Osteoarthritis
Conditions
Keywords
Nerve Block, Rehabilitation, Knee Replacement, Total
Brief summary
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.
Detailed description
A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block. Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours. Time to reach discharge criteria based on physical therapy assessments will also be measured.
Interventions
DRUGBupivacaine
DRUGMorphine
DRUGMethylprednisolone
DRUGCefazolin
DRUGNormal saline
DRUGMidazolam
DRUGPropofol
DRUGDexamethasone
DEVICE8 MHz. Chiba needle, 22 G / 4 inches
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon * Age 18 to 80 years * Planned use of regional anesthesia * Ability to follow study protocol * English speaking (secondary outcomes include questionnaires validated in English only)
Exclusion criteria
Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Meet Physical Therapy Discharge Criteria | First 3 days post-operatively | Time to reach physical therapy (PT) goals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain Score With Movement POD2 | 48 hours after surgery | NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable. |
| Opioid Consumption Postoperative Day (POD) 1 | 0-24 hours postoperatively | Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents) |
| Opioid Consumption POD2 | 24-48 hours postoperative | Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed. |
| Hospital Length of Stay | Average of 3 days | Measured in minutes. |
| Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1 | 24 hours after operating room discharge | Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable. |
| Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively | 24-48 hours postoperative | Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable |
| Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively | 0-24 hours postoperatively | Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable |
| Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively | 24-48 hours postoperative | Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels. |
| Knee Society Score (KSS) at 6 Weeks Postoperatively | Post operatively at approximately 6 weeks after surgery | KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score. |
| Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively | Participants will be followed for the duration of 2 days post operatively in the hospital | Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peri-Articular Injections Only Intra-Operatively
* Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
* Surgeon will perform the periarticular injections:
* First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
* Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
* Intravenous sedation with midazolam and propofol.
Bupivacaine
Morphine
Methylprednisolone
Cefazolin
Normal saline
Midazolam
Propofol
Dexamethasone | 56 |
| Peri-Articular Injections and Adductor Canal Block Intra-Operatively
* Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
* Adductor canal block technique:
* Supine position, after IV sedation
* Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
* Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
* 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
* Local anesthetic will be delivered periarterial between 12 and 6 o'clock
* Intravenous sedation with midazolam and propofol.
* First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
* Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
Bupivacaine
Morphine
Methylprednisolone
Cefazolin
Normal saline
Midazolam
Propofol
Dexamethasone
8 MHz. Chiba needle, 22 G / 4 inches | 55 |
| Total | 111 |
Baseline characteristics
| Characteristic | Peri-Articular Injections Only | Total | Peri-Articular Injections and Adductor Canal Block |
|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 9.6 | 65.8 years STANDARD_DEVIATION 8.3 | 66.9 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 105 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) White | 44 Participants | 90 Participants | 46 Participants |
| Region of Enrollment United States | 56 participants | 111 participants | 55 participants |
| Sex: Female, Male Female | 33 Participants | 67 Participants | 34 Participants |
| Sex: Female, Male Male | 23 Participants | 44 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 55 |
| other Total, other adverse events | 0 / 56 | 0 / 55 |
| serious Total, serious adverse events | 0 / 56 | 0 / 55 |
Outcome results
Primary
Time to Meet Physical Therapy Discharge Criteria
Time to reach physical therapy (PT) goals
Time frame: First 3 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Time to Meet Physical Therapy Discharge Criteria | 2109.3 Minutes | Standard Deviation 1232.8 |
| Peri-Articular Injections and Adductor Canal Block | Time to Meet Physical Therapy Discharge Criteria | 1883.1 Minutes | Standard Deviation 846.2 |
Secondary
Hospital Length of Stay
Measured in minutes.
Time frame: Average of 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Hospital Length of Stay | 3491 Minutes | Standard Deviation 1151.7 |
| Peri-Articular Injections and Adductor Canal Block | Hospital Length of Stay | 3394.4 Minutes | Standard Deviation 945.2 |
Secondary
Knee Society Score (KSS) at 6 Weeks Postoperatively
KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score.
Time frame: Post operatively at approximately 6 weeks after surgery
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Knee Society Score (KSS) at 6 Weeks Postoperatively | 85.2 score on a scale | Standard Deviation 20 |
| Peri-Articular Injections and Adductor Canal Block | Knee Society Score (KSS) at 6 Weeks Postoperatively | 75.2 score on a scale | Standard Deviation 17.7 |
Secondary
NRS Pain Score With Movement POD2
NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable.
Time frame: 48 hours after surgery
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | NRS Pain Score With Movement POD2 | 4.7 score on a scale | Standard Deviation 1.6 |
| Peri-Articular Injections and Adductor Canal Block | NRS Pain Score With Movement POD2 | 5.2 score on a scale | Standard Deviation 2.1 |
Secondary
Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.
Time frame: 24 hours after operating room discharge
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1 | 4.3 score on a scale | Standard Deviation 2.6 |
| Peri-Articular Injections and Adductor Canal Block | Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1 | 3.9 score on a scale | Standard Deviation 2.6 |
Secondary
Opioid Consumption POD2
Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed.
Time frame: 24-48 hours postoperative
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Opioid Consumption POD2 | 67.9 mg OME | Standard Deviation 49.1 |
| Peri-Articular Injections and Adductor Canal Block | Opioid Consumption POD2 | 60.1 mg OME | Standard Deviation 48.8 |
Secondary
Opioid Consumption Postoperative Day (POD) 1
Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)
Time frame: 0-24 hours postoperatively
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Opioid Consumption Postoperative Day (POD) 1 | 58.4 mg OME | Standard Deviation 37.8 |
| Peri-Articular Injections and Adductor Canal Block | Opioid Consumption Postoperative Day (POD) 1 | 47.5 mg OME | Standard Deviation 40.3 |
Secondary
Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable.
Time frame: Participants will be followed for the duration of 2 days post operatively in the hospital
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively | 1.5 score on a scale | Standard Deviation 1.8 |
| Peri-Articular Injections and Adductor Canal Block | Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively | 0.8 score on a scale | Standard Deviation 1.6 |
Secondary
Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively
Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable
Time frame: 24-48 hours postoperative
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively | 1.7 score on a scale | Standard Deviation 1.5 |
| Peri-Articular Injections and Adductor Canal Block | Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively | 1.8 score on a scale | Standard Deviation 1.5 |
Secondary
Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively
Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable
Time frame: 0-24 hours postoperatively
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively | 6.7 score on a scale | Standard Deviation 2.5 |
| Peri-Articular Injections and Adductor Canal Block | Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively | 5.3 score on a scale | Standard Deviation 2.9 |
Secondary
Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively
Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels.
Time frame: 24-48 hours postoperative
Population: Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively | 6.9 score on a scale | Standard Deviation 2.3 |
| Peri-Articular Injections and Adductor Canal Block | Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively | 6.6 score on a scale | Standard Deviation 2.3 |