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Experimental Pain Reporting Accuracy and Clinical Post-operative Pain

NCT03854669 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-28

No results posted yet for this study

Summary

Pain is a subjective experience that differs in intensity from one person to another. Appropriate medical care relies on an accurate assessment of the patients' condition. However, when it comes to subjective assessment, accurate assessment is a challenge.

The most common tools used to estimate pain intensity depend on patient pain reports on a numerical pain scale (NPS) or a similar scales. Although these tools are widely used, there is a tendency to ignore the fact that the reliability and accuracy of pain reports are strongly influenced not only by the measuring instrument, but also by the person who uses it. A method has recently been developed to assess the accuracy of pain reports, and in a series of studies it has been found that the more accurate a person is in pain reports in response to stimulation,the smaller his placebo effect is .The aim of the study is to investigate whether assessing the accuracy of a person's pain reports can predict who will experience intensified post-operative pain and post-operative analgesic medications intake.The study will include 40 patients undergoing elective head \& neck surgery. The study will be conducted prospectively and will include one pre-operative meeting to assess the accuracy of pain reports using the Focused Analgesia Selection Test (FAST). Patients will also complete pain-related psychological questionnaires during the session. In addition, post-operative pain measurements (NPS), and the use of pain relieving drugs (SOS) will be taken until release.

Conditions

  • Surgical Procedure, Unspecified
  • Pain, Postoperative
  • Ear, Nose, and Throat (ENT) Disease

Interventions

DEVICE

pain reporting accuracy

pain reporting accuracy will be assessed by the Focused Analgesia Selection Task (FAST) procedure. The FAST is based on recording a subject's pain reports in response to repeated administration of thermal noxious stimuli of various intensities, applied on the non-dominant arm with the Medoc® Thermal Sensory Analyzer II. The subjects will receive 1 of 7 designated temperatures (44°C, 45°C, 46°C, 47°C, 48°C, 49°C, and 50°C), each presented 7 times in a random block-ordered design (49 stimuli in total).

Sponsors & Collaborators

  • University of Haifa

    collaborator OTHER

  • Carmel Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854669 on ClinicalTrials.gov