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Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores

13 août 2019 mis à jour par: Hospital for Special Surgery, New York
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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

50

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients undergoing surgery for unilateral Total Hip Replacement and Total Knee Replacement.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Numeric Pain Rating Scale
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Nausea
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2010

Achèvement primaire (Réel)

1 juillet 2011

Achèvement de l'étude (Réel)

1 juillet 2011

Dates d'inscription aux études

Première soumission

17 février 2015

Première soumission répondant aux critères de contrôle qualité

31 mars 2015

Première publication (Estimation)

3 avril 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 août 2019

Dernière vérification

1 août 2019

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 10106 (Autre identifiant: CTEP)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Douleur postopératoire

Essais cliniques sur Total Hip Replacement (THR) and Total Knee Replacement (TKR)

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