RecruitingACTRN12610000454077

The relationship between the numeric rating scale, as a subjective measure of postoperative pain, and the plasma levels of catecholamines

The relationship between the numeric rating scale, as a subjective measure of postoperative pain, and the plasma levels of catecholamines in patients undergoing non-emergency minor surgery


Sponsor

Thomas Ledowski

Enrollment

85 participants

Start Date

Mar 1, 2010

Study Type

Observational

Conditions

Summary

It is commonly believed that acute postoperative pain can lead to an impaired outcome by means of stress hormone provoked physiological changes (e.g. hyperglycaemia, altered immune response, increased myocardial oxygen consumption). However, it has not yet been investigated whether or not pain that is often measured by means of subjective pain scales (e.g. numeric rating scale, NRS) actually correlates with changes in the plasma level of stress hormones. Aim of this study is to investigate the relationship between the subjective NRS score (0-10; 0= no pain, 10 = worst pain) and the plasma levels of adrenaline and noradrenaline. Furthermore, the correlation between these parameters and other non-invasive measures of pain (heart rate [HR], blood pressure [BP], respiration rate [RR], heart rate variability [HRV]) will be investigated. For this purpose, 85 patients scheduled for non-emergency plastic surgery will be included in the trial. On arrival in the recovery room, 4 ml blood will be taken from a cannula sited during the anaesthetic into the cubital fossa to measure plasma levels of catecholamines. Simultaneously, HR, BP and RR will be recorded as part of the recovery room protocol and the patient will be asked to rate their pain on the NRS. In addition, data from the connected electrocardiogram will be downloaded onto a laptop PC to calculate parameters of HRV by means of the MEMCALC method: total power, low frequency, high frequency, the low: high frequency ratio and a non-linear approach, ultra-short entropy. These HRV parameters are purely mathematical calculations (hence “no touch” technique) and have previously shown correlations with the sympatho-vagal balance. At the time of discharge from the recovery unit, above mentioned procedure will be repeated. In between these 2 time points, the procedure may be repeated up to 3 times if a patient “moves” from one pain category into another (4 categories defined: no [NRS 0], mild [NRS 1-3], moderate [NRS 4-5] and severe [NRS 6-10] pain). To identify changes in pain perception, patients are frequently (approx. 5 minutely) asked to rate their pain on the NRS. This is a standard procedure in the Royal Perth Hospital recovery room. Hence, a minimum of 2 and a maximum of 5 blood samples (=20ml) may be taken of a subject. The study period ends with discharge of a patient from the recovery room.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a patient's reported pain score after surgery actually matches measurable changes in their body, specifically stress hormone levels (adrenaline and noradrenaline) and heart rate measurements. It is commonly assumed that pain causes the body to release stress hormones, but this has not been well studied. Researchers will take blood samples and measure heart rate patterns in patients recovering from non-emergency plastic surgery to see if the two line up. You may be eligible if: - You are 18 years or older - You are scheduled for non-emergency minor plastic surgery - You do not have a pacemaker You may NOT be eligible if: - You are under 18 years old - You are unable to give informed consent - You have a pacemaker - You are taking medications that affect heart rate or stress hormones (e.g., ketamine, clonidine) - You have a chronic problem with drug or alcohol use - You require a continuous IV opioid drip for pain Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Assessment of acute pain on a numeric rating scale (NRS 0-10, categories: 0= no pain, 1-3 = mild, 4-5 = moderate, >6 = severe pain) every 5 minutes during a patients stay in the recovery room (as long

Assessment of acute pain on a numeric rating scale (NRS 0-10, categories: 0= no pain, 1-3 = mild, 4-5 = moderate, >6 = severe pain) every 5 minutes during a patients stay in the recovery room (as long as this might take) in the recovery room. In addition, monitoring of blood pressure, respiration rate and heart rate, as well as recording and calculation of Electrocardiogram-based parameters of heart rate variability. At up to 5 time points (admission to the recovery room, discharge from the recovery room + whenever a patient "transits" down a pain category, e.g. from severe to moderate pain, or when a patient "transits" up to any level above "no pain" [no further samples after first "transit up"]) 5 ml blood will be sampled from an intravenous (iv) line sited during the anaesthetic to measure the plasma levels of adrenaline and noradrenaline.


Locations(1)

Australia

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ACTRN12610000454077


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