Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients undergoing unilateral THR and TKR who are between the ages of 18 and 85 regardless of the anesthesia and postoperative analgesia type.
- Patients participating in other studies may participate in this study as well
- Patients with Motor Activity Assessment Scale (MAAS) Score of 3 and 4
Exclusion Criteria:
- Age <18, >85
- History of chronic pain as defined by use of long acting opioid medication > 6 months duration.
- MAAS Score of <3 and >4.
- Anticholinergic agent use
- Patients with the following conditions:
Autonomic neuropathy
- Pacemaker/AICD
- Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated)
- Allergy to adhesive tape
- Communication barriers
- Bilateral Procedures
- Patient with diagnosis of
- Dysautonomia
- Sympathetic dysfunction such as: Raynaud disease, Buerger disease
- Disorders of sweating such as: Acquired idiopathic generalized anhidrosis
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numeric Pain Rating Scale
時間枠:Baseline, Postoperative day 1, Postoperative Day 2
|
Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain)
|
Baseline, Postoperative day 1, Postoperative Day 2
|
|
Skin Conductance Response
時間枠:Baseline, Postoperative day 1, Postoperative day 2
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nausea
時間枠:Baseline, Postoperative day 1, Postoperative day 2
|
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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
術後の痛みの臨床試験
-
Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
-
Dexa Medica Group完了