Trial Outcomes & Findings for Femoral Triangle and Adductor Canal Blocks Versus Femoral Nerve Block for Total Knee Arthroplasty (NCT NCT03645954)
NCT ID: NCT03645954
Last Updated: 2021-02-03
Results Overview
The extent of postoperative motor blockade will be evaluated using Bromage scale: Grade I - free movement of legs and feet, Grade II - just able to flex knees with free movement of feet, Grade III - unable to flex knees, but with free movement of feet, Grade IV - unable to move legs or feet. It will be assessed at 3, 6, 24, 48 hours after surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
3, 6, 24, 48 hours after primary total knee arthroplasty.
Results posted on
2021-02-03
Participant Flow
Participant milestones
| Measure |
Femoral Nerve Block
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
37
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Femoral Nerve Block
n=37 Participants
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
n=40 Participants
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 9.3 • n=37 Participants
|
68.5 years
STANDARD_DEVIATION 9.8 • n=40 Participants
|
68.8 years
STANDARD_DEVIATION 9.5 • n=77 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=37 Participants
|
11 Participants
n=40 Participants
|
35 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
29 Participants
n=40 Participants
|
42 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
31.9 kg/m^2
STANDARD_DEVIATION 5.5 • n=37 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=40 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 5.6 • n=77 Participants
|
|
Physical Status According to ASA
ASA status: I
|
2 Participants
n=37 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=77 Participants
|
|
Physical Status According to ASA
ASA status: II
|
33 Participants
n=37 Participants
|
36 Participants
n=40 Participants
|
69 Participants
n=77 Participants
|
|
Physical Status According to ASA
ASA status III
|
2 Participants
n=37 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=77 Participants
|
PRIMARY outcome
Timeframe: 3, 6, 24, 48 hours after primary total knee arthroplasty.The extent of postoperative motor blockade will be evaluated using Bromage scale: Grade I - free movement of legs and feet, Grade II - just able to flex knees with free movement of feet, Grade III - unable to flex knees, but with free movement of feet, Grade IV - unable to move legs or feet. It will be assessed at 3, 6, 24, 48 hours after surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=37 Participants
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
n=40 Participants
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
|---|---|---|
|
Extent of Motor Blockade
3 hours after TKA · Bromage Grade I
|
18 Participants
|
29 Participants
|
|
Extent of Motor Blockade
3 hours after TKA · Bromage Grade II
|
13 Participants
|
5 Participants
|
|
Extent of Motor Blockade
3 hours after TKA · Bromage Grade III
|
1 Participants
|
1 Participants
|
|
Extent of Motor Blockade
3 hours after TKA · Bromage Grade IV
|
5 Participants
|
5 Participants
|
|
Extent of Motor Blockade
6 hours after TKA · Bromage Grade I
|
25 Participants
|
38 Participants
|
|
Extent of Motor Blockade
6 hours after TKA · Bromage Grade II
|
12 Participants
|
2 Participants
|
|
Extent of Motor Blockade
6 hours after TKA · Bromage Grade III
|
0 Participants
|
0 Participants
|
|
Extent of Motor Blockade
6 hours after TKA · Bromage Grade IV
|
0 Participants
|
0 Participants
|
|
Extent of Motor Blockade
24 hours after TKA · Bromage Grade I
|
31 Participants
|
35 Participants
|
|
Extent of Motor Blockade
24 hours after TKA · Bromage Grade II
|
6 Participants
|
5 Participants
|
|
Extent of Motor Blockade
24 hours after TKA · Bromage Grade III
|
0 Participants
|
0 Participants
|
|
Extent of Motor Blockade
24 hours after TKA · Bromage Grade IV
|
0 Participants
|
0 Participants
|
|
Extent of Motor Blockade
48 hours after TKA · Bromage Grade I
|
29 Participants
|
34 Participants
|
|
Extent of Motor Blockade
48 hours after TKA · Bromage Grade II
|
8 Participants
|
6 Participants
|
|
Extent of Motor Blockade
48 hours after TKA · Bromage Grade III
|
0 Participants
|
0 Participants
|
|
Extent of Motor Blockade
48 hours after TKA · Bromage Grade IV
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3, 6, 24, 48 hours after primary total knee arthroplasty.Postoperative pain intensity and pain control will be assessed in both groups using visual analogue scale (VAS). VAS scale is consisted of a scale from 0 (no pain) to 10 (worst imaginable pain). Pain control and pain intensity will be assessed at rest, during active and passive 45 degree knee flexion at 3, 6, 24, 48 hours after surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=37 Participants
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
n=40 Participants
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
|---|---|---|
|
Postoperative Pain Intensity and Pain Control
3 hours after TKA (at rest)
|
1.22 score on a scale
Standard Deviation 2.04
|
0.45 score on a scale
Standard Deviation 1.11
|
|
Postoperative Pain Intensity and Pain Control
6 hours after TKA (at rest)
|
1.27 score on a scale
Standard Deviation 1.97
|
1.45 score on a scale
Standard Deviation 2.06
|
|
Postoperative Pain Intensity and Pain Control
24 hours after TKA (at rest)
|
2.00 score on a scale
Standard Deviation 2.24
|
2.10 score on a scale
Standard Deviation 2.13
|
|
Postoperative Pain Intensity and Pain Control
48 hours after TKA (at rest)
|
1.78 score on a scale
Standard Deviation 2.45
|
1.63 score on a scale
Standard Deviation 1.81
|
|
Postoperative Pain Intensity and Pain Control
3 hours after TKA (passive 45-degree knee flexion)
|
2.14 score on a scale
Standard Deviation 2.76
|
1.10 score on a scale
Standard Deviation 1.89
|
|
Postoperative Pain Intensity and Pain Control
6 hours after TKA (passive 45-degree knee flexion)
|
2.27 score on a scale
Standard Deviation 2.32
|
2.55 score on a scale
Standard Deviation 2.40
|
|
Postoperative Pain Intensity and Pain Control
24 hours after TKA (passive 45-degree knee flexion)
|
4.41 score on a scale
Standard Deviation 2.39
|
3.73 score on a scale
Standard Deviation 2.24
|
|
Postoperative Pain Intensity and Pain Control
48 hours after TKA (passive 45-degree knee flexion)
|
4.19 score on a scale
Standard Deviation 2.61
|
3.40 score on a scale
Standard Deviation 2.01
|
|
Postoperative Pain Intensity and Pain Control
3 hours after TKA (active 45-degree knee flexion)
|
2.19 score on a scale
Standard Deviation 2.81
|
1.20 score on a scale
Standard Deviation 1.93
|
|
Postoperative Pain Intensity and Pain Control
6 hours after TKA (active 45-degree knee flexion)
|
2.35 score on a scale
Standard Deviation 2.40
|
2.63 score on a scale
Standard Deviation 2.53
|
|
Postoperative Pain Intensity and Pain Control
24 hours after TKA (active 45-degree knee flexion)
|
5.00 score on a scale
Standard Deviation 2.63
|
4.33 score on a scale
Standard Deviation 2.43
|
|
Postoperative Pain Intensity and Pain Control
48 hours after TKA (active 45-degree knee flexion)
|
4.54 score on a scale
Standard Deviation 2.65
|
3.95 score on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: 24, 48 hours after primary total knee arthroplasty.Postoperative ability of early ambulation will be assessed using Timed Up and Go (TUG) test. The TUG test measures the time it takes the patient to get up from a bed, walk 3 meters, turn, walk back to the bed and sit down. The TUG test results will be evaluated at 24 and 48 hours after surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=37 Participants
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
n=40 Participants
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
|---|---|---|
|
Ability of Early Ambulation After Surgery
24 hours after TKA
|
53.6 seconds
Standard Deviation 54.8
|
53.7 seconds
Standard Deviation 23.0
|
|
Ability of Early Ambulation After Surgery
48 hours after TKA
|
47.3 seconds
Standard Deviation 47.1
|
36.9 seconds
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 3, 6, 24, 48 hours after primary total knee arthroplasty.The need of additional opioids will be recorded at 3, 6, 24 and 48 hours after surgery in both groups.
Outcome measures
| Measure |
Femoral Nerve Block
n=37 Participants
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
n=40 Participants
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
|---|---|---|
|
Number of Participants Needing Additional Opioids
3 hours after TKA
|
5 Participants
|
3 Participants
|
|
Number of Participants Needing Additional Opioids
6 hours after TKA
|
8 Participants
|
13 Participants
|
|
Number of Participants Needing Additional Opioids
24 hours after TKA
|
27 Participants
|
23 Participants
|
|
Number of Participants Needing Additional Opioids
48 hours after TKA
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 3, 6, 24, 48 hours after primary total knee arthroplasty.Patient satisfaction rates will be evaluated using a 10 point scale from 0 (completely unsatisfied) to 10 (totally satisfied) at 3, 6, 24, 48 hours after surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=37 Participants
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
n=40 Participants
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
|---|---|---|
|
Rate of Patients Satisfaction
3 hours after TKA
|
8.8 score on a scale
Standard Deviation 1.4
|
8.9 score on a scale
Standard Deviation 1.8
|
|
Rate of Patients Satisfaction
6 hours after TKA
|
8.5 score on a scale
Standard Deviation 1.5
|
8.8 score on a scale
Standard Deviation 1.7
|
|
Rate of Patients Satisfaction
24 hours after TKA
|
8.1 score on a scale
Standard Deviation 1.7
|
8.4 score on a scale
Standard Deviation 1.5
|
|
Rate of Patients Satisfaction
48 hours after TKA
|
8.1 score on a scale
Standard Deviation 1.8
|
8.6 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 3, 6, 24, 48 hours after primary total knee arthroplasty.The number of patients with nausea and vomiting will be evaluated in both groups of patients.
Outcome measures
| Measure |
Femoral Nerve Block
n=37 Participants
The femoral nerve block was performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 20 mL around all the femoral nerve branches inside the proximal part of the femoral triangle.
|
Femoral Triangle & Adductor Canal Blocks
n=40 Participants
These two blocks will be performed together. The femoral triangle block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. The adductor canal block will be performed under the ultrasound guidance by a single injection of Bupivacaine 0.125% 10 mL at the level where the femoral artery and vein dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.
|
|---|---|---|
|
Number of Participants With Nausea or Vomiting
6 hours after TKA · Nausea
|
2 Participants
|
1 Participants
|
|
Number of Participants With Nausea or Vomiting
3 hours after TKA · Nausea
|
1 Participants
|
1 Participants
|
|
Number of Participants With Nausea or Vomiting
3 hours after TKA · Vomiting
|
0 Participants
|
0 Participants
|
|
Number of Participants With Nausea or Vomiting
3 hours after TKA · No nausea or vomiting
|
36 Participants
|
39 Participants
|
|
Number of Participants With Nausea or Vomiting
6 hours after TKA · Vomiting
|
0 Participants
|
1 Participants
|
|
Number of Participants With Nausea or Vomiting
6 hours after TKA · No nausea or vomiting
|
35 Participants
|
38 Participants
|
|
Number of Participants With Nausea or Vomiting
24 hours after TKA · Nausea
|
3 Participants
|
3 Participants
|
|
Number of Participants With Nausea or Vomiting
24 hours after TKA · Vomiting
|
0 Participants
|
1 Participants
|
|
Number of Participants With Nausea or Vomiting
24 hours after TKA · No nausea or vomiting
|
34 Participants
|
36 Participants
|
|
Number of Participants With Nausea or Vomiting
48 hours after TKA · Nausea
|
1 Participants
|
1 Participants
|
|
Number of Participants With Nausea or Vomiting
48 hours after TKA · Vomiting
|
1 Participants
|
0 Participants
|
|
Number of Participants With Nausea or Vomiting
48 hours after TKA · No nausea or vomiting
|
35 Participants
|
39 Participants
|
Adverse Events
Femoral Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Femoral Triangle & Adductor Canal Blocks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator Inna Jaremko
Lithuanian Univrsity of Health Sciences
Phone: +37064857386
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place