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| Name | Class |
|---|---|
| University of Massachusetts, Worcester | OTHER |
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The application of a tourniquet for 5 minutes and subsequent reperfusion before actual inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases the level of local inflammation and therefore postoperative pain in response to reperfusion of the ischemic extremity.
During knee surgery your surgeon routinely uses a device called a tourniquet that allows us to temporarily cut of blood supply to the site of surgery. This helps to reduce blood loss and improves operating conditions. When allowing blood back into your leg at the end of the procedure, debris (bone, fat, tissue breakdown products and cement from the surgery) gets washed out and gains access to the rest of your body. In the vast majority of cases this event bares no major clinical consequences, but can rarely result in signs of inflammation of various body systems. Patients with evidence of impaired organ system function such as pre-existing lung and heart disease may be more vulnerable. Previous studies suggest that cutting off the blood supply for a short period of time just before a prolonged episode, could lead to a decrease in the extent of tissue breakdown products in this extremity and may thus be associated with a decrease in the inflammation of other organ systems. We propose to study this theory in knee surgery patients by looking at levels of markers of inflammation present in the blood before and after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ishcemic Preconditioning | Active Comparator | In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). |
|
| Control | No Intervention | In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ischemic Preconditioning | Procedure | In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery | Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group. | 48hrs after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Epidural Volume | Postoperative pain management included an epidural infusion of 10mcg/ml bupivacaine 0.06%/hydromorphone with a basal rate of 4 mL, a demand dose of 4 mL, and a lockout of 10 minutes. Basal rates were reduced to 2 mL and 0 mL in the morning of postoperative Days 1 and 2, respectively and epidural catheters removed on postoperative Day 2. Overall epidural volume was the total volume given over 48 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros G. Memtsoudis, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23761178 | Result | Memtsoudis SG, Stundner O, Yoo D, Gonzalez Della Valle A, Boettner F, Bombardieri AM, Jules-Elysee K, Poultsides L, Ma Y, Sculco TP. Does limb preconditioning reduce pain after total knee arthroplasty? A randomized, double-blind study. Clin Orthop Relat Res. 2014 May;472(5):1467-74. doi: 10.1007/s11999-013-3106-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ishcemic Preconditioning | In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
| FG001 | Control | In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ishcemic Preconditioning | In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| 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 | Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery | Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group. | Posted | Mean | 95% Confidence Interval | score on a scale | 48hrs after surgery |
|
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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 | Ishcemic Preconditioning | In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). Ischemic Preconditioning: In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stavros Memtsoudis | Hospital for Special Surgery | 646-797-8522 | 8522 | MemtsoudisS@hss.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D019194 | Ischemic Preconditioning |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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|
| At 48hrs after surgery |
| Muscle Oxygenation Over Calf at 48h After Surgery | muscle tissue oxygenation was measured using a novel noninvasive near infrared spectroscopy device at baseline and at 48 hours postoperatively | At 48 hrs after surgery |
| Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively | At 24 hours postoperatively |
| Periarticular Circumference of the Knee at 6h, 24h, and 48h | Periarticular circumference of the knee as compared to contralateral side as crude marker of swelling at 6h, 24, and 48h postoperatively. The data from the specified time points (6h, 24h, and 48h) were combined and the average value was reported for each arm/group. | measured at 6 hours, 24 hours, and 48 hours |
| Hospital Length of Stay | Up to discharge date |
| Physical Therapy Milestone | Amount of time until patients reached their physical therapy milestone (40 ft ambulation) during admission | Up to discharge date |
| Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively | 24 hours postoperatively |
| Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively | 24 hours postoperatively |
| BG001 | Control | In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Control | In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. |
|
|
|
| Secondary | Overall Epidural Volume | Postoperative pain management included an epidural infusion of 10mcg/ml bupivacaine 0.06%/hydromorphone with a basal rate of 4 mL, a demand dose of 4 mL, and a lockout of 10 minutes. Basal rates were reduced to 2 mL and 0 mL in the morning of postoperative Days 1 and 2, respectively and epidural catheters removed on postoperative Day 2. Overall epidural volume was the total volume given over 48 hours. | Posted | Mean | Standard Deviation | mL | At 48hrs after surgery |
|
|
|
|
| Secondary | Muscle Oxygenation Over Calf at 48h After Surgery | muscle tissue oxygenation was measured using a novel noninvasive near infrared spectroscopy device at baseline and at 48 hours postoperatively | Posted | Mean | Standard Deviation | percentage of muscle tissue | At 48 hrs after surgery |
|
|
|
|
| Secondary | Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively | IL-6 levels could not be measured for all patients. | Posted | Median | Inter-Quartile Range | pg/ml | At 24 hours postoperatively |
|
|
|
|
| Secondary | Periarticular Circumference of the Knee at 6h, 24h, and 48h | Periarticular circumference of the knee as compared to contralateral side as crude marker of swelling at 6h, 24, and 48h postoperatively. The data from the specified time points (6h, 24h, and 48h) were combined and the average value was reported for each arm/group. | Posted | Mean | Standard Deviation | cm | measured at 6 hours, 24 hours, and 48 hours |
|
|
|
|
| Secondary | Hospital Length of Stay | Posted | Median | Inter-Quartile Range | hours | Up to discharge date |
|
|
|
|
| Secondary | Physical Therapy Milestone | Amount of time until patients reached their physical therapy milestone (40 ft ambulation) during admission | Posted | Median | Inter-Quartile Range | days | Up to discharge date |
|
|
|
|
| Secondary | Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively | some patients were lost to follow up. | Posted | Mean | Standard Deviation | cells/mm^3 | 24 hours postoperatively |
|
|
|
|
| Secondary | Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively | some patients were lost to follow up. | Posted | Median | Inter-Quartile Range | pg/ml | 24 hours postoperatively |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |