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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Weill Medical College of Cornell University | OTHER |
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Pain has been defined as a subjective experience. Various pain assessment tools, (such as NRS) have been developed and validated to objectively monitor and treat pain. There are certain patient populations, in whom, the current pain assessment tools cannot be used effectively due to communication problems such as cognitively impaired patients. In the US, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that would objectively measure pain, there is also risk of under treatment and overtreatment of pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain levels objectively, will help to achieve above goals. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.
Pain was defined as the fifth vital sign, and assessment and treatment of pain were introduced as a mandatory standard. This directive has improved pain management and patient satisfaction, but it has also increased the incidence of opioid-related side effects including respiratory depression with fatal outcomes. The most accepted pain assessment is the patients' self-report of their pain. Various pain assessment tools, such as the numeric rating scale (NRS), have been developed and validated. The self-report of pain is defined as the gold standard even though it may be influenced by anxiety, level of education, employment status, age and sex. The NRS is reported to be more clinically applicable than the visual analogue scale (0-100mm) specifically in elderly and in patients on opioids.The current self-report assessment tools cannot be used effectively in certain patient populations who are unable to report their pain such as cognitively impaired patients, sedated patients and children. In this group of patients, there is a risk of inadequate or overtreatment of pain which in turn may lead to negative outcomes. When patients cannot report their pain, observational and physiological parameters are used. Therefore, a monitor to objectively assess the pain would be clinically valuable. An ideal monitor would be non-invasive, fast-reacting, continuous (real-time), sensitive and specific to assess pain.
The Skin Conductance Algesimeter (SCA) measures skin sympathetic nerve activity mirrored by variations in skin conductance responses (SCR) on the palmar side of the hand. Each time the skin sympathetic nervous system is activated, the palmar and plantar sweat glands fill up with sweat. Due to electrolytes present in sweat, the skin resistance decreases and the skin conductance increases. The reabsorption of the sweat in the sweat glands reverses this process, and leads to a decrease in skin conductance. SCR can be monitored by SCA and this response is directly linked to skin sympathetic nerve activity. The number of SCR is a measure of how often the skin sympathetic nerves fire. The numbers of SCR increase during emotionally stressful stimuli like moderate-severe pain, and this is different than the painless or mild pain conditions.
To examine how the SCR is influenced by stimuli other than pain postoperatively, it is important that SCR is studied in the absence of moderate-severe pain.The goal of this study is to evaluate the correlation of SCR with emotional stressors other than pain such as: anxiety, nausea, and intellectual task performance. We hypothesized that SCR would not show a significant positive correlation with emotional stressors other than pain, thereby will increase the specificity of SCR as a viable physiological monitor for the assessment of moderate-severe pain postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Hip Replacement (THR) and Total Knee Replacement (TKR) | 25 patients receiving a THR and 25 patients receiving aTKR. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Replacement (THR) and Total Knee Replacement (TKR) | Procedure | Total Hip Replacement is a surgical procedure where the cartilage and bone of the hip joint is replaced with artificial materials. Total Knee Replacement involves replacement of all three compartments of the knee the medial, the lateral and patellofemoral compartment. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale | Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain) | Baseline, Postoperative day 1, Postoperative Day 2 |
| Skin Conductance Response | A skin conductance response is defined as a minimum followed by a maximum in conductance values micro Siemens (mS). | Baseline, Postoperative day 1, Postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea | Nausea was assessed by patients' self-report on their level of nausea on a 0-3 scale: 0=No nausea; 1=Mild nausea; 2=Moderate nausea; 3=Severe nausea. | Baseline, Postoperative day 1, Postoperative day 2 |
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Inclusion Criteria:
Exclusion Criteria:
Autonomic neuropathy
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Patients undergoing surgery for unilateral Total Hip Replacement and Total Knee Replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Semih Gungor, MD | Hospital for Special Surgery, New York | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10446819 | Background | Devlin JW, Boleski G, Mlynarek M, Nerenz DR, Peterson E, Jankowski M, Horst HM, Zarowitz BJ. Motor Activity Assessment Scale: a valid and reliable sedation scale for use with mechanically ventilated patients in an adult surgical intensive care unit. Crit Care Med. 1999 Jul;27(7):1271-5. doi: 10.1097/00003246-199907000-00008. | |
| 1798033 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Hip Replacement (THR) | Patients undergoing unilateral hip replacement (THR) that are between the ages of 18 and 85. Patients with the condition of chronic pain, using long acting opioid medication >6 months will be excluded. |
| FG001 | Total Knee Replacement (TKR) | Patients undergoing unilateral knee replacement (TKR) that are between the ages of 18 and 85. Patients with the condition of chronic pain, using long acting opioid medication >6 months will be excluded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | THR and TKR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Numeric Pain Rating Scale | Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Postoperative day 1, Postoperative Day 2 |
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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 | THR and TKR |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gungor | HSS | 212.606.1206 | GungorS@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 |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| D013912 | Threonine |
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Kunimoto M, Kirno K, Elam M, Wallin BG. Neuroeffector characteristics of sweat glands in the human hand activated by regular neural stimuli. J Physiol. 1991 Oct;442:391-411. doi: 10.1113/jphysiol.1991.sp018799. |
| 15954962 | Background | Storm H, Shafiei M, Myre K, Raeder J. Palmar skin conductance compared to a developed stress score and to noxious and awakening stimuli on patients in anaesthesia. Acta Anaesthesiol Scand. 2005 Jul;49(6):798-803. doi: 10.1111/j.1399-6576.2005.00665.x. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | Skin Conductance Response | A skin conductance response is defined as a minimum followed by a maximum in conductance values micro Siemens (mS). | Posted | Mean | Standard Deviation | micro Siemens (mS) | Baseline, Postoperative day 1, Postoperative day 2 |
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| Secondary | Nausea | Nausea was assessed by patients' self-report on their level of nausea on a 0-3 scale: 0=No nausea; 1=Mild nausea; 2=Moderate nausea; 3=Severe nausea. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Postoperative day 1, Postoperative day 2 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D000601 | Amino Acids, Essential |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D021542 | Amino Acids, Neutral |
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|---|---|
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| Title | Measurements |
|---|---|
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