Trial Outcomes & Findings for Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty (NCT NCT02121392)
NCT ID: NCT02121392
Last Updated: 2020-10-20
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
12 hours postoperatively and 20 hours after placement of catheter
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Prior to Intervention
STARTED
|
83
|
82
|
|
Prior to Intervention
COMPLETED
|
35
|
41
|
|
Prior to Intervention
NOT COMPLETED
|
48
|
41
|
|
After Placement of AC Block vs Sham
STARTED
|
35
|
41
|
|
After Placement of AC Block vs Sham
COMPLETED
|
32
|
38
|
|
After Placement of AC Block vs Sham
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Prior to Intervention
Protocol Violation
|
40
|
35
|
|
Prior to Intervention
Withdrawal by Subject
|
8
|
6
|
|
After Placement of AC Block vs Sham
Protocol Violation
|
3
|
2
|
|
After Placement of AC Block vs Sham
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.18 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
64.44 years
STANDARD_DEVIATION 8.77 • n=7 Participants
|
63.87 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
American Society of Anaesthesiologists Score
|
2.66 units on a scale
STANDARD_DEVIATION 0.48 • n=5 Participants
|
2.79 units on a scale
STANDARD_DEVIATION 0.41 • n=7 Participants
|
2.68 units on a scale
STANDARD_DEVIATION 0.47 • n=5 Participants
|
|
Body Mass Index (Kg/m^2)
|
34.38 kg/m^2
STANDARD_DEVIATION 6.14 • n=5 Participants
|
33.58 kg/m^2
STANDARD_DEVIATION 7.11 • n=7 Participants
|
33.94 kg/m^2
STANDARD_DEVIATION 6.65 • n=5 Participants
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
51.68 units on a scale
STANDARD_DEVIATION 14.23 • n=5 Participants
|
50.78 units on a scale
STANDARD_DEVIATION 18.94 • n=7 Participants
|
51.19 units on a scale
STANDARD_DEVIATION 16.85 • n=5 Participants
|
|
knee extension (deg)
|
1.54 degrees
STANDARD_DEVIATION 3.00 • n=5 Participants
|
4.24 degrees
STANDARD_DEVIATION 7.14 • n=7 Participants
|
3.02 degrees
STANDARD_DEVIATION 5.78 • n=5 Participants
|
|
knee flexion (deg)
|
103.43 degrees
STANDARD_DEVIATION 18.62 • n=5 Participants
|
97.41 degrees
STANDARD_DEVIATION 26.23 • n=7 Participants
|
100.13 degrees
STANDARD_DEVIATION 23.12 • n=5 Participants
|
|
knee Range of motion (deg)
|
101.89 degrees
STANDARD_DEVIATION 19.97 • n=5 Participants
|
93.18 degrees
STANDARD_DEVIATION 27.24 • n=7 Participants
|
97.11 degrees
STANDARD_DEVIATION 24.43 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hours postoperatively and 20 hours after placement of catheterOutcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Morphine Equivalents
12 hours postoperatively
|
11.9 milligrams of morphine
Standard Deviation 14
|
12.5 milligrams of morphine
Standard Deviation 15
|
|
Morphine Equivalents
20 hours after placement of catheter
|
96.5 milligrams of morphine
Standard Deviation 47
|
73.9 milligrams of morphine
Standard Deviation 38
|
SECONDARY outcome
Timeframe: 12 hours postoperatively and 20 hours after placement of catheterThe visual analog scale (VAS) is a pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single mark placed at one point along the length of a line that represents a continuum between the two ends of the scale-"no pain" on the left end of the scale (equal to a score of 0) and the "worst pain" on the right end of the scale (equal to a score of 100).
Outcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Visual Analog Score for Pain
12 hours postoperatively
|
27.9 mm
Standard Deviation 16
|
26.9 mm
Standard Deviation 19
|
|
Visual Analog Score for Pain
20 hours after placement of catheter
|
36.4 mm
Standard Deviation 18
|
28.6 mm
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Daily on postoperative days one and twoOutcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Physical Therapy Ambulation Distance
Postoperative Day 1
|
13.8 meters
Standard Deviation 15.6
|
17.6 meters
Standard Deviation 21
|
|
Physical Therapy Ambulation Distance
Postoperative Day 2
|
32.5 meters
Standard Deviation 26.2
|
39.4 meters
Standard Deviation 31.8
|
SECONDARY outcome
Timeframe: within first 3 days (plus or minus 3 days) after surgeryOutcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Number of Hospital Days Until Discharge Criteria Are Met
|
2.42 Days
Standard Deviation 0.86
|
2.67 Days
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: within first 3 days (plus or minus 3 days) after surgeryOutcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Number of Participants With Bleeding Complications at Adductor Canal Nerve Block Catheter Site
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within first 3 days (plus or minus 3 days) after surgeryOutcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Number of Participants With Adverse Events Related to Adductor Canal Nerve Block Catheter
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 weeksThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales yields a total WOMAC score.
Outcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=38 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
3 weeks
|
37.8 score on a scale
Standard Deviation 13
|
29.1 score on a scale
Standard Deviation 15
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
6 weeks
|
32.9 score on a scale
Standard Deviation 14
|
27.9 score on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: postoperative day 1 and 2Knee range of motion (ROM) was measured (in degrees) during physical therapy.
Outcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Range of Motion
Postoperative Day 1
|
51.4 degrees
Standard Deviation 17
|
40.6 degrees
Standard Deviation 14
|
|
Range of Motion
Postoperative Day 2
|
71.3 degrees
Standard Deviation 19
|
62.5 degrees
Standard Deviation 21
|
SECONDARY outcome
Timeframe: 3 and 6 weeksOutcome measures
| Measure |
Epidural Catheter Without Adductor Canal Nerve Block Catheter
n=32 Participants
Patients randomized to the sham catheter will have a sham catheter placed on the skin and obscured with an opaque dressing and attached to a functional pump which will not be turned on.
Adductor Canal Nerve Block Sham Catheter: Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
Bupivacaine: In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
|
Epidural Catheter With Adductor Canal Nerve Block Catheter
n=39 Participants
Patients will receive a continuous adductor canal block placed under ultrasound guidance under the supervision of an attending physician who is fellowship trained.
Adductor Canal Nerve Block Catheter: ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the
|
|---|---|---|
|
Range of Motion at 3 and 6 Week Follow up
3 weeks
|
98.2 degrees
Standard Deviation 11.5
|
94.3 degrees
Standard Deviation 13
|
|
Range of Motion at 3 and 6 Week Follow up
6 weeks
|
109 degrees
Standard Deviation 14
|
105 degrees
Standard Deviation 10.2
|
Adverse Events
Epidural Catheter Without Adductor Canal Nerve Block Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epidural Catheter With Adductor Canal Nerve Block Catheter
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place