Pain, Postoperative Clinical Trial
Official title:
Does Pain Reporting Accuracy Relates to the Intensity of Acute Post-operative Pain and Analgesic Drug Consumption?
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age >18 - Candidates to Head & Neck elective surgery Exclusion Criteria: - Presence of diagnosed psychiatric disorders, cognitive and /or neurological deficits; - Use of analgesic, anti-depressants or anti-anxiolytics medications on a regular basis (except for oral contraceptives); - Pregnancy. - Inability to give informed consent, communicate, and understand the purpose and instructions of this study. |
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Carmel Medical Center | University of Haifa |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in acute post-operative pain throughout the hospitalization period | Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable". | From post-surgery recovery until discharge at specific time points: pain report (NPS) at the time of analgesic medication consumption, an hour after administration of the drug, in addition to regular monitoring of every 6 hours during hospitalization. | |
Primary | Amount of analgesic drugs consumption I | Quantification of the amount of analgesic drugs consumption will be performed by counting the number of times an SOS drug has been given. The SOS medications (beyond analgesic protocol) include Optalgin PO / Acamol IV / Oxycodone PO/ tramal IV. | From post-surgery recovery until discharge (24-48 hours after surgery) | |
Secondary | Amount of analgesic drugs consumption II | Quantification of the amount of analgesic drugs consumption will be performed by conversion of opiates dosage into morphine units, out of the SOS medications that were taken. | From post-surgery recovery until discharge (24-48 hours after surgery) | |
Secondary | Amount of analgesic drugs consumption III | Quantification of the amount of analgesic drugs consumption will be performed by calculating the grams of NSAIDs consumption, out of the SOS medications that were taken. | From post-surgery recovery until discharge (24-48 hours after surgery) |
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