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The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.
Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. |
|
| Placebo | Placebo Comparator | Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain Scores | Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2. Scale range: 0-100 Higher Values = More Pain | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotics Consumption | Narcotics consumption was recorded on postoperative days 0, 1, and 2. | 3 days |
| Knee Range of Motion | Patient knee range of motion was assessed on postoperative days 0, 1 and 2. |
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Inclusion Criteria:
• Age > 25 years old
Exclusion Criteria:
Severe joint malalignment (defined as varus/valgus angle > 20 deg)
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| Name | Affiliation | Role |
|---|---|---|
| George W Brindley, MD | TTUHSC dept. Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TTUHSC Orthopaedic Surgery MS 9436 | Lubbock | Texas | 79430 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. |
| FG001 | Placebo | Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. |
| BG001 | Placebo |
| 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 | Patient Pain Scores | Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2. Scale range: 0-100 Higher Values = More Pain | Posted | Mean | Standard Deviation | units on a scale- VAS | 3 days |
|
|
AE data was collected through the completion of 2 weeks post op visit unless an AE to follow
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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 | Placebo | placebo comparator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative illeus | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Swinford | Texas Tech University Health Sciences Center | 806-743-2569 | nancy.swinford@ttuhsc.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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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| 3 days |
| Patient Restfulness | Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2. | 3 days |
Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Narcotics Consumption | Narcotics consumption was recorded on postoperative days 0, 1, and 2. | Posted | Mean | Standard Deviation | Morphine dose equivalents | 3 days |
|
|
|
| Secondary | Knee Range of Motion | Patient knee range of motion was assessed on postoperative days 0, 1 and 2. | Posted | Mean | Standard Deviation | Degrees | 3 days |
|
|
|
| Secondary | Patient Restfulness | Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2. | Posted | Number | Percent(%) of participants | 3 days |
|
|
|
| 2 |
| 17 |
| 0 |
| 17 |
| EG001 | Gabapentin | Active pain control medicine | 1 | 20 | 0 | 20 |
| Traumatic foley insertion | Renal and urinary disorders | Systematic Assessment |
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| Bradycardia and vasovagal syncope | Cardiac disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 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 |
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| Day 2 |
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