A Phase 4 interventional study of Bupivacaine in Osteoarthritis, sponsored by Columbia University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 155 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
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Exclusion Criteria:
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)
Drug: Bupivacaine
50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Drug: Bupivacaine
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.
Drug: Bupivacaine
15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Also known as: Bupivacaine Hydrochloride, Marcaine
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"
Time frame: Day 0 through Day 3
Change in Activity Level
Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 5
| Milestone | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Started | 53 | 51 | 51 |
| Completed | 53 | 51 | 51 |
| Not completed | 0 | 0 | 0 |
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"
| scores on a scale | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Day 0 | 3.0 ± 2.9 | 3.0 ± 3.0 | 2.7 ± 2.6 |
| Day 1 | 3.9 ± 2.3 | 3.8 ± 2.4 | 3.0 ± 2.1 |
| Day 2 | 4.1 ± 2.5 | 3.8 ± 2.4 | 3.3 ± 2.5 |
| Day 3 | 4.2 ± 3.1 | 3.0 ± 2.8 | 2.0 ± 2.0 |
Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited.
| steps | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Day 0 | 26 ± 33 | 68 ± 63 | 65 ± 50 |
| Day 1 | 124 ± 117 | 120 ± 117 | 139 ± 118 |
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.
| morphine equivalents | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Combined (POD0 through POD3) | 131 ± 74 | 100 ± 62 | 98 ± 62 |
| POD0 | 33 ± 15 | 31 ± 18 | 35 ± 21 |
| POD1 | 48 ± 25 | 42 ± 31 | 40 ± 30 |
| POD2 | 35 ± 29 | 20 ± 22 | 18 ± 21 |
| POD3 | 13 ± 23 | 5.5 ± 16 | 4.3 ± 9 |
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.
| degrees | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Range of Knee Flexion | 99 ± 15 | 104 ± 12 | 101 ± 16 |
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.
| days | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Length of Hospital Stay | 2.9 ± 1.5 | 2.5 ± 1.2 | 2.5 ± 2.1 |
Collected over postoperative day 0 through post-operative day 21.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adductor Canal Block | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Periarticular SB | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| ACB + SB | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | Adductor Canal Block | Periarticular SB | ACB + SB | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 9 | 13 | 36 |
| >=65 years | 39 | 42 | 38 | 119 |
| Age, Continuous(years) | Adductor Canal Block | Periarticular SB | ACB + SB | Total |
|---|---|---|---|---|
| Mean | 69 ± 10 | 73 ± 10 | 71 ± 10 | 71 ± 10 |
| Sex: Female, Male(Participants) | Adductor Canal Block | Periarticular SB | ACB + SB | Total |
|---|---|---|---|---|
| Female | 38 | 33 | 37 | 108 |
| Male | 15 | 18 | 14 | 47 |
| Race and Ethnicity Not Collected(Participants) | Adductor Canal Block | Periarticular SB | ACB + SB | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
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