Clinical Evaluation of Medasense Pain Monitor Performances
|ClinicalTrials.gov Identifier: NCT01631695|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : October 29, 2013
In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).
The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.
|Condition or disease|
|Surgery Pain Postoperative Pain|
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the visual analog scale (VAS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.
During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. Therefore, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.
In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.
|Study Type :||Observational|
|Actual Enrollment :||96 participants|
|Official Title:||Evaluation of the Performances of Medasense Pain Monitor During General Anesthesia and Postoperative Recovery Compared to Pain Related Physiological Indicators and to Subjective Assessment of Pain by Anesthesiologist|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
- Changes in Medasense's non-invasive pain monitoring index in response to painful events. [ Time Frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion) ]outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.
- Changes in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli [ Time Frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion) ]Outcome measures will be assessed one minute before painful event, and will be compared to measures taken during the painful event.
- Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli [ Time Frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion) ]Outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.
- Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs [ Time Frame: before versus after analgesic drug administration ]
Outcome measures will be assessed one minute before administration of analgesic drug, and will be compared to measures taken one minute after.
Participants will be followed for the duration of surgery and Postoperative Recovery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631695
|Rambam Health Care Campus|
|Haifa, Israel, 31096|
|Principal Investigator:||Ruth Edry, MD||Department of Anesthesiology, Rambam Health Care Campus|