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This study will evaluate the affects of a single injection ultrasound-guided adductor canal block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia provided by the adductor canal block with that provided by single injection lumbar plexus blockade. The working hypothesis is that the analgesia provided by the adductor canal block will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome will be a comparison of verbal numerical pain scores at rest and with movement over the first 24 hours following nerve blockade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor canal block | Experimental | Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty. |
|
| Lumbar plexus block | Active Comparator | Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adductor canal block | Drug |
|
| |
| Lumbar plexus block |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Pain Scores at 6 Hours Post Nerve Blockade. | Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes. | 6 hours post block. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block. | 6, 12, 18, and 24 hours |
| Time to First Analgesic | Time to first analgesic between two groups: adductor canal block and lumbar plexus block. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daryl S Henshaw, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15062705 | Background | Meek RM, Masri BA, Duncan CP. Minimally invasive unicompartmental knee replacement: rationale and correct indications. Orthop Clin North Am. 2004 Apr;35(2):191-200. doi: 10.1016/S0030-5898(03)00115-9. | |
| 18358380 | Background | Riddle DL, Jiranek WA, McGlynn FJ. Yearly incidence of unicompartmental knee arthroplasty in the United States. J Arthroplasty. 2008 Apr;23(3):408-12. doi: 10.1016/j.arth.2007.04.012. Epub 2007 Nov 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adductor Canal Block | Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty. Adductor canal block |
| FG001 | Lumbar Plexus Block | Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty. Lumbar plexus block |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adductor Canal Block | Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty. Adductor canal block |
| BG001 | Lumbar Plexus Block |
| 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 | Verbal Pain Scores at 6 Hours Post Nerve Blockade. | Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | 6 hours post block. |
|
24 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 | Adductor Canal Block | Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty. Adductor canal block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daryl Henshaw | Wake Forest University Health Sciences | 3367166344 | dhenshaw@wakehealth.edu |
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| Drug |
|
| 24 hours |
| Opioid Related Side Effects | Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block. | 6, 12, 18, and 24 hours |
| Quadriceps Motor Strength | Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes. | 6 hours |
| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. |
| 18915634 | Background | GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available. |
| 19901788 | Background | Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available. |
| 8156678 | Background | Horner G, Dellon AL. Innervation of the human knee joint and implications for surgery. Clin Orthop Relat Res. 1994 Apr;(301):221-6. |
| 22221014 | Background | Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4. |
| 21039357 | Background | Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29. |
| 12727037 | Background | Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3. |
| 3450848 | Background | Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419. |
| Withdrawn for failure to place block |
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Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Opioid Consumption | Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block. | Posted | Mean | Standard Deviation | mg | 6, 12, 18, and 24 hours |
|
|
|
| Secondary | Time to First Analgesic | Time to first analgesic between two groups: adductor canal block and lumbar plexus block. | Posted | Mean | Standard Deviation | minutes | 24 hours |
|
|
|
| Secondary | Opioid Related Side Effects | Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block. | Posted | Number | events | 6, 12, 18, and 24 hours |
|
|
|
| Secondary | Quadriceps Motor Strength | Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes. | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 38 |
| 74 |
| EG001 | Lumbar Plexus Block | Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty. Lumbar plexus block | 0 | 73 | 0 | 73 | 43 | 73 |
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| 18 hours |
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| 24 hours |
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| Nausea 18 hours |
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| Nausea 24 hours |
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| Vomiting 6 hours |
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| Vomiting 12 hours |
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| Vomiting 18 hours |
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| Vomiting 24 hours |
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| Pruritus 6 hours |
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| Pruritus 12 hours |
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| Pruritus 18 hours |
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| Pruritus 24 hours |
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