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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001008-13 | EudraCT Number | ||
| NL43965.072.13 | Other Identifier | CCMO register |
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The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track rehabilitation protocol has been developed. The literature is not yet conclusive about the optimal anesthestic technique. The optimal technique should support fast mobilization by giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is shortened. But does fast recovery lead to better functional outcome? The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Infiltration Analgesia (LIA) | Active Comparator | 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 |
|
| Femoral Nerve Block (FNB) | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIA of the posterior capsule of the knee | Procedure | the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stair Climbing Task (SCT) | The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go Test (TUG) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rudolf Stienstra, MD, PhD | Sint Maartenskliniek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Maartenskliniek | Ubbergen | 6574NA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30236246 | Derived | Fenten MGE, Bakker SMK, Scheffer GJ, Wymenga AB, Stienstra R, Heesterbeek PJC. Femoral nerve catheter vs local infiltration for analgesia in fast track total knee arthroplasty: short-term and long-term outcomes. Br J Anaesth. 2018 Oct;121(4):850-858. doi: 10.1016/j.bja.2018.05.069. Epub 2018 Jul 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| LIA of the anterior capsule of the knee | Procedure | the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine. |
|
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| LIA of the subcutaneous tissue of the knee | Procedure | the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure. |
|
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| FNB with catheter | Procedure | 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 |
|
|
| 1 year |
| Six Minute Walking Test (6MWT) | 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. | 1 year |
| FG001 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| ASA physical status | For full table on the ASA Physical Status Classification system and the use of examples see https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system. In short: ASA 1: normal healthy patient; ASA 2 a patient with mild systemic disease; ASA 3 A patient with severe systemic disease, ASA 4 a patient with severe systemic disease that is a constant thread to life; ASA 5 a moribunt patient who is not expected to survive without the operation; ASA 6 a declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
| |||||||||||||||
| Side of surgery | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stair Climbing Task (SCT) | The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance. | 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. | Posted | Mean | Standard Deviation | seconds | one year |
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| ||||||||||||||||||||||||||||
| Secondary | Timed Up and Go Test (TUG) | 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. | 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. | Posted | Mean | Standard Deviation | seconds | 1 year |
| ||||||||||||||||||||||||||||||
| Secondary | Six Minute Walking Test (6MWT) | 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. | 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. | Posted | Mean | Standard Deviation | meters | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 40 | 0 | 40 | ||
| EG001 | 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 | 0 | 40 | 0 | 40 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maaike Fenten | Sint Maartenskliniek Nijmegen | 31243659111 | 2941 | m.fenten@maartenskliniek.nl |
| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D057785 | Catheters |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004864 | Equipment and Supplies |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Male |
|
| ASA 2 |
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| ASA 3 |
|
| right |
|
| OG001 | 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 |
|
|
| OG001 | 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 |
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