Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Summit Medical Products, Inc. | UNKNOWN |
| Teleflex | INDUSTRY |
Not provided
Not provided
Not provided
Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.
While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.
The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.
Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Femoral perineural local anesthetic infusion |
|
| Experimental | Experimental | Adductor canal perineural local anesthetic infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control: Femoral perineural local anesthetic infusion | Drug | The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hours Until Discharge Readiness | Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance. | 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Adequate Analgesia | The time in hours until adequate analgesia is defined as pain less than 4 on a Numeric Rating Scale of 0-10, with 0=no pain and 10=worst imaginable pain | First 7 postoperative days |
| Time Until Independence From Intravenous Analgesics of at Least 12 Hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian M Ilfeld, MD, MS | University California San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Medical Centers | San Diego | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9661552 | Background | Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019. | |
| 22221014 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental: Adductor Canal perineural local anesthetic infusion | Drug | The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion |
|
The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission) |
| First 7 postoperative days |
| Time Until Timed Up and Go Test Achieved | The timed-up-and-go (TUG) test measures the ability and speed of standing from a sitting position, walking 3 meters and returning to the original seated position independent from the assistance of healthcare personnel. This variable measured the time in hours until the patient could successfully achieve this test independently, regardless of the amount of time required. | Hours |
| Time Until Ambulation at Least 30 Meters | The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters) | 7 postoperative days |
| Pain Level | The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain | Postoperative Days 1-3 |
| Opioid Consumption | Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams | Postoperative Days 0-3 |
| Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4. |
| 22745116 | Background | Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC, Ferguson EJ, Madison SJ. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. Anesth Analg. 2012 Sep;115(3):721-7. doi: 10.1213/ANE.0b013e318261f326. Epub 2012 Jun 28. |
| 19916251 | Background | Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84. |
| 19901788 | Background | Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available. |
| 22834681 | Background | Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26. |
| 21039357 | Background | Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29. |
| FG001 | Experimental | Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. |
| BG001 | Experimental | Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. |
| 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 |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| 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 | Hours Until Discharge Readiness | Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance. | Posted | Median | Inter-Quartile Range | hours | 7 postoperative days |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Adequate Analgesia | The time in hours until adequate analgesia is defined as pain less than 4 on a Numeric Rating Scale of 0-10, with 0=no pain and 10=worst imaginable pain | Posted | Mean | Standard Deviation | Hours | First 7 postoperative days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time Until Independence From Intravenous Analgesics of at Least 12 Hours | The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission) | Posted | Mean | Standard Deviation | Hours | First 7 postoperative days |
| |||||||||||||||||||||||||||||||
| Secondary | Time Until Timed Up and Go Test Achieved | The timed-up-and-go (TUG) test measures the ability and speed of standing from a sitting position, walking 3 meters and returning to the original seated position independent from the assistance of healthcare personnel. This variable measured the time in hours until the patient could successfully achieve this test independently, regardless of the amount of time required. | Posted | Mean | Standard Deviation | Hours | Hours |
| |||||||||||||||||||||||||||||||
| Secondary | Time Until Ambulation at Least 30 Meters | The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters) | Posted | Mean | Standard Deviation | Hours | 7 postoperative days |
| |||||||||||||||||||||||||||||||
| Secondary | Pain Level | The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain | Posted | Mean | Standard Deviation | score on a scale | Postoperative Days 1-3 |
| |||||||||||||||||||||||||||||||
| Secondary | Opioid Consumption | Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams | Posted | Mean | Standard Deviation | milligrams | Postoperative Days 0-3 |
|
First postoperative week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. | 0 | 41 | 3 | 41 | 0 | 41 |
| EG001 | Experimental | Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. | 0 | 39 | 2 | 39 | 0 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | A fall either from standing or during walking |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Ilfeld | University of California San Diego | 858-822-2171 | bilfeld@ucsd.edu |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|