Arthroplasty, Replacement, Knee, Nerve Block
Conditions
Brief summary
The purpose of this study is to further investigate the efficacy of adductor canal nerve blocks for pain management after total knee replacement. Specifically we are studying adductor canal nerve blocks in conjunction with epidural anesthesia, which is a combination that has not been extensively researched before. Our question is whether combining these modalities will enhance patient satisfaction after surgery and accelerate patients' readiness to discharge.
Detailed description
Knee replacement surgery has become increasingly more common in the United States with hundreds of thousands of surgeries performed yearly across the country. Despite that, there is no consensus standard of care for optimum pain control regimen after surgery. Pain management after TKA ranges from local tissue injections and patient controlled anesthesia to regional nerve blocks to neuraxial anesthesia. Although regional anesthesia has become more common and widespread, there are wide variations depending on practice setting (academic versus private), equipment available (adductor nerve blocks require ultrasound guidance), level of training of the anesthesiologists and patient selection, among other factors. Another part of the reason for the wide variations in practice is the lack of literature demonstrating clear effectiveness or superiority of one technique over another. To date adductor canal nerve blocks have been mainly studied in comparison with femoral nerve blocks in terms of their efficacy in controlling pain and their ability to preserve motor function. Adductor canal nerve blocks have been shown in the literature to be an effective method for postoperative pain control in total knee replacement surgery. One of the unique benefits of this particular technique is that the adductor canal nerve block is primarily a sensory block, thereby controlling pain without impairing motor strength. This is useful for total knee replacement surgery as pain is controlled while quadriceps muscle strength is preserved. With well functioning muscles patients are able to fully participate in physical therapy with less strength impairment and reduced risk of falling. It is our aim to investigate one multimodal approach that combines the strengths of two proven pain management techniques and thereby improve overall postoperative pain control and patient satisfaction. Our hope is to establish a protocol that is safe and effective for patient care.
Interventions
DEVICEAdductor Canal Nerve Block Catheter
ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The functional ACNB pumps will run 8cc/h.
DEVICEAdductor Canal Nerve Block Sham Catheter
Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
DRUGBupivacaine
In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* end stage degenerative joint disease * enrolled for unilateral total knee arthroplasty at the University of Chicago * age \< 85 * ability to understand and willingness to sign a written informed consent
Exclusion criteria
* age \> 85 * American Society of Anesthesiologists physical status \> 3 * known hypersensitivity to lidocaine, bupivacaine, ropivacaine or other local anesthetic agents * Coagulopathy, specifically INR \> 1.5, Platelets \< 100, therapy with clopidogrel within 5 days prior to surgery, enoxaparin or fondaparinux within the last 24 hours prior to surgery, patients with anti-phospholipid syndrome requiring aggressive anticoagulation perioperatively * History of alcohol or substance abuse (including strong opioids - morphine, oxycodone, methadone, fentanyl, ketobemidone), taking \> 50 mg morphine equivalent daily of opioids * Pre-existing femoral neuropathy or radiculopathy * Patients with poor ability to communicate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morphine Equivalents | 12 hours postoperatively and 20 hours after placement of catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Therapy Ambulation Distance | Daily on postoperative days one and two | — |
| Number of Hospital Days Until Discharge Criteria Are Met | within first 3 days (plus or minus 3 days) after surgery | — |
| Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site | within first 3 days (plus or minus 3 days) after surgery | — |
| Visual Analog Score for Pain | 12 hours postoperatively and 20 hours after placement of catheter | The visual analog scale (VAS) is a pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single mark placed at one point along the length of a line that represents a continuum between the two ends of the scale-no pain on the left end of the scale (equal to a score of 0) and the worst pain on the right end of the scale (equal to a score of 100). |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 3 and 6 weeks | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales yields a total WOMAC score. |
| Range of Motion | postoperative day 1 and 2 | Knee range of motion (ROM) was measured (in degrees) during physical therapy. |
| Range of Motion at 3 and 6 Week Follow up | 3 and 6 weeks | — |
| Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter | within first 3 days (plus or minus 3 days) after surgery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr. | 32 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the | 39 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Placement of AC Block vs Sham | Lost to Follow-up | 0 | 1 |
| After Placement of AC Block vs Sham | Protocol Violation | 3 | 2 |
| Prior to Intervention | Protocol Violation | 40 | 35 |
| Prior to Intervention | Withdrawal by Subject | 8 | 6 |
Baseline characteristics
| Characteristic | Epidural Catheter With Adductor Canal Nerve Block Catheter | Total | Epidural Catheter Without Adductor Canal Nerve Block Catheter |
|---|---|---|---|
| Age, Continuous | 64.44 years STANDARD_DEVIATION 8.77 | 63.87 years STANDARD_DEVIATION 9.45 | 63.18 years STANDARD_DEVIATION 10.35 |
| American Society of Anaesthesiologists Score | 2.79 units on a scale STANDARD_DEVIATION 0.41 | 2.68 units on a scale STANDARD_DEVIATION 0.47 | 2.66 units on a scale STANDARD_DEVIATION 0.48 |
| Body Mass Index (Kg/m^2) | 33.58 kg/m^2 STANDARD_DEVIATION 7.11 | 33.94 kg/m^2 STANDARD_DEVIATION 6.65 | 34.38 kg/m^2 STANDARD_DEVIATION 6.14 |
| knee extension (deg) | 4.24 degrees STANDARD_DEVIATION 7.14 | 3.02 degrees STANDARD_DEVIATION 5.78 | 1.54 degrees STANDARD_DEVIATION 3 |
| knee flexion (deg) | 97.41 degrees STANDARD_DEVIATION 26.23 | 100.13 degrees STANDARD_DEVIATION 23.12 | 103.43 degrees STANDARD_DEVIATION 18.62 |
| knee Range of motion (deg) | 93.18 degrees STANDARD_DEVIATION 27.24 | 97.11 degrees STANDARD_DEVIATION 24.43 | 101.89 degrees STANDARD_DEVIATION 19.97 |
| Sex: Female, Male Female | 30 Participants | 55 Participants | 25 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 7 Participants |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 50.78 units on a scale STANDARD_DEVIATION 18.94 | 51.19 units on a scale STANDARD_DEVIATION 16.85 | 51.68 units on a scale STANDARD_DEVIATION 14.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 41 |
| other Total, other adverse events | 0 / 35 | 0 / 41 |
| serious Total, serious adverse events | 0 / 35 | 0 / 41 |
Outcome results
Primary
Morphine Equivalents
Time frame: 12 hours postoperatively and 20 hours after placement of catheter
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Morphine Equivalents | 12 hours postoperatively | 11.9 milligrams of morphine | Standard Deviation 14 |
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Morphine Equivalents | 20 hours after placement of catheter | 96.5 milligrams of morphine | Standard Deviation 47 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Morphine Equivalents | 12 hours postoperatively | 12.5 milligrams of morphine | Standard Deviation 15 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Morphine Equivalents | 20 hours after placement of catheter | 73.9 milligrams of morphine | Standard Deviation 38 |
Secondary
Number of Hospital Days Until Discharge Criteria Are Met
Time frame: within first 3 days (plus or minus 3 days) after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Number of Hospital Days Until Discharge Criteria Are Met | 2.42 Days | Standard Deviation 0.86 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Number of Hospital Days Until Discharge Criteria Are Met | 2.67 Days | Standard Deviation 1.1 |
Secondary
Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter
Time frame: within first 3 days (plus or minus 3 days) after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter | 0 Participants |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter | 0 Participants |
Secondary
Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site
Time frame: within first 3 days (plus or minus 3 days) after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site | 0 Participants |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site | 0 Participants |
Secondary
Physical Therapy Ambulation Distance
Time frame: Daily on postoperative days one and two
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Physical Therapy Ambulation Distance | Postoperative Day 1 | 13.8 meters | Standard Deviation 15.6 |
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Physical Therapy Ambulation Distance | Postoperative Day 2 | 32.5 meters | Standard Deviation 26.2 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Physical Therapy Ambulation Distance | Postoperative Day 1 | 17.6 meters | Standard Deviation 21 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Physical Therapy Ambulation Distance | Postoperative Day 2 | 39.4 meters | Standard Deviation 31.8 |
Secondary
Range of Motion
Knee range of motion (ROM) was measured (in degrees) during physical therapy.
Time frame: postoperative day 1 and 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Range of Motion | Postoperative Day 1 | 51.4 degrees | Standard Deviation 17 |
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Range of Motion | Postoperative Day 2 | 71.3 degrees | Standard Deviation 19 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Range of Motion | Postoperative Day 1 | 40.6 degrees | Standard Deviation 14 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Range of Motion | Postoperative Day 2 | 62.5 degrees | Standard Deviation 21 |
Secondary
Range of Motion at 3 and 6 Week Follow up
Time frame: 3 and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Range of Motion at 3 and 6 Week Follow up | 3 weeks | 98.2 degrees | Standard Deviation 11.5 |
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Range of Motion at 3 and 6 Week Follow up | 6 weeks | 109 degrees | Standard Deviation 14 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Range of Motion at 3 and 6 Week Follow up | 3 weeks | 94.3 degrees | Standard Deviation 13 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Range of Motion at 3 and 6 Week Follow up | 6 weeks | 105 degrees | Standard Deviation 10.2 |
Secondary
Visual Analog Score for Pain
The visual analog scale (VAS) is a pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single mark placed at one point along the length of a line that represents a continuum between the two ends of the scale-no pain on the left end of the scale (equal to a score of 0) and the worst pain on the right end of the scale (equal to a score of 100).
Time frame: 12 hours postoperatively and 20 hours after placement of catheter
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Visual Analog Score for Pain | 12 hours postoperatively | 27.9 mm | Standard Deviation 16 |
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Visual Analog Score for Pain | 20 hours after placement of catheter | 36.4 mm | Standard Deviation 18 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Visual Analog Score for Pain | 12 hours postoperatively | 26.9 mm | Standard Deviation 19 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Visual Analog Score for Pain | 20 hours after placement of catheter | 28.6 mm | Standard Deviation 14 |
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales yields a total WOMAC score.
Time frame: 3 and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 3 weeks | 37.8 score on a scale | Standard Deviation 13 |
| Epidural Catheter Without Adductor Canal Nerve Block Catheter | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 6 weeks | 32.9 score on a scale | Standard Deviation 14 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 3 weeks | 29.1 score on a scale | Standard Deviation 15 |
| Epidural Catheter With Adductor Canal Nerve Block Catheter | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 6 weeks | 27.9 score on a scale | Standard Deviation 17 |