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| ID | Type | Description | Link |
|---|---|---|---|
| UCIANES06 | Other Identifier | UCIANE |
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The purpose of the study is to determine the effect of a single injection adductor canal block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).
Total knee arthroplasty (TKA), also known as total knee replacement, has been associated with a significant pain burden in the postoperative period. Methods to manage pain associated with this operation have in the past included injecting pain medication into the epidural space of the spinal cord, around a peripheral nerve, around the space surrounding the joint, or a combination of pain management techniques.
In recent years, the femoral nerve block (injection of pain medication around the peripheral nerve, specifically the femoral nerve) has been proposed as an effective way to manage pain while sparing many of the undesirable side effects of narcotic pain medications. Traditional techniques of the femoral nerve block involve the injection of pain medication around the peripheral nerve at the level of the groin area. A nerve block at this point in the path of the femoral nerve affects all of the musculature of the front part of the thigh as well as the nerves responsible for sensation to the majority of the knee joint. The femoral nerve block performed at the level of the groin provides an excellent level of pain relief at the knee joint, but is also associated with weakness of the quadriceps muscle. The resultant quadriceps weakness can both slow the physical therapy process and be a risk factor for post-operative falls. Participation in physical therapy is a critical component of the rehabilitation process and is started as soon as tolerated by the patient. The ideal pain management technique would provide the same degree of pain relief as the femoral nerve block while preserving the strength in the front part of the thigh muscles.
One suggested technique to achieve both of these goals is the injection of a large volume dilute local pain medication mixture around the joint during surgery. This has been used as a substitute to provide pain relief around the joint while maintaining strength in the quadriceps muscle and the ability to participate in physical therapy. This technique however, does not last long since the medication disperses away from the joint space.
A variation of the femoral nerve block in the lower thigh, within a space called the adductor canal, has been demonstrated to provide equivalent amounts of pain relief as a proximal femoral nerve block along with preservation of motor function to the quadriceps muscle. What is not as well-established is whether the combination of injecting pain medication directly around the joint space in the knee along with a single injection of pain medication in the adductor canal in the lower thigh can improve pain scores and extend the duration of pain relief provided compared to only an injection around the joint space.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACB Control + Local Infiltration | Experimental | ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline |
|
| ACB Study + Local infiltration | Experimental | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline |
|
| ACB Study Only | Experimental | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACB Control - 20 ml saline injection for ACB | Other | Adductor Canal Block Control (20 ml saline injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain. | within 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | 24 Hour post-surgical opioid use | within 24 hours postoperative |
| Ambulation Distance | Total distance ambulated during physical therapy during first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Anxiety | Self-reported subject anxiety prior to surgery | pre-operative day of surgery |
| Baseline Pain Score | Baseline pain preoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Rinehart, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21388906 | Background | Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8. | |
| 23891055 | Background | Robbins SM, Rastogi R, McLaughlin TL. Predicting acute recovery of physical function following total knee joint arthroplasty. J Arthroplasty. 2014 Feb;29(2):299-303. doi: 10.1016/j.arth.2013.06.033. Epub 2013 Jul 26. |
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Subjects were recruited from the main operating room from January 2015 through December of 2019. Recruitment was prolonged due to PI changes secondary to personnel leaving the university.
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| ID | Title | Description |
|---|---|---|
| FG000 | Joint Infiltration Only | ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 19, 2024 |
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| ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block | Drug | Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
|
| Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline | Drug | 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL) |
|
| First 24 hours post-operative |
| Preoperatively day of surgery |
| NRS Pain Rating | A modified pain score similar to VAS but rated from 0-10 | Preop, PACU, and 4,8, 12, and 24 hours post-operatively. |
| 16698416 | Background | Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. |
| 19606021 | Background | Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a. |
| 20966667 | Background | Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18. |
| 19553071 | Background | Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24. |
| 24121608 | Background | Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015. |
| 23897505 | Background | Mudumbai SC, Kim TE, Howard SK, Workman JJ, Giori N, Woolson S, Ganaway T, King R, Mariano ER. Continuous adductor canal blocks are superior to continuous femoral nerve blocks in promoting early ambulation after TKA. Clin Orthop Relat Res. 2014 May;472(5):1377-83. doi: 10.1007/s11999-013-3197-y. |
| 22325963 | Background | Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: a prospective, crossover, randomized clinical trial. J Arthroplasty. 2012 Jun;27(6):1234-8. doi: 10.1016/j.arth.2011.12.021. Epub 2012 Feb 8. |
| 23783531 | Background | Teng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20. |
| FG001 | ACB + Joint Infiltration | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL) |
| FG002 | ACB Only | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ACB Control + Local Infiltration | ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL) |
| BG001 | ACB Study + Local Infiltration | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL) |
| BG002 | ACB Study Only | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height (cm) | Median | Inter-Quartile Range | centimeters |
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| Weight (lbs) | Median | Inter-Quartile Range | pounds |
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| 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 | Pain Score | The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain. | Posted | Median | Inter-Quartile Range | units on a scale | within 24 hours postoperative |
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| Secondary | Opioid Use | 24 Hour post-surgical opioid use | Posted | Median | Inter-Quartile Range | Daily mg morphine equivalents | within 24 hours postoperative |
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| Secondary | Ambulation Distance | Total distance ambulated during physical therapy during first 24 hours | Posted | Median | Inter-Quartile Range | feet | First 24 hours post-operative |
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| Other Pre-specified | Baseline Anxiety | Self-reported subject anxiety prior to surgery | Data was incompletely collected across the study so no analysis performed | Posted | pre-operative day of surgery |
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| Other Pre-specified | Baseline Pain Score | Baseline pain preoperatively | Study data was incompletely collected across the study period so no analysis was performed | Posted | Preoperatively day of surgery |
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| Other Pre-specified | NRS Pain Rating | A modified pain score similar to VAS but rated from 0-10 | NRS scores were not collected during the study, so no analysis is performed. | Posted | Preop, PACU, and 4,8, 12, and 24 hours post-operatively. |
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All subjects were followed to 30 days post-operatively
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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 | Joint Infiltration Only | ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL) | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | ACB + Joint Infiltration | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL) | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | ACB Only | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) | 0 | 20 | 0 | 20 | 0 | 20 |
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The PI changed twice during the study period, and the final PI left after the beginning of the COVID-19 pandemic. We have endeavored to collect as much of the original study data as possible in order to close out this record, but many measures were not collected (baseline anxiety & pain, NRS scores, etc). We have reported as much as possible based on hospital records and existing data that was collected during the study period.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Rinehart | UC Irvine Health Department of Anesthesiology & Perioperative Care | 714-456-7415 | jrinehar@hs.uci.edu |
| Aug 23, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D020910 | Ketorolac |
| D003000 | Clonidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| OG002 |
| ACB Only |
ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
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| OG002 | ACB Only | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
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| OG002 | ACB Only | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
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| OG002 | ACB Only | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
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| OG002 | ACB Only | ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine) |
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