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Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. However, few studies have carefully evaluated the impact of volume of injection of local anesthetic into the adductor canal on motor weakness or pain control. The ability to achieve similar pain control with decreased volumes of local anesthetic would allow the surgery team to apply more local anesthetic to posterior knee structures. Decreased volumes of local anesthetic may also be associated with a decreased risk of local anesthetic toxicity. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, the investigators hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of volume of injection of local anesthetic into the adductor canal on motor strength.
Postoperative analgesia for total knee arthroplasty (TKA) is incredibly important as it allows for effective physical therapy and ultimately ensures proper function of the implanted joint hardware. Unfortunately, TKA is oftentimes associated with pain severe enough to limit participation in physical therapy which can ultimately result in prolonged hospitalizations and perhaps decreased joint function. A number of strategies have been reported to decrease the pain associated with TKA. Opioids are commonly utilized but they can be associated with a number of potential side effects including nausea, itching, respiratory depression, tolerance and the potential for abuse. Epidural analgesia has been utilized for postoperative analgesia but this strategy requires urinary catheterization (potential source of increased incidence of urinary tract infections), causes significant vasodilation with resulting hypotension and can cause bilateral lower extremity weakness that can undermine efforts at early physical therapy and rehabilitation. Femoral nerve blockade and femoral nerve catheters have the potential to decrease pain in the anterior knee but use of this technique is limited by incomplete analgesia and quadriceps motor weakness. Some groups have advocated for the substitution or addition of sciatic or obturator nerve blocks to femoral nerve blockade but this is at the expense of increased lower extremity weakness and little potential clinical benefit.1-5
In an effort to balance the need for effective postoperative analgesia with the need to maintain lower extremity muscle strength for active participation in physical therapy, a number of groups have begun to evaluate the adductor canal block. The adductor canal is located in the middle 1/3 of the thigh and includes the saphenous nerve and nerve to the vastus medialis. The primary advantage to adductor canal blockade versus femoral nerve blockade is a potential sparing of the nerves to the quadriceps muscle and therefore preservation of lower extremity motor strength.6-8 Kwofie et al reported in a study of 16 volunteers that there was no change in quadriceps strength or hip adduction following the injection of 15 ml of local anesthetic. This is interesting as the obturator nerve is reported to travel within the adductor canal and is responsible for hip adduction. Kwofie et al also reported that SSACNB resulted in significantly decreased impairments with balance compared to a SSFNB.9
To this point, the majority of studies evaluating adductor canal blockade have focused on continuous techniques and little has been done to evaluate single shot techniques. Continuous techniques have the potential to extend analgesia but this is at the expense of increased cost, effort, resource utilization and potentially increased risk of infection.
The safety of CACNB technique was highlighted by a study by Henningsen et al where no cases of nerve injury related to analgesic technique were reported in a series of 97 patients.10 Andersen et al compared a CACNB vs control in 40 patients and found that the intervention group reported decreased pain and sleep disturbances while retaining the ability to ambulate soon after surgery.11 Mudumbai et al evaluated 180 patients undergoing TKA and discovered that continuous adductor canal nerve blockade (CACNB) relative to continuous femoral nerve blockade (CFNB) resulted in greater ability to ambulate (37 m vs 6 m) on POD 1 and similar pain scores.8 Jaeger et al examined a similar group of 54 patients presenting for TKA and found that CACNB relative to CFNB resulted in decreased quadriceps weakness and no difference in pain, opioid consumption or weakness.12 Jenstrup et al reported that, compared to placebo, CACNB resulted in decreased pain with flexion and opioid consumption.13 Only recently has a study comparing SSACNB and SSFNB been published. This study demonstrated that SSACNB resulted in decreased postoperative quadriceps weakness and similar pain control to SSFNB.14 Of interest, previous research has demonstrated that 15 ml 0.5% ropivacaine is required to produce ultrasound guided femoral nerve blockade (including sensory and quadriceps motor weakness) but no such study has yet been done for the adductor canal block.15 It is possible that larger volumes of local anesthetic injected into the adductor canal could result in proximal spread of local anesthetic and increase quadriceps weakness and difficulty ambulating. It is also possible that decreased volumes of injection may result in inferior pain control and difficulties participating in physical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 ml | Experimental | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
|
| 10 ml | Experimental | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
|
| 20 ml | Experimental | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adductor Canal Block | Procedure | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter Walk Test | This will be evaluated by determining how quickly a patient is able to ambulate over 10 meters on POD 1 (10 meter walk test). | 24 hours postoperatively following total knee arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid Requirements will be retrieved from the patient's electronic medical record | PACU Discharge through 24 hours postoperatively |
| Pain With Activity at 24 Hours | Patient pain will be assessed by having participants describe pain using Numerical Ranking Scale (NRS) with a total score of 0-10 where 0 is no pain and 10 is the worst pain imaginable. Location of pain will also be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| FG001 | 10 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| FG002 | 20 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 10 Meter Walk Test | This will be evaluated by determining how quickly a patient is able to ambulate over 10 meters on POD 1 (10 meter walk test). | Incomplete data responsible for discrepancies between number of subjects enrolled and data reported. | Posted | Mean | Standard Deviation | Seconds | 24 hours postoperatively following total knee arthroplasty |
|
48 Hours
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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 | 5 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristopher Schroeder | University of Wisconsin School of Medicine | 608-263-8100 | kmschro1@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2016 | Jun 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Adductor Canal Block | Drug | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
|
|
| 24 Hours Following Surgery |
| Percentage Change in Knee Extension Strength From Baseline | Patient strength will be assessed by asking subjects to maximally adduct their leg or extend their knee for five seconds. Subjects will be asked to repeat this measurement three times at each measurement (pre-block, 15 minutes post-block, 24 hours post-block and 48 hours post-block). Strength measurements will be made with the Kiio strength monitoring device. | 24 Hours Following Surgery |
| Number of Participants With Nausea at 24 Hours | Need for antiemetic therapy will be assessed through evaluation of the electronic medical record. | Perioperative through 48 hours postoperatively |
| BG001 | 10 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| BG002 | 20 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index kg/m2 | Mean | Standard Deviation | kg/m^2 |
|
| ASA Physical Status Classification System Score | Measure Description: ASA I- A normal healthy patient. ASA II- A patient with mild systemic disease. ASA III- A patient with severe systemic disease. ASA IV- A patient with severe systemic disease that is a constant threat to life. ASA V- A moribund patient who is not expected to survive without the operation. ASA VI- A declared brain-dead patient whose organs are being removed for donor purposes. | Median | Full Range | units on a scale |
|
| OG001 | 10 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
| OG002 | 20 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. |
|
|
| Secondary | Opioid Consumption | Opioid Requirements will be retrieved from the patient's electronic medical record | Posted | Mean | Standard Deviation | Morphine Equivalents (mg) | PACU Discharge through 24 hours postoperatively |
|
|
|
| Secondary | Pain With Activity at 24 Hours | Patient pain will be assessed by having participants describe pain using Numerical Ranking Scale (NRS) with a total score of 0-10 where 0 is no pain and 10 is the worst pain imaginable. Location of pain will also be assessed. | Incomplete data responsible for discrepancies between number of subjects enrolled and data reported. | Posted | Mean | Standard Deviation | Scores on a scale | 24 Hours Following Surgery |
|
|
|
| Secondary | Percentage Change in Knee Extension Strength From Baseline | Patient strength will be assessed by asking subjects to maximally adduct their leg or extend their knee for five seconds. Subjects will be asked to repeat this measurement three times at each measurement (pre-block, 15 minutes post-block, 24 hours post-block and 48 hours post-block). Strength measurements will be made with the Kiio strength monitoring device. | Incomplete data responsible for discrepancies between number of subjects enrolled and data reported. | Posted | Mean | Standard Deviation | percentage change of Baseline Strength | 24 Hours Following Surgery |
|
|
|
| Secondary | Number of Participants With Nausea at 24 Hours | Need for antiemetic therapy will be assessed through evaluation of the electronic medical record. | Posted | Count of Participants | Participants | Perioperative through 48 hours postoperatively |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 10 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 20 ml | Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. Adductor Canal Block: Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| Male |
|