Osteoarthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBupivacaine
15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS Pain Scores | Day 0 through Day 3 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Up to Day 5 | 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. |
| Change in Activity Level | Day 0 and Day 1 | Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited. |
| Opioid Consumption | Day 0 through Day 3 | 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. |
| Range of Knee Flexion | Postoperative day 21 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| 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 | 51 |
| 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 | 51 |
| Total | 155 |
Baseline characteristics
| Characteristic | Adductor Canal Block | Periarticular SB | ACB + SB | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 42 Participants | 38 Participants | 119 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 9 Participants | 13 Participants | 36 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 10 | 73 years STANDARD_DEVIATION 10 | 71 years STANDARD_DEVIATION 10 | 71 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 33 Participants | 37 Participants | 108 Participants |
| Sex: Female, Male Male | 15 Participants | 18 Participants | 14 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 0 / 53 | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 53 | 0 / 51 | 0 / 51 |
Outcome results
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
Time frame: Day 0 through Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block | Change in VAS Pain Scores | Day 0 | 3.0 scores on a scale | Standard Deviation 2.9 |
| Adductor Canal Block | Change in VAS Pain Scores | Day 2 | 4.1 scores on a scale | Standard Deviation 2.5 |
| Adductor Canal Block | Change in VAS Pain Scores | Day 3 | 4.2 scores on a scale | Standard Deviation 3.1 |
| Adductor Canal Block | Change in VAS Pain Scores | Day 1 | 3.9 scores on a scale | Standard Deviation 2.3 |
| Periarticular SB | Change in VAS Pain Scores | Day 0 | 3.0 scores on a scale | Standard Deviation 3 |
| Periarticular SB | Change in VAS Pain Scores | Day 1 | 3.8 scores on a scale | Standard Deviation 2.4 |
| Periarticular SB | Change in VAS Pain Scores | Day 2 | 3.8 scores on a scale | Standard Deviation 2.4 |
| Periarticular SB | Change in VAS Pain Scores | Day 3 | 3.0 scores on a scale | Standard Deviation 2.8 |
| ACB + SB | Change in VAS Pain Scores | Day 2 | 3.3 scores on a scale | Standard Deviation 2.5 |
| ACB + SB | Change in VAS Pain Scores | Day 0 | 2.7 scores on a scale | Standard Deviation 2.6 |
| ACB + SB | Change in VAS Pain Scores | Day 1 | 3.0 scores on a scale | Standard Deviation 2.1 |
| ACB + SB | Change in VAS Pain Scores | Day 3 | 2.0 scores on a scale | Standard Deviation 2 |
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.
Time frame: Day 0 and Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block | Change in Activity Level | Day 0 | 26 steps | Standard Deviation 33 |
| Adductor Canal Block | Change in Activity Level | Day 1 | 124 steps | Standard Deviation 117 |
| Periarticular SB | Change in Activity Level | Day 0 | 68 steps | Standard Deviation 63 |
| Periarticular SB | Change in Activity Level | Day 1 | 120 steps | Standard Deviation 117 |
| ACB + SB | Change in Activity Level | Day 0 | 65 steps | Standard Deviation 50 |
| ACB + SB | Change in Activity Level | Day 1 | 139 steps | Standard Deviation 118 |
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.
Time frame: Up to Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adductor Canal Block | Length of Hospital Stay | 2.9 days | Standard Deviation 1.5 |
| Periarticular SB | Length of Hospital Stay | 2.5 days | Standard Deviation 1.2 |
| ACB + SB | Length of Hospital Stay | 2.5 days | Standard Deviation 2.1 |
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.
Time frame: Day 0 through Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block | Opioid Consumption | Combined (POD0 through POD3) | 131 morphine equivalents | Standard Deviation 74 |
| Adductor Canal Block | Opioid Consumption | POD2 | 35 morphine equivalents | Standard Deviation 29 |
| Adductor Canal Block | Opioid Consumption | POD1 | 48 morphine equivalents | Standard Deviation 25 |
| Adductor Canal Block | Opioid Consumption | POD3 | 13 morphine equivalents | Standard Deviation 23 |
| Adductor Canal Block | Opioid Consumption | POD0 | 33 morphine equivalents | Standard Deviation 15 |
| Periarticular SB | Opioid Consumption | POD2 | 20 morphine equivalents | Standard Deviation 22 |
| Periarticular SB | Opioid Consumption | Combined (POD0 through POD3) | 100 morphine equivalents | Standard Deviation 62 |
| Periarticular SB | Opioid Consumption | POD0 | 31 morphine equivalents | Standard Deviation 18 |
| Periarticular SB | Opioid Consumption | POD1 | 42 morphine equivalents | Standard Deviation 31 |
| Periarticular SB | Opioid Consumption | POD3 | 5.5 morphine equivalents | Standard Deviation 16 |
| ACB + SB | Opioid Consumption | POD0 | 35 morphine equivalents | Standard Deviation 21 |
| ACB + SB | Opioid Consumption | POD2 | 18 morphine equivalents | Standard Deviation 21 |
| ACB + SB | Opioid Consumption | Combined (POD0 through POD3) | 98 morphine equivalents | Standard Deviation 62 |
| ACB + SB | Opioid Consumption | POD3 | 4.3 morphine equivalents | Standard Deviation 9 |
| ACB + SB | Opioid Consumption | POD1 | 40 morphine equivalents | Standard Deviation 30 |
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.
Time frame: Postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adductor Canal Block | Range of Knee Flexion | 99 degrees | Standard Deviation 15 |
| Periarticular SB | Range of Knee Flexion | 104 degrees | Standard Deviation 12 |
| ACB + SB | Range of Knee Flexion | 101 degrees | Standard Deviation 16 |