Psychosocial and Psychophysical Factors Influencing the Effect of Preemptive Systemic Analgesia in Combination With Regional Anesthesia on Postoperative Pain Following Upper Limb Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Opioid consumption in the first 24 hours
研究概览
简要总结
The purpose of this study is to define the role of preemptive systemic analgesia in combination with regional anesthetic techniques on postoperative pain following upper limb surgery in different subgroups of patients with different psychosocial and psychophysical characteristics.
详细描述
After being informed about the study and potential risks, patients will be given written informed consent. The study will include patients between the ages of 18 and 65, rated 1 or 2 by the American Society of Anesthesiologists (ASA) classification scheduled for distal radius surgery.
We will exclude patients with a known allergy to or adverse reaction to a local anesthetic, opioid, paracetamol or non-steroidal anti-inflammatory drugs, patients with a known opioid dependence, injection site infection, chronic pain, renal disease, known neuropathy, liver disease, with psychiatric disorders and diabetics.
The study will be randomized, prospective and double-blind. We will study the effect of preemptive dose of paracetamol and ibuprofen and pregabalin on postoperative pain after distal radius surgery in patients with different psychosocial and psychophysical characteristics. Patients will be admitted to the ward the day before surgery. At that time, we will explain to them the course of the research and offer them participation. For those with a written consent we will perform preoperative quantitative sensory tests on the same day and give them pain questionnaires.
We will determine conditional pain modulation by first applying a mechanical test stimulus of increasing intensity with an algometer to the skin of the volar side of the forearm and the skin in the middle of the front of the thigh contralateral to the injury until the patient experiences pain on the visual analog scale (VAS) 4/10. At that point the patients will press the patient operated button on the algometer and the stimulus will be stopped with the measurement stored. We will then repeat the same test together with a conditional stimulus - immersion of the ipsilateral lower extremity in cold water at 2 degrees Celsius. Conditional pain modulation will be calculated by subtracting the intensity of the independent primary stimulus from the intensity of the primary stimulus together with a concomitant conditioned stimulus. The end result will be the average of the values obtained on the skin of the volar side of the forearm and the skin in the middle of the front of the thigh.
On the same day the patients will also complete a Pain Catastrophising Scale (PCS) Questionnaire and a Brief Pain Inventory (BPI). They will also receive a short questionnaire to assess the pain and quality of sleep on the first night after surgery, which they will complete together with an anesthesiologist the morning after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will receive either the actual drug or placebo. A separate investigator will be in charge of preparing the capsules and intravenous solutions that patients will receive before surgery in a way that it will not be possible to determine whether it is an actual drug or a placebo. That investigator will also write in which group the patient is on a piece of paper and insert it in the patient's inventory for safety purposes. The person that will measure the conditioned pain modulation and complete the pain questionnaires with patients will be a separate investigator. The anesthesiologist performing the axillary block will also be blinded, because the drugs/placebo will be prepared by a separate investigator. We will code the group to which the patients are allocated, so that the Outcomes Assessor will also be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) classification score 1 and 2
- •Patients with a distal radius fracture, scheduled for surgery
排除标准
- •Allergy to a local anesthetic, opioid, paracetamol or a non-steroidal antirheumatic drug
- •Opioid addiction
- •Infection at the injection site
- •Chronic pain syndromes
- •Neuropathies
- •Liver cirrhosis
- •Chronic kidney disease stage 3 or higher
- •Psychiatric illness
研究组 & 干预措施
Paracetamol and Ibuprofen
Patients will receive a placebo capsule in the hour before surgery and an intravenous dose of paracetamol 1 g and ibuprofen 400 mg before surgical incision.
干预措施: Paracetamol and Ibuprofen (Combination Product)
Placebo
Patients will receive a placebo capsule in the hour before surgery and two intravenous doses of saline before surgical incision.
干预措施: Placebo (Drug)
Pregabalin
Patients will receive pregabalin 150 mg in the hour before surgery and two intravenous doses of saline before surgical incision.
干预措施: Pregabalin 150mg (Drug)
结局指标
主要结局
Opioid consumption in the first 24 hours
时间窗: First 24 hours, starting at time of surgery
Piritramide consumption will be obtained from the PCA pumb, manual boluses will be added.
Worst pain in the first 24 hours
时间窗: First 24 hours, starting at time of surgery
Worst pain in the first 24 hours after surgery on the visual analog scale (VAS) will be obtained the day after surgery
次要结局
- The incidence of chronic pain(Three months after surgery)
- Sleep quality on the night after surgery(First 24 hours, starting at time of surgery)
- Opioid consumption in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)(First 24 hours, starting at time of surgery)
- Worst pain in the first 24 hours in correlation with preoperative Pain catastrophising scale (PCS)(First 24 hours, starting at time of surgery)
- Opioid consumption in the first 24 hours in correlation with preoperative Conditioned pain modulation (CPM)(First 24 hours, starting at time of surgery)
- Worst pain in the first 24 hours in correlation with preoperative Conditioned pain modulation (CPM)(First 24 hours, starting at time of surgery)
- The incidence of chronic pain in correlation with preoperative Conditioned pain modulation (CPM)(3 months after surgery)
- The incidence of chronic pain in correlation with preoperative Pain catastrophising scale (PCS)(3 months after surgery)
研究者
Benjamin Jonke
Doctor of Medicine
University Medical Centre Ljubljana