Clinical trial NCT01631695: Clinical Evaluation of Medasense Pain Monitor Performances
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Pain
Postoperative Pain
Lead sponsor: Medasense Biometrics Ltd
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgeries under general anesthesia, healthy or suffering from minor chronic diseases (ASA I-II)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-2
* Elective surgery under general anesthesia
* Baseline blood pressure \< (170\\100 mmHg), heart rate \< 100 bpm

Exclusion Criteria:

* Pregnancy or lactation
* History of severe cardiac arrhythmias
* Presence of any neuromuscular or neurological disease
* Use of central nervous system (CNS) -active medications
* Abuse of alcohol or illicit drugs
* History of mental retardation or any mental disease
* Any severe lung, liver, renal disease and uncontrolled diabetes mellitus
* Use of a α or β-adrenergic antagonist or anticholinergics
* Allergy to any of the drugs to be used during surgery
* Use of regional anesthesia

Primary outcomes:
measure: Changes in Medasense's non-invasive pain monitoring index in response to painful events.
timeFrame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Secondary outcomes:
measure: Changes in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli
timeFrame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
measure: Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli
timeFrame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
measure: Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs
timeFrame: before versus after analgesic drug administration
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Department of Anesthesiology, Rambam Health Care Campus
name: Ruth Edry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
citation: Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.