Arthroplasty, Replacement, Knee
Conditions
Brief summary
The primary aim of this pilot study will be to develop a clinically meaningful, patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of different strategies for achievement of the ideal balance between analgesia and functional mobility following total knee arthroplasty (TKA).
Detailed description
Pain management for total knee replacement (TKR) patients has evolved rapidly over the previous decade. The most recent advances in anesthesia include peripheral nerve blockade, which offers the promise of earlier postoperative mobilization in addition to effective pain relief. The rapidity with which these advancements have been adopted seems to have outpaced the science to support them. The result has been the institution of countless combinations of perioperative pain management strategies in centers nationwide with little standardization, consistency, or objective evidence. The extent to which these various strategies achieve safe and effective perioperative pain control or functional preservation remains poorly defined. This prospective randomized control trial will aim to identify meaningful patient-centric outcome measures, differentiate from among three perioperative TKR anesthetic and analgesic strategies, and provide a template for interdisciplinary collaboration among orthopedic surgeons, anesthesiologists, physical therapists, and patients. With the knowledge gained further study will continue to refine the most optimal early pain control protocol. All primary TKR patients undergoing surgery at the Medical University of South Carolina who are able to receive spinal anesthesia will be randomized prior to surgery to one of three forms of lower limb nerve blockade: 1) Continuous femoral nerve catheter plus single injection sciatic nerve block, 2) Adductor canal catheter plus selective tibial nerve block, 3) Adductor canal catheter alone. All patients will receive additional standardized pain medications as well as early mobilization with physical therapy. The primary outcome measure will be postoperative visual analog pain scale (VAS), with secondary measures to include validated patient-reported outcome measures, objective functional measures (timed-up-and-go (TUG), patient satisfaction scores, length of stay, discharge disposition, and complications. The investigators plan to enroll approximately 90 patients. This will allow us to reach our randomization goal of at least 75 patients while taking into account withdrawals. The 75 patients will be randomized into the three treatment three treatment arms over a 6-month recruitment period, with a 3 month follow-up for patient reported outcome and satisfaction data. A focus group will facilitate patient engagement and provide information for generation of a preference survey to guide future study design.
Interventions
This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.
This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.
This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Sponsors
Study design
Eligibility
Inclusion criteria
* Males and Females 18 years of age or older * Undergoing elective primary total knee arthroplasty * Patient is willing and able to give consent and participate
Exclusion criteria
* Inability to receive spinal anesthesia or peripheral nerve block * Non-ambulatory patients * Non- English speaking patients * Vulnerable populations including prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measurement Via VAS (Visual Analog Scale) | 48 hours after procedure | The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome Measures- Exstension/Knee Buckling | 1-2 days after procedure | Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively. |
| Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care) | Morning of post-op day 1 - 2 days after procedure | Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning. |
| Narcotic Requirements | 48 hours after procedure | Narcotic dosages will be measured and reported as oral morphine milligram equivalents. |
| Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds | Morning of post-op day 1 - 2 days after procedure | Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG). |
| Patient Reported Pain and Function Outcomes | 6 Weeks after procedure | Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100. Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none). |
| Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked | Morning of post-op day 1 - 2 days after procedure | Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between October 2015 and August 2016. Patients were approached for participation in the study during their pre-op medical clearance clinic appointment.
Pre-assignment details
A total of 107 patients undergoing primary TKA met initial eligibility criteria and were offered participation in the trial. 75 total subjects were randomized and considered enrolled to one of three arms of the study. 32 patients were excluded for various reasons prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block Femoral nerve catheter and sciatic nerve block
Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb. | 25 |
| Adductor Canal Catheter and Selective Tibial Block Adductor canal catheter and selective tibial block
Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb. | 25 |
| Adductor Canal Catheter Only Adductor canal catheter only
Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 4 |
Baseline characteristics
| Characteristic | Femoral Nerve Catheter and Sciatic Nerve Block | Adductor Canal Catheter and Selective Tibial Block | Adductor Canal Catheter Only | Total |
|---|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 6.1 | 65.7 years STANDARD_DEVIATION 9.5 | 65.6 years STANDARD_DEVIATION 6.8 | 63.8 years STANDARD_DEVIATION 7.5 |
| Baseline VAS Pain Score | 5 Score on a scale | 6 Score on a scale | 6 Score on a scale | 6 Score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 9 Participants | 7 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 16 Participants | 18 Participants | 52 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 11 Participants | 37 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 14 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 2 / 25 | 5 / 25 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Pain Measurement Via VAS (Visual Analog Scale)
The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.
Time frame: 48 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Pain Measurement Via VAS (Visual Analog Scale) | 4.11 score on a scale | Standard Deviation 0.43 |
| Adductor Canal Catheter and Selective Tibial Block | Pain Measurement Via VAS (Visual Analog Scale) | 4.68 score on a scale | Standard Deviation 0.44 |
| Adductor Canal Catheter Only | Pain Measurement Via VAS (Visual Analog Scale) | 4.36 score on a scale | Standard Deviation 0.42 |
Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.
Time frame: Morning of post-op day 1 - 2 days after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care) | 15.0 score on a scale | Standard Deviation 2 |
| Adductor Canal Catheter and Selective Tibial Block | Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care) | 16.5 score on a scale | Standard Deviation 4 |
| Adductor Canal Catheter Only | Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care) | 16.0 score on a scale | Standard Deviation 2 |
Functional Outcome Measures- Exstension/Knee Buckling
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.
Time frame: 1-2 days after procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Functional Outcome Measures- Exstension/Knee Buckling | Terminal Knee Extension (Yes) (Post Op. Day 2) | 13 number of participants |
| Femoral Nerve Catheter and Sciatic Nerve Block | Functional Outcome Measures- Exstension/Knee Buckling | Any Knee Buckling (Yes) (Post Op. Day 1) | 20 number of participants |
| Femoral Nerve Catheter and Sciatic Nerve Block | Functional Outcome Measures- Exstension/Knee Buckling | Terminal Knee Extension (YES)(Post Op Day 1) | 10 number of participants |
| Femoral Nerve Catheter and Sciatic Nerve Block | Functional Outcome Measures- Exstension/Knee Buckling | Any Knee Buckling (Yes) (PPost Op. Day 2) | 8 number of participants |
| Adductor Canal Catheter and Selective Tibial Block | Functional Outcome Measures- Exstension/Knee Buckling | Any Knee Buckling (Yes) (Post Op. Day 1) | 7 number of participants |
| Adductor Canal Catheter and Selective Tibial Block | Functional Outcome Measures- Exstension/Knee Buckling | Terminal Knee Extension (Yes) (Post Op. Day 2) | 15 number of participants |
| Adductor Canal Catheter and Selective Tibial Block | Functional Outcome Measures- Exstension/Knee Buckling | Any Knee Buckling (Yes) (PPost Op. Day 2) | 4 number of participants |
| Adductor Canal Catheter and Selective Tibial Block | Functional Outcome Measures- Exstension/Knee Buckling | Terminal Knee Extension (YES)(Post Op Day 1) | 16 number of participants |
| Adductor Canal Catheter Only | Functional Outcome Measures- Exstension/Knee Buckling | Terminal Knee Extension (YES)(Post Op Day 1) | 20 number of participants |
| Adductor Canal Catheter Only | Functional Outcome Measures- Exstension/Knee Buckling | Any Knee Buckling (Yes) (PPost Op. Day 2) | 1 number of participants |
| Adductor Canal Catheter Only | Functional Outcome Measures- Exstension/Knee Buckling | Terminal Knee Extension (Yes) (Post Op. Day 2) | 22 number of participants |
| Adductor Canal Catheter Only | Functional Outcome Measures- Exstension/Knee Buckling | Any Knee Buckling (Yes) (Post Op. Day 1) | 8 number of participants |
Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.
Time frame: Morning of post-op day 1 - 2 days after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked | 80 Feet | Standard Deviation 102 |
| Adductor Canal Catheter and Selective Tibial Block | Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked | 155 Feet | Standard Deviation 150 |
| Adductor Canal Catheter Only | Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked | 160 Feet | Standard Deviation 105 |
Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).
Time frame: Morning of post-op day 1 - 2 days after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds | 66.1 seconds | Standard Deviation 32 |
| Adductor Canal Catheter and Selective Tibial Block | Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds | 61.9 seconds | Standard Deviation 29.6 |
| Adductor Canal Catheter Only | Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds | 65.3 seconds | Standard Deviation 39.3 |
Narcotic Requirements
Narcotic dosages will be measured and reported as oral morphine milligram equivalents.
Time frame: 48 hours after procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Narcotic Requirements | 90 milligrams of morphine equivalents |
| Adductor Canal Catheter and Selective Tibial Block | Narcotic Requirements | 107.5 milligrams of morphine equivalents |
| Adductor Canal Catheter Only | Narcotic Requirements | 107 milligrams of morphine equivalents |
Patient Reported Pain and Function Outcomes
Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100. Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).
Time frame: 6 Weeks after procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Patient Reported Pain and Function Outcomes | PROMIS | 37.4 score on a scale | Standard Deviation 4.76 |
| Femoral Nerve Catheter and Sciatic Nerve Block | Patient Reported Pain and Function Outcomes | KOOS Pain | 63.3 score on a scale | Standard Deviation 19 |
| Femoral Nerve Catheter and Sciatic Nerve Block | Patient Reported Pain and Function Outcomes | KOOS Symptom | 61.7 score on a scale | Standard Deviation 21.8 |
| Adductor Canal Catheter and Selective Tibial Block | Patient Reported Pain and Function Outcomes | KOOS Symptom | 62.6 score on a scale | Standard Deviation 16.9 |
| Adductor Canal Catheter and Selective Tibial Block | Patient Reported Pain and Function Outcomes | KOOS Pain | 57.8 score on a scale | Standard Deviation 17 |
| Adductor Canal Catheter and Selective Tibial Block | Patient Reported Pain and Function Outcomes | PROMIS | 41.5 score on a scale | Standard Deviation 6.35 |
| Adductor Canal Catheter Only | Patient Reported Pain and Function Outcomes | PROMIS | 39.2 score on a scale | Standard Deviation 6.42 |
| Adductor Canal Catheter Only | Patient Reported Pain and Function Outcomes | KOOS Pain | 62.6 score on a scale | Standard Deviation 15.8 |
| Adductor Canal Catheter Only | Patient Reported Pain and Function Outcomes | KOOS Symptom | 58.7 score on a scale | Standard Deviation 13.2 |
Patient Reported Pain and Function Outcomes
Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20, the maximum is 100. Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).
Time frame: 3 Months after Procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Femoral Nerve Catheter and Sciatic Nerve Block | Patient Reported Pain and Function Outcomes | KOOS Symptom | 64.3 score on a scale | Standard Deviation 19 |
| Femoral Nerve Catheter and Sciatic Nerve Block | Patient Reported Pain and Function Outcomes | KOOS Pain | 66.8 score on a scale | Standard Deviation 19.8 |
| Femoral Nerve Catheter and Sciatic Nerve Block | Patient Reported Pain and Function Outcomes | PROMIS | 41.1 score on a scale | Standard Deviation 6.92 |
| Adductor Canal Catheter and Selective Tibial Block | Patient Reported Pain and Function Outcomes | KOOS Symptom | 71.7 score on a scale | Standard Deviation 12.9 |
| Adductor Canal Catheter and Selective Tibial Block | Patient Reported Pain and Function Outcomes | KOOS Pain | 72.6 score on a scale | Standard Deviation 18.4 |
| Adductor Canal Catheter and Selective Tibial Block | Patient Reported Pain and Function Outcomes | PROMIS | 45.4 score on a scale | Standard Deviation 7.17 |
| Adductor Canal Catheter Only | Patient Reported Pain and Function Outcomes | KOOS Pain | 70.5 score on a scale | Standard Deviation 17.3 |
| Adductor Canal Catheter Only | Patient Reported Pain and Function Outcomes | PROMIS | 44.4 score on a scale | Standard Deviation 6.04 |
| Adductor Canal Catheter Only | Patient Reported Pain and Function Outcomes | KOOS Symptom | 67.4 score on a scale | Standard Deviation 15.8 |