Trial Outcomes & Findings for Continuous Adductor Canal Blocks Vs. Low Dose Femoral Nerve Blocks For Early Rehabilitation After Total Knee Arthroplasty (NCT NCT02453321)
NCT ID: NCT02453321
Last Updated: 2018-03-27
Results Overview
Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay, an average of 4 days
Results posted on
2018-03-27
Participant Flow
Patients presenting for Total Knee Arthroplasty (TKA) at University of Pittsburgh Medical Center (UPMC) - Passavant Hospital were approached on the day of surgery, but some were called the day prior to surgery.
No patients were enrolled but excluded prior to assignment to a randomized group.
Participant milestones
| Measure |
Cont. Femoral Block - Low Dose Group
Continuous Femoral Block - Low Dose Intervention Group. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of Postoperative Day (POD) #2.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupi
|
Cont. Femoral Block - Higher Dose
Place the Continuous Peripheral Nerve Block (CPNB) in same manner as low-dose group, with increased rate of 4ml/hr. Hypothesis is that this group may experience better pain control, but more motor blockade of thigh and less participation in physical therapy is likely.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform blockade of the sensory components of the femoral nerve to decrease pain in the knee after TKA.
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cont. Femoral Block - Low Dose Group
Continuous Femoral Block - Low Dose Intervention Group. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of Postoperative Day (POD) #2.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupi
|
Cont. Femoral Block - Higher Dose
Place the Continuous Peripheral Nerve Block (CPNB) in same manner as low-dose group, with increased rate of 4ml/hr. Hypothesis is that this group may experience better pain control, but more motor blockade of thigh and less participation in physical therapy is likely.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform blockade of the sensory components of the femoral nerve to decrease pain in the knee after TKA.
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis: This group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
|---|---|---|---|
|
Overall Study
Weakness
|
1
|
1
|
2
|
|
Overall Study
Deep Venous Thrombosis
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cont. Femoral Block - Low Dose Group
n=20 Participants
Arm is named by the intervention received... Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease intended to block the sensory nerves to decrease pain in the knee after TKA.
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It is only dosed postoperatively after verifying sciatic nerve function is intact. The infusion is 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the infusions of bupivacaine in peripheral nerve catheters will be 0.0625% for the femoral and adductor canal, and
|
Cont. Femoral Block - Higher Dose
n=21 Participants
Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
Continuous Femoral Nerve Block: A 27g plastic catheter inserted below the inguinal crease to cause conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
n=21 Participants
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero-medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=21 Participants
|
24 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=20 Participants
|
13 Participants
n=21 Participants
|
13 Participants
n=21 Participants
|
38 Participants
n=62 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 5.5 • n=20 Participants
|
67.0 years
STANDARD_DEVIATION 5.1 • n=21 Participants
|
66.5 years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
66.2 years
STANDARD_DEVIATION 5.8 • n=62 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
15 Participants
n=21 Participants
|
8 Participants
n=21 Participants
|
33 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
6 Participants
n=21 Participants
|
13 Participants
n=21 Participants
|
29 Participants
n=62 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
21 participants
n=21 Participants
|
21 participants
n=21 Participants
|
62 participants
n=62 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an average of 4 daysAbility to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.
Outcome measures
| Measure |
Cont. Femoral Block - Low Dose Group
n=19 Participants
Arm is named by the intervention received.. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupi
|
Cont. Femoral Block - Higher Dose
n=19 Participants
Place the CPNB in same manner as low-dose group, but rate to be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
n=19 Participants
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero- medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
|---|---|---|---|
|
Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}
|
67.3 Hours
Interval 38.9 to 70.1
|
66 Hours
Interval 44.8 to 70.3
|
46.5 Hours
Interval 40.5 to 68.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded.If pain is controlled and rehabilitation activity is optimal patient may be discharged at an earlier time
Outcome measures
| Measure |
Cont. Femoral Block - Low Dose Group
n=19 Participants
Arm is named by the intervention received.. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupi
|
Cont. Femoral Block - Higher Dose
n=19 Participants
Place the CPNB in same manner as low-dose group, but rate to be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
n=19 Participants
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero- medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
|---|---|---|---|
|
Average Length of Stay (to be Reported in Hours After Surgery)
|
75.5 Hours
Interval 73.0 to 95.3
|
74.3 Hours
Interval 70.3 to 80.8
|
72.5 Hours
Interval 51.5 to 75.3
|
SECONDARY outcome
Timeframe: postoperative day oneThe outcome is measured using a Numeric pain scale. The patient reports their average pain felt on postoperative day one, on a scale of 0 to 10 inclusive. Zero in this case indicates no pain at all and 10 indicates the worst pain they have ever felt.
Outcome measures
| Measure |
Cont. Femoral Block - Low Dose Group
n=19 Participants
Arm is named by the intervention received.. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupi
|
Cont. Femoral Block - Higher Dose
n=19 Participants
Place the CPNB in same manner as low-dose group, but rate to be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
n=19 Participants
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero- medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
|---|---|---|---|
|
Postoperative Pain, Average Reported Score 11-point Scale
|
3.961 units on scale
Standard Deviation 1.517
|
4.116 units on scale
Standard Deviation 1.638
|
4.282 units on scale
Standard Deviation 1.722
|
SECONDARY outcome
Timeframe: Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atemptSustained Straight Leg Raise is the ability to elevate the heel and leg/knee off of bed for 5 seconds postoperatively after spinal anesthetic has resolved contralaterally.
Outcome measures
| Measure |
Cont. Femoral Block - Low Dose Group
n=19 Participants
Arm is named by the intervention received.. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupi
|
Cont. Femoral Block - Higher Dose
n=19 Participants
Place the CPNB in same manner as low-dose group, but rate to be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
Continuous Femoral Nerve Block: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
n=19 Participants
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the antero- medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
|---|---|---|---|
|
Sustained Straight Leg Raise
Yes
|
19 Participants
|
14 Participants
|
16 Participants
|
|
Sustained Straight Leg Raise
No
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Sustained Straight Leg Raise
N/A
|
0 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
Cont. Femoral Block - Low Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cont. Femoral Block - Higher Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Continuous Adductor Canal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cont. Femoral Block - Low Dose Group
n=20 participants at risk
Continuous Femoral Nerve Block (CFNB) -Low dose. The Block/catheter is placed about 5cm below groin usually corresponding with the ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
CFNB: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine is 0.0625%
|
Cont. Femoral Block - Higher Dose
n=21 participants at risk
CFNB placed in same manner as low-dose group, but rate will be higher (4ml/hr). Hypothesis is this group may experience better pain control, but likely will have more motor blockade of thigh and less participation in physical therapy.
CFNB: A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: The concentration of the continuous infusion of bupivacaine tho
|
Continuous Adductor Canal
n=21 participants at risk
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
Nerve Block, Continuous Adductor Canal: A 27g plastic catheter placed on the anterior-medial thigh midway between the Anterior Superior Iliac Spine (ASIS) and patella. Intent is to block sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty.
Continuous Sciatic Nerve Block: A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
Bupivacaine: T
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Deep Vien Thrombosis
|
0.00%
0/20 • From enrollment on the day of surgery until discharge from the hospital, on average 3 days.
|
4.8%
1/21 • Number of events 1 • From enrollment on the day of surgery until discharge from the hospital, on average 3 days.
|
0.00%
0/21 • From enrollment on the day of surgery until discharge from the hospital, on average 3 days.
|
Additional Information
Kevin King, DO - Clinical Asst. Professor
University of Pittsburgh Medical Center
Phone: 412 748-5589
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place