Trial Outcomes & Findings for Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block (NCT NCT01966263)
NCT ID: NCT01966263
Last Updated: 2023-01-25
Results Overview
The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
one year
Results posted on
2023-01-25
Participant Flow
Participant milestones
| Measure |
Local Infiltration Analgesia (LIA)
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
LIA of the anterior capsule of the knee: the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
LIA of the subcutaneous tissue of the knee: the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
|
Femoral Nerve Block (FNB)
a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
FNB with catheter: pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block
Baseline characteristics by cohort
| Measure |
Local Infiltration Analgesia (LIA)
n=40 Participants
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
LIA of the anterior capsule of the knee: the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
LIA of the subcutaneous tissue of the knee: the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
|
Femoral Nerve Block (FNB)
n=40 Participants
a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
FNB with catheter: pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
66 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
65 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
BMI
|
28.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
ASA physical status
ASA 1
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
ASA physical status
ASA 2
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
ASA physical status
ASA 3
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Side of surgery
left
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Side of surgery
right
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: One patient from group FNB was excluded due to revision surgery of the knee; one patient from group FNB withdrew from follow up due to the development of a malignancy. One patient in group FNB and three patients in group LIA were excluded due to TKA of the contralateral knee. In group LIA one patient withdrew from follow up due to the development of a severe eye disorder requiring intensive treatment. One patient from group FNB was unable to perform the 6MWT due to severe backache.
The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.
Outcome measures
| Measure |
Local Infiltration Analgesia (LIA)
n=36 Participants
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
LIA of the anterior capsule of the knee: the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
LIA of the subcutaneous tissue of the knee: the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
|
Femoral Nerve Block (FNB)
n=37 Participants
a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
FNB with catheter: pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
|
|---|---|---|
|
Stair Climbing Task (SCT)
|
14.3 seconds
Standard Deviation 7.1
|
13.8 seconds
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One patient from group FNB was excluded due to revision surgery of the knee; one patient from group FNB withdrew from follow up due to the development of a malignancy. One patient in group FNB and three patients in group LIA were excluded due to TKA of the contralateral knee. In group LIA one patient withdrew from follow up due to the development of a severe eye disorder requiring intensive treatment. One patient from group FNB was unable to perform the 6MWT due to severe backache.
The TUG assesses basic mobility skill as well as strength, balance, and agility. Originally developed for frail elderly people as the "Get-Up and Go Test" in 1986, it was adapted in 1991 to include the "time" component. The TUG is used in a range of populations from children to the elderly and for many conditions, including osteoarthritis, joint arthroplasty, rheumatoid arthritis, hip fractures, stroke, vertigo, and cerebral palsy.
Outcome measures
| Measure |
Local Infiltration Analgesia (LIA)
n=36 Participants
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
LIA of the anterior capsule of the knee: the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
LIA of the subcutaneous tissue of the knee: the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
|
Femoral Nerve Block (FNB)
n=37 Participants
a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
FNB with catheter: pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
|
|---|---|---|
|
Timed Up and Go Test (TUG)
|
7.8 seconds
Standard Deviation 1.9
|
7.6 seconds
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One patient from group FNB was excluded due to revision surgery of the knee; one patient from group FNB withdrew from follow up due to the development of a malignancy. One patient in group FNB and three patients in group LIA were excluded due to TKA of the contralateral knee. In group LIA one patient withdrew from follow up due to the development of a severe eye disorder requiring intensive treatment. One patient from group FNB was unable to perform the 6MWT due to severe backache.
The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities. Used in many conditions, such as osteoarthritis, cardiopulmonary disease, stroke, traumatic brain injury, patients who have undergone an amputation, Parkinson's disease, and Alzheimer's disease, as well as in elderly populations and children.
Outcome measures
| Measure |
Local Infiltration Analgesia (LIA)
n=36 Participants
local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
LIA of the anterior capsule of the knee: the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
LIA of the subcutaneous tissue of the knee: the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
|
Femoral Nerve Block (FNB)
n=36 Participants
a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
FNB with catheter: pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
|
|---|---|---|
|
Six Minute Walking Test (6MWT)
|
489 meters
Standard Deviation 71
|
505 meters
Standard Deviation 84
|
Adverse Events
Local Infiltration Analgesia (LIA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Femoral Nerve Block (FNB)
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