- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02453360
Adductor Canal Block for Total Knee Arthroplasty
Impact of Volume of Local Anesthetic Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin School of Medicine and Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The subject is scheduled for elective unilateral TKA
- The subject is ≥ 18 years and ≤ 80 years;
- The subject's weight is between 70-120 kg; and
- The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural).
- The patient agrees to receive an adductor canal block.
- American Society of Anesthesiologists class 1-3
Exclusion Criteria:
- Subject is < 18 years of age or >80 years of age;
- Subject is non-English speaking;
- Subject is known or believed to be pregnant;
- Subject is a prisoner;
- Subject has impaired decision-making capacity; per discretion of the Investigator
- Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;
- Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;
- Significant pre-existing neuropathy on the operative limb;
- Significant renal, cardiac or hepatic disease per discretion of the investigator.
- American Society of Anesthesiologists class 4-5
- Known hypersensitivity and/or allergies to local anesthetics
- Chronic Opioid Use (daily or almost daily use of opioids for > 3 months)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
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.
Other Names:
|
|
Experimental: 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.
|
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.
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.
Other Names:
|
|
Experimental: 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.
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10 Meter Walk Test
Time Frame: 24 hours postoperatively following total knee arthroplasty
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Consumption
Time Frame: PACU Discharge through 24 hours postoperatively
|
Opioid Requirements will be retrieved from the patient's electronic medical record
|
PACU Discharge through 24 hours postoperatively
|
|
Pain With Activity at 24 Hours
Time Frame: 24 Hours Following Surgery
|
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.
|
24 Hours Following Surgery
|
|
Percentage Change in Knee Extension Strength From Baseline
Time Frame: 24 Hours Following Surgery
|
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
Time Frame: Perioperative through 48 hours postoperatively
|
Need for antiemetic therapy will be assessed through evaluation of the electronic medical record.
|
Perioperative through 48 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-1419
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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