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The objective of the study is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty. This randomized clinical trial will compare outcomes between adductor canal blocks, periarticular bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this study will help determine the most appropriate perioperative pain management strategy for patients undergoing a total knee arthroplasty.
Over 600,000 total knee arthroplasties (TKAs) are performed each year in the United States, with expectations for greater than 4 million/year by the year 2030. Since the onset of TKAs in the 1960's, there have been developments that have improved both functionality and patient satisfaction. In the last decade, a focus has been made on multimodal pain management protocols, more rapid functional recovery, reduced length of hospital stay, and minimizing side effects of treatment while maintaining function and durability. The widespread use of regional anesthesia has led to improvements in pain control, more rapid functional recovery, and reduced length of stay. In recent years many surgeons have transitioned from femoral nerve blocks (proximal femoral nerve) to adductor canal blocks (distal femoral nerve) to maintain a sensory block for pain control, while minimizing any motor blockade that is typically seen in proximal femoral nerve blocks, which would hamper rehabilitation, and increase risk of falls. In addition to regional blocks, which are typically performed in the preoperative setting, some surgeons favor an intraoperative periarticular anesthetic injection (PAI), typically with bupivacaine or the long acting form liposomal bupivacaine, either in conjunction with an adductor canal block, or independently. In theory, PAI has the advantage of a comparable sensory nerve block as an adductor canal block, without the disadvantages and risks, which include prolonged quadriceps weakness, fall risk, and neurologic dysfunction.
The purpose of this randomized control trial is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor Canal Block | Active Comparator | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) |
|
| Periarticular SB | Active Comparator | 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. |
|
| ACB + SB | Active Comparator | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in VAS Pain Scores | Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain" | Day 0 through Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activity Level | Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited. | Day 0 and Day 1 |
| Opioid Consumption | Total amount of opioid consumption post-operatively will be recorded. The less opioids consumed (mg) postoperatively the better. A morphine equivalence metric will be used for equianalgesic comparison. Minimum is 0 mg, maximum is unlimited. |
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Inclusion Criteria:
- Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.
Exclusion Criteria:
- Allergy to bupivicaine or liposomal bupivicaine.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Geller, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23011713 | Background | Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012 Sep 26;308(12):1227-36. doi: 10.1001/2012.jama.11153. | |
| 25381400 | Background | Berend ME, Berend KR, Lombardi AV Jr. Advances in pain management: game changers in knee arthroplasty. Bone Joint J. 2014 Nov;96-B(11 Supple A):7-9. doi: 10.1302/0301-620X.96B11.34514. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adductor Canal Block | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection |
| FG001 | Periarticular SB | 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection |
| FG002 | ACB + SB | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adductor Canal Block | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in VAS Pain Scores | Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain" | Posted | Mean | Standard Deviation | scores on a scale | Day 0 through Day 3 |
|
postoperative day 0 through post-operative day 21.
No serious adverse events, including mortality. This was a healthy cohort of patients undergoing elective surgery for total knee replacement. There were no expected adverse events.
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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 | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Grosso | Columbia University Medical Center | 2123058193 | mgrosso13@gmail.com |
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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 1, 2016 | Feb 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Day 0 through Day 3 |
| Range of Knee Flexion | Range of knee flexion for active motion will be recorded at 3 week follow-up for all groups. The greater range of motion the better, with a good outcome considered at least 115 degrees of motion. | Postoperative day 21 |
| Length of Hospital Stay | Total length of hospital stay from time of surgery through time of discharge will be recorded. The shorter the length of stay (days) the better. Range 0 days to 5 days. | Up to Day 5 |
| 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. |
| 25376972 | Background | Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169. |
| 25735501 | Background | Wang C, Cai XZ, Yan SG. Comparison of Periarticular Multimodal Drug Injection and Femoral Nerve Block for Postoperative Pain Management in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2015 Jul;30(7):1281-6. doi: 10.1016/j.arth.2015.02.005. Epub 2015 Feb 20. |
| 26117072 | Background | Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3. |
| Background | Berry J. Audience response-practice norm/trends. 22nd Annual Meeting of the American Association of Hip and Knee Surgeons. American Association of Hip and Knee Surgeons. November 2012. |
| Periarticular SB |
20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection |
| BG002 | ACB + SB | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| OG002 | ACB + SB | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection |
|
|
| Secondary | Change in Activity Level | Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited. | Posted | Mean | Standard Deviation | steps | Day 0 and Day 1 |
|
|
|
| Secondary | Opioid Consumption | Total amount of opioid consumption post-operatively will be recorded. The less opioids consumed (mg) postoperatively the better. A morphine equivalence metric will be used for equianalgesic comparison. Minimum is 0 mg, maximum is unlimited. | Posted | Mean | Standard Deviation | morphine equivalents | Day 0 through Day 3 |
|
|
|
| Secondary | Range of Knee Flexion | Range of knee flexion for active motion will be recorded at 3 week follow-up for all groups. The greater range of motion the better, with a good outcome considered at least 115 degrees of motion. | Posted | Mean | Standard Deviation | degrees | Postoperative day 21 |
|
|
|
| Secondary | Length of Hospital Stay | Total length of hospital stay from time of surgery through time of discharge will be recorded. The shorter the length of stay (days) the better. Range 0 days to 5 days. | Posted | Mean | Standard Deviation | days | Up to Day 5 |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Periarticular SB | 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | ACB + SB | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection | 0 | 51 | 0 | 51 | 0 | 51 |
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| D000588 |
| Amines |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| POD1 |
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| POD2 |
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| POD3 |
|