- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865344
Skin Conductance Fluctuations Per Sec and NRS to Monitor Pain
A Pilot Study for the PainMonitor During Standardized Painful Stimuli and no Stimuli to Calculate the Sensitivity and Specificity and Thereby the Accuracy of the Monitor
Study Overview
Status
Conditions
Detailed Description
Cardiac surgery patients will be consented for participation in this trial. They will be asked about their pre-existing pain, anxiety about the needle-insertion and anxiety about the outcome of the operation, and employment status. This information will be obtained from self-reported schemas from the patients about presence/absence of pain and anxiety (the response options: yes/no) (1). The intensities of pain and anxiety will measured with NRS also ranging from 0 to 10 with one statement in each range: 0 no pain and 10 worst possible pain, and 0 no anxiety and 10 worst possible anxiety. The participants were requested to mark the point at the line that best agreed with how the pain and anxiety were experienced. The intensity of pain scored more than 3 on NRS was considered to be equal to moderate pain or more (1). Furthermore, patients in the Cardiac Surgery unit will be observed when undergoing pre-defined standardized painful stimuli as part of the standard of care treatment prior to and during surgery. The proposed study is structured using three events.
- Event 1: no stimuli, the period before placement of an arterial catheter when the patient has been administered diazepam, but is awake and calm. The registration will be for 1 min, 1 min before anticipated arterial line placement.
- Event 2: standardized painful stimulus, arterial catheter placement, with diazepam as premedication. The registration will be during arterial catheter placement.
- Event 3: no stimuli; patient is anesthetized before intubation. The registration will be for 1 min 1 min before anticipated intubation.
- There will also be one skin conductance response per sec registration for 1 min and the NRS score, one day postoperatively, when asking the patient about any side effects from the study.
During all defined events, the subject's skin conductance responses will be evaluated using the PainMonitor, and the subject will be asked to report pain using the 10 point NRS scale when awake. Before intubation when the patient is anesthetized, without stimuli, it is defined that the patient has no pain.
During these events, the number of skin conductance responses/sec will be analyzed in the defined time period, and this value will be used for statistical analyses. NRS scores will be obtained after the event and the value of the felt pain during the event will be asked for.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oslo, Norway, 0027
- Acute Clinic, Rikshospitalet - Oslo University hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: Older than 18 years, patients scheduled for cardiac surgery.
- Patients admitted to the Cardiac Unit with cardiac disease.
- Patients able to verbally communicate pain level during or after the procedures.
- Pain medication following institutional standard care; only diazepam given before the painful procedure. During surgery, institutional standard care for sedation will be given.
Exclusion Criteria:
- Administration or anesthesia or analgesia other than diazepam prior to evaluation with the PainMonitor.
- Presence of any neurological disease affecting the peripheral nerves.
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Severe neuropathic disease
- Use of neostigmine before event 1, 2, and 3, see events below.
- Use of atropin
- Use of regional anesthesia at the extremity where the device electrodes are placed.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Heart surgery
Pain monitoring at different time periods
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin conductance responses per sec and NRS before and during painful procedures
Time Frame: 8 months
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8 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan F Bugge, MD.PhD, Head of the Anesthesia Thorax department
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REK sør-øst 2013/196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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