Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects.
The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function [quicker ambulation with physical therapy (PT), earlier return to work, etc.].
Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows:
The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous (IV) Placebo | Placebo Comparator | IV Placebo arm |
|
| IV Ketorolac | Experimental | IV Ketorolac arm |
|
| IV Acetaminophen | Experimental | IV Acetaminophen arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Opioid Use | Measure the impact of treatment on total opioid use during the hospital stay | Hospital stay (2-4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use at 4-6 Weeks | Track opioid use after discharge for the first 4-6 weeks | 4-6 weeks |
| Opioid Use at 3 Months | Track opioid use after discharge for the first 3 months; assess for continued opioid use |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Himo Gang | Research Manager for Spine Research | Study Director |
| Harvinder Sandhu, MD | Associate Professor of Orthopedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Assessed for eligibility (n= 1,372) Excluded (n= 1,194)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IV Ketorolac | IV Ketorolac arm Ketorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| FG001 | Intravenous (IV) Placebo | IV Placebo arm Placebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| FG002 | IV Acetaminophen | IV Acetaminophen arm Acetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis performed on Per-Protocol
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IV Ketorolac | IV Ketorolac arm Ketorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| 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 | Perioperative Opioid Use | Measure the impact of treatment on total opioid use during the hospital stay | Posted | Median | Inter-Quartile Range | oral morphine equivalents (OME) (mmg) | Hospital stay (2-4 days) |
|
2-year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Ketorolac | IV Ketorolac arm Ketorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hypotension tachycardia hypertension DVT hypoxia palpitations other pulmonary arrhythmia bradycardia pulmonary embolism other cardiopulmonary chest pain cough pleural effusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiopulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hypotension tachycardia hypertension DVT hypoxia palpitations other pulmonary arrhythmia bradycardia pulmonary embolism other cardiopulmonary chest pain cough pleural effusion |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Himo Gang | HospitalSS | 917-260-4603 | gangh@HSS.EDU |
Not provided
| 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 | Feb 23, 2023 | Apr 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2017 | Feb 23, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D055013 | Osteoarthritis, Spine |
| D055009 | Spondylosis |
| C535531 | Intervertebral disc disease |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Acetaminophen | Drug | Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
|
|
| Placebo | Drug | Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
|
|
| 3 months |
| Opioid Use at 1 Year | Track opioid use after discharge for the first 1 year; assess for continued opioid use | 1 year |
| Opioid Use at 2 Years | Track total opioid use after discharge for the first 2 years; assess for continued opioid use | 2 years |
| Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | 1 days and 3 days |
| Brief Pain Inventory | The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring. | 1 day and 3 days |
| Opioid Related Side Effects | Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded | Hospital Stay (1-4 days) |
| Perioperative Complications - Drain Output | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded | Hospital Stay (1-4 days) |
| Perioperative Complications - Transfusion Rate | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded | Hospital Stay (1-4 days) |
| Days to Walk 50 ft With PT | Days needed to be able to walk 50ft with PT | Hospital Stay (1-4 days) |
| Length of Stay | Will record date of discharge | Hospital Stay (1-4 days) |
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | pre-operative |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | pre-operative |
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | 3 month follow up |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | 3 month follow up |
| Return to Work | Record return to work | 3 month follow up |
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | 1 year follow up |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | 1 year follow up |
| Return to Work | Record return to work | 1 year follow up |
| Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | 1 year follow up |
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | 2 year follow up |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | 2 year follow up |
| Return to Work | Record return to work | 2 year follow up |
| Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | 2 year follow up |
| BG001 |
| Intravenous (IV) Placebo |
IV Placebo arm Placebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| BG002 | IV Acetaminophen | IV Acetaminophen arm Acetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | IV Acetaminophen | IV Acetaminophen arm Acetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. |
|
|
|
| Secondary | Opioid Use at 4-6 Weeks | Track opioid use after discharge for the first 4-6 weeks | Patient treated Per-Protocol with completed follow-up | Posted | Count of Participants | Participants | 4-6 weeks |
|
|
|
|
| Secondary | Opioid Use at 3 Months | Track opioid use after discharge for the first 3 months; assess for continued opioid use | Patient treated Per-Protocol with completed follow-up | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| Secondary | Opioid Use at 1 Year | Track opioid use after discharge for the first 1 year; assess for continued opioid use | Patient treated Per-Protocol with completed follow-up | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Opioid Use at 2 Years | Track total opioid use after discharge for the first 2 years; assess for continued opioid use | Patient treated Per-Protocol with completed follow-up | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | Analysis performed on patient with data completed. | Posted | Median | Inter-Quartile Range | units on a scale | 1 days and 3 days |
|
|
|
|
| Secondary | Brief Pain Inventory | The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring. | Patient treated Per-Protocol with completed follow-up | Posted | Median | Inter-Quartile Range | score on a scale | 1 day and 3 days |
|
|
|
|
| Secondary | Opioid Related Side Effects | Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded | Patient treated Per-Protocol with completed follow-up | Posted | Count of Participants | Participants | Hospital Stay (1-4 days) |
|
|
|
| Secondary | Perioperative Complications - Drain Output | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded | Patient treated Per-Protocol with completed data | Posted | Median | Inter-Quartile Range | mL | Hospital Stay (1-4 days) |
|
|
|
|
| Secondary | Perioperative Complications - Transfusion Rate | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded | Patient treated Per-Protocol with completed data | Posted | Count of Participants | Participants | Hospital Stay (1-4 days) |
|
|
|
|
| Secondary | Days to Walk 50 ft With PT | Days needed to be able to walk 50ft with PT | Posted | Count of Participants | Participants | Hospital Stay (1-4 days) |
|
|
|
|
| Secondary | Length of Stay | Will record date of discharge | Posted | Mean | Inter-Quartile Range | Hour | Hospital Stay (1-4 days) |
|
|
|
|
| Secondary | Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | Patient treated Per-Protocol with completed follow-up | Posted | Mean | Standard Deviation | score on a scale | pre-operative |
|
|
|
|
| Secondary | Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | Patient treated Per-Protocol with pre-operative ODI | Posted | Mean | Standard Deviation | percentage | pre-operative |
|
|
|
|
| Secondary | Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | Patient treated Per-Protocol with completed follow-up | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up |
|
|
|
|
| Secondary | Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | patient treated Per-Protocol with completed follow-up | Posted | Mean | Standard Deviation | percentage | 3 month follow up |
|
|
|
|
| Secondary | Return to Work | Record return to work | Patient treated Per-Protocol with completed follow-up | Posted | Count of Participants | Participants | 3 month follow up |
|
|
|
| Secondary | Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | Patient treated Per-Protocol with completed follow-up | Posted | Mean | Standard Deviation | score on a scale | 1 year follow up |
|
|
|
| Secondary | Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | Patient treated Per-Protocol with completed follow-up | Posted | Mean | Standard Deviation | percentage | 1 year follow up |
|
|
|
| Secondary | Return to Work | Record return to work | Posted | Count of Participants | Participants | 1 year follow up |
|
|
|
| Secondary | Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | Patient treated Per-Protocol with completed follow-up | Posted | Median | Inter-Quartile Range | score on a scale | 1 year follow up |
|
|
|
| Secondary | Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | Patient treated Per-Protocol with completed follow-up | Posted | Mean | Standard Deviation | score on a scale | 2 year follow up |
|
|
|
| Secondary | Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | Patient treated Per-Protocol with completed follow-up | Posted | Mean | Standard Deviation | percentage | 2 year follow up |
|
|
|
| Secondary | Return to Work | Record return to work | Patient treated Per-Protocol with completed follow-up | Posted | Count of Participants | Participants | 2 year follow up |
|
|
|
| Secondary | Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | Posted | Median | Inter-Quartile Range | score on a scale | 2 year follow up |
|
|
|
| 0 |
| 44 |
| 10 |
| 44 |
| 40 |
| 44 |
| EG001 | Intravenous (IV) Placebo | IV Placebo arm Placebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | 0 | 43 | 9 | 43 | 40 | 43 |
| EG002 | IV Acetaminophen | IV Acetaminophen arm Acetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | 0 | 41 | 11 | 41 | 38 | 41 |
|
| cardiovascular | Endocrine disorders | Systematic Assessment | acute blood loss anemia |
|
| Fall (mechanical) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fall (syncope) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | nausea nausea/vomiting distention constipation ileus diarrhea other gastrointestinal pain abdominal pain |
|
| Implant-related | Surgical and medical procedures | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment | UTI Superficial infection deep infection |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain |
|
| Neurologic | Nervous system disorders | Systematic Assessment | Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit |
|
| Operative | Surgical and medical procedures | Systematic Assessment | Dural Tear Monitoring anomaly (SSEP) Monitoring Anomaly vascular injury |
|
| Radiographic | Musculoskeletal and connective tissue disorders | Systematic Assessment | adjacent segment degeneration pseudarthrosis |
|
| Renal | Renal and urinary disorders | Systematic Assessment | oliguria urinary retention hematuria Electrolyte imbalance |
|
| Vascular | Vascular disorders | Systematic Assessment | edema |
|
| Wound | Skin and subcutaneous tissue disorders | Systematic Assessment | prolonged drainage seroma swelling redness pain |
|
| Other | General disorders | Systematic Assessment | ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia |
|
|
| cardiovascular | Endocrine disorders | Systematic Assessment | acute blood loss anemia |
|
| fall (mechanical) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| fall (syncope) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| gastrointestinal | Gastrointestinal disorders | Systematic Assessment | nausea nausea/vomiting distention constipation ileus diarrhea other gastrointestinal pain abdominal pain |
|
| implant-related | Surgical and medical procedures | Systematic Assessment |
|
| infection | Infections and infestations | Systematic Assessment | UTI Superficial infection deep infection |
|
| musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain |
|
| neurologic | Nervous system disorders | Systematic Assessment | Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit |
|
| operative | Surgical and medical procedures | Systematic Assessment | Dural Tear Monitoring anomaly (SSEP) Monitoring Anomaly vascular injury |
|
| radiographic | Musculoskeletal and connective tissue disorders | Systematic Assessment | adjacent segment degeneration pseudarthrosis |
|
| renal | Renal and urinary disorders | Systematic Assessment | oliguria urinary retention hematuria Electrolyte imbalance Other |
|
| vascular | Vascular disorders | Systematic Assessment | edema |
|
| wound | Skin and subcutaneous tissue disorders | Systematic Assessment | prolonged drainage seroma swelling redness pain |
|
| other | General disorders | Systematic Assessment | ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia |
|
Not provided
Not provided
| D009140 |
| Musculoskeletal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| POD1 - Best pain level |
|
|
| POD1 - Worst pain level |
|
|
| POD3 - Current pain level |
|
|
| PDO3 - Best pain level |
|
|
| POD3 - Worst pain level |
|
|
| Kruskal-Wallis |
| 0.896 |
| Equivalence |
Two-sided 95% confidence interval |
| The distribution of POD1 - Worst pain level is the same across the 3 arms | Kruskal-Wallis | 0.004 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Current pain level is the same across the 3 arms | Kruskal-Wallis | 0.325 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Best pain level is the same across the 3 arms | Kruskal-Wallis | 0.283 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Worst pain level is the same across the 3 arms | Kruskal-Wallis | 0.610 | Equivalence | Two-sided 95% confidence interval |
| POD1 - Pain has interfered with Mood |
|
|
| POD1 - Pain has interfered with Walking Ability |
|
|
| POD1 - Pain has interfered with Normal work |
|
|
| POD1 - Pain has interfered with Relation with other |
|
|
| POD1 - Pain has interfered with Sleep |
|
|
| POD1 - Pain has interfered with Enjoyment of life |
|
|
| POD3 - Pain has interfered with General Activity |
|
|
| POD3 - Pain has interfered with Mood |
|
|
| POD3 - Pain has interfered with Walking Ability |
|
|
| POD3 - Pain has interfered with Normal work |
|
|
| POD3 - Pain has interfered with Relation with other |
|
|
| POD3 - Pain has interfered with Sleep |
|
|
| POD3 - Pain has interfered with Enjoyment of life |
|
|
The distribution of POD1 - Pain has interfered with Mood is the same across the 3 arms
| Kruskal-Wallis |
| 0.294 |
| Equivalence |
Two-sided 95% confidence interval |
| The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 arms | Kruskal-Wallis | 0.016 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 arms | Kruskal-Wallis | 0.082 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 arms | Kruskal-Wallis | 0.117 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 arms | Fisher Exact | 0.061 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 arms | Kruskal-Wallis | 0.023 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 arms | Kruskal-Wallis | 0.681 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Pain has interfered with Mood is the same across the 3 arms | Kruskal-Wallis | 0.405 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 arms | Kruskal-Wallis | 0.458 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 arms | Kruskal-Wallis | 0.482 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 arms | Kruskal-Wallis | 0.544 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 arms | Kruskal-Wallis | 0.202 | Equivalence | Two-sided 95% confidence interval |
| The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 arms | Kruskal-Wallis | 0.580 | Equivalence | Two-sided 95% confidence interval |
| No |
|
| POD1 - Vomiting? |
|
|
| POD1 - Constipation? |
|
|
| POD1 - Difficulty passing urine? |
|
|
| POD1 - Difficulty concentrating? |
|
|
| POD1 - Drowsiness/Difficulty Staying Awake? |
|
|
| POD1 - Lightheaded or dizzy? |
|
|
| POD1 - Feeling confused? |
|
|
| POD1 - Fatigue? |
|
|
| POD1 - Itchiness? |
|
|
| POD1 - Dry mouth? |
|
|
| POD1 - Headache? |
|
|
| POD3 - Nausea? |
|
|
| POD3 - Vomiting? |
|
|
| POD3 - Constipation? |
|
|
| POD3 - Difficulty passing urine? |
|
|
| POD3 - Difficulty concentrating? |
|
|
| POD3 - Drowsiness/Difficulty Staying Awake? |
|
|
| POD3 - Lightheaded or dizzy? |
|
|
| POD3 - Feeling confused? |
|
|
| POD3 - Fatigue? |
|
|
| POD3 - Itchiness? |
|
|
| POD3 - Dry mouth? |
|
|
| POD3 - Headache? |
|
|
|
| Total Drain output 72H |
|
| Total Drain output at discharge |
|
| Kruskal-Wallis |
| 0.906 |
| Equivalence |
Two-sided 95% confidence interval |
| The distribution of Total Drain output at 72H is the same across the 3 arms | Kruskal-Wallis | 0.926 | Equivalence | Two-sided 95% confidence interval |
| The distribution of Total Drain output at Discharge is the same across the 3 arms | Kruskal-Wallis | 0.934 | Equivalence | Two-sided 95% confidence interval |
| POD2 and after |
|
| Kruskal-Wallis |
| 0.030 |
| Equivalence |
Two-sided 95% confidence interval |
|
| ANOVA |
| 0.444 |
| Equivalence |
Two-sided 95% confidence interval |
|
| ANOVA |
| 0.767 |
| Equivalence |
Two-sided 95% confidence interval |
| Complete disability |
|
| Lighter job |
|
| Original job. part time |
|
| Original job, full time |
|
|
| Complete disability |
|
| Lighter job |
|
| Original job, part time |
|
| Original job, full time |
|
|
| 1-year - Worst pain level |
|
|
| Complete disability |
|
| Lighter job |
|
| Original job, part time |
|
| Original job, full time |
|
|
| 2 year - Worst pain level |
|