superiority |
| Mean Difference (Final Values) | 11.2 | 2-Sided | 95 | -1.4 | 23.8 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM. | Superiority |
| Mean Difference (Final Values) | 14.9 | 2-Sided | 95 | -0.1 | 29.9 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM. | Superiority |
| Mean Difference (Final Values) | 11.6 | 2-Sided | 95 | -2.8 | 26.0 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM. | Superiority |
| Post-operative Day 1 7PM |
|
| Post-operative Day 2 7AM |
|
| Post-operative Day 2 10AM |
|
| Post-operative Day 2 7PM |
|
| Post-operative Day 3 7AM |
|
| Mean Difference (Final Values) |
| 5.3 |
| 2-Sided |
| 95 |
| -8.6 |
| 19.2 |
This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM. |
| Superiority |
| Mean Difference (Final Values) | 10.9 | 2-Sided | 95 | -2.4 | 24.2 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM. | Superiority |
| Mean Difference (Final Values) | 7.0 | 2-Sided | 95 | -6.6 | 20.7 | Superiority | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM. |
| Mean Difference (Final Values) | 8.0 | 2-Sided | 95 | -6.4 | 22.3 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM. | Superiority |
| Mean Difference (Final Values) | 15.7 | 2-Sided | 95 | -0.4 | 31.7 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM. | Superiority |
| Mean Difference (Final Values) | 16.7 | 2-Sided | 95 | 0.0 | 33.4 | This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM. | Superiority |