Does Pain Reporting Accuracy Relates to the Intensity of Acute Post-operative Pain and Analgesic Drug Consumption?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in acute post-operative pain throughout the hospitalization period
研究概览
简要总结
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.
详细描述
Objectives and hypotheses: The purpose of this study is to examine whether pain reporting accuracy (as examined in the FAST test) predicts the intensity of acute post-operative pain and the consumption of pain-relieving drugs. The investigators hypothesize that the more accurate a person is in his pain reports, the more likely he will be to correlate postoperative pain and Analgesic drugs consumption.
The study population: The sample will include 40 subjects (men and women) who are about to undergo elective head & neck surgery in the Department of Otolaryngology.
Study design:
The institutional ethics committee of Carmel Medical Center approved the study protocol in accordance with the Helsinki Declaration, and written consent will be obtained from each subject before the beginning of the experiment. Participants will be enrolled into the study after meeting the inclusion criteria. The experiment will consist of one session, which will last about 45 minutes, during which the subject will undergo brief familiarization with the device, the stimulation and the scale in the study. Thereafter, all subjects will undergo the FAST procedure. Between the familiarization and the FAST, the subject will fill out pain-related personality questionnaires. From the moment of returning to the department after the surgery, the clinical follow-up will begin following pain reports and the consumption of pain-relieving drugs until the patient is released.
Psychophysical assessment: The contact-heat Q-sense system (Medoc, Ramat-Yishai, Israel) will be used to deliver the tonic heat stimulations applied by a 30 x 30 mm Peltier surface stimulator, which will be attached by Velcro straps to the volar surface of the forearm of the subject hand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Candidates to Head & Neck elective surgery
排除标准
- •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.
结局指标
主要结局
Change in acute post-operative pain throughout the hospitalization period
时间窗: 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.
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".
Amount of analgesic drugs consumption I
时间窗: From post-surgery recovery until discharge (24-48 hours after surgery)
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.
次要结局
- Amount of analgesic drugs consumption II(From post-surgery recovery until discharge (24-48 hours after surgery))
- Amount of analgesic drugs consumption III(From post-surgery recovery until discharge (24-48 hours after surgery))
研究者
Tal Honigman
Principal Investigator
Carmel Medical Center