Clinical Evaluation of Medasense Pain Monitor Performances

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631695
• Other study ID #: Medasense002
• Secondary ID: 0281-09-RMB
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: October 27, 2013
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: October 2013
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 a or ß-adrenergic antagonist or anticholinergics

• Allergy to any of the drugs to be used during surgery

• Use of regional anesthesia

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• Postoperative Pain
• Surgery

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

Treister R, Kliger M, Zuckerman G, Goor Aryeh I, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-14. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Medasense's non-invasive pain monitoring index in response to painful events.	outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.	before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)	No
Secondary	Changes in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli	Outcome measures will be assessed one minute before painful event, and will be compared to measures taken during the painful event.	before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)	No
Secondary	Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli	Outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.	before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)	No
Secondary	Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs	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.	before versus after analgesic drug administration	No