Postoperative Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGGabapentin
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* • Age \> 25 years old * Primary osteoarthritis of the knee * Must be undergoing unilateral total knee arthroplasty * Anesthesia assesment score I, II, or III
Exclusion criteria
* Severe joint malalignment (defined as varus/valgus angle \> 20 deg) * Use of gabapentin pre-operatively * History of chronic pain (currently under treatment) * History of substance abuse * Impaired kidney function (defined as creatinine \> 1.5) * Epilepsy (currently on medication for treatment) * Known allergy to Gabapentin * Known history of depression or suicidal thoughts and behaviors * Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Scores | 3 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotics Consumption | 3 days | Narcotics consumption was recorded on postoperative days 0, 1, and 2. |
| Knee Range of Motion | 3 days | Patient knee range of motion was assessed on postoperative days 0, 1 and 2. |
| Patient Restfulness | 3 days | Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Placebo 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. | 17 |
| Total | 37 |
Baseline characteristics
| Characteristic | Placebo | Gabapentin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 13 Participants | 24 Participants |
| Age, Continuous | 63.1 Years STANDARD_DEVIATION 11.2 | 61.3 Years STANDARD_DEVIATION 10.1 | 62.1 Years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 17 participants | 20 participants | 37 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 20 |
| serious Total, serious adverse events | 2 / 17 | 1 / 20 |
Outcome results
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
Time frame: 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Patient Pain Scores | Day 0 | 33.6 units on a scale- VAS | Standard Deviation 23.3 |
| Placebo | Patient Pain Scores | Day 1 | 34.9 units on a scale- VAS | Standard Deviation 26.6 |
| Placebo | Patient Pain Scores | Day 2 | 38.0 units on a scale- VAS | Standard Deviation 15.9 |
| Gabapentin | Patient Pain Scores | Day 0 | 40.0 units on a scale- VAS | Standard Deviation 26.1 |
| Gabapentin | Patient Pain Scores | Day 1 | 46.3 units on a scale- VAS | Standard Deviation 30.5 |
| Gabapentin | Patient Pain Scores | Day 2 | 39.6 units on a scale- VAS | Standard Deviation 18.8 |
Secondary
Knee Range of Motion
Patient knee range of motion was assessed on postoperative days 0, 1 and 2.
Time frame: 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Knee Range of Motion | Day 0 | 53.12 Degrees | Standard Deviation 17.72 |
| Placebo | Knee Range of Motion | Day 1 | 66.81 Degrees | Standard Deviation 20.54 |
| Placebo | Knee Range of Motion | Day 2 | 67.47 Degrees | Standard Deviation 23.13 |
| Gabapentin | Knee Range of Motion | Day 0 | 57.85 Degrees | Standard Deviation 17.7 |
| Gabapentin | Knee Range of Motion | Day 1 | 62.74 Degrees | Standard Deviation 19.44 |
| Gabapentin | Knee Range of Motion | Day 2 | 65.94 Degrees | Standard Deviation 15.2 |
Secondary
Narcotics Consumption
Narcotics consumption was recorded on postoperative days 0, 1, and 2.
Time frame: 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Narcotics Consumption | Day 0 | 4.16 Morphine dose equivalents | Standard Deviation 9.02 |
| Placebo | Narcotics Consumption | Day 1 | 11.53 Morphine dose equivalents | Standard Deviation 13.9 |
| Placebo | Narcotics Consumption | Day 2 | 11.61 Morphine dose equivalents | Standard Deviation 10.78 |
| Gabapentin | Narcotics Consumption | Day 0 | 7.40 Morphine dose equivalents | Standard Deviation 9.1 |
| Gabapentin | Narcotics Consumption | Day 1 | 25.02 Morphine dose equivalents | Standard Deviation 17.28 |
| Gabapentin | Narcotics Consumption | Day 2 | 21.62 Morphine dose equivalents | Standard Deviation 17.28 |
Secondary
Patient Restfulness
Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.
Time frame: 3 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Restfulness | Day 0 | 35.3 Percent(%) of participants |
| Placebo | Patient Restfulness | Day 1 | 52.9 Percent(%) of participants |
| Placebo | Patient Restfulness | Day 2 | 58.5 Percent(%) of participants |
| Gabapentin | Patient Restfulness | Day 2 | 65.0 Percent(%) of participants |
| Gabapentin | Patient Restfulness | Day 0 | 55.0 Percent(%) of participants |
| Gabapentin | Patient Restfulness | Day 1 | 75.0 Percent(%) of participants |