Pre- vs. Post-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Orthopedic Oncologic Patients: A Comparative, Randomized, Double Blind Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the beneficial effects of PGL administered either pre-incisionally or post-incisionally on the immediate and late (1- and 3 months) postoperative analgesia requirements and pain scores
研究概览
简要总结
Hypothesis
No studies considered the comparison of preemptive vs. post-surgery Pregabalin (PGL) only administration. The investigators believe that the administration of PGL preemptively would diminish pain sensation and therefore the need for opioids administration in orthopedic-oncologic patients more effectively than if administered starting postoperatively.
详细描述
Background
Proper pain relief is a major concern of patients worldwide. Pain concerns the surgical team as well, because of its correlation with clinical outcomes and patients' satisfaction rate. Studies have shown that negative clinical outcome with regard to pain control includes decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension, myocardial ischemia, transition into chronic pain, poor wound healing, and psychological sequelae. Pain has been found to be one of the three most common medical causes of delayed/aborted discharge after ambulatory surgery, the other two being drowsiness and postoperative nausea/vomiting. Despite progress that has been made with regard to postoperative pain control, and the development of new standards for pain control, many patients continue to experience intense pain after surgery.
Recent advances in the understanding of the particularities of central sensitization indicate that it plays an important role in post surgical and post traumatic pain and therefore should be avoided. We now distinguish postoperative pain, which is mostly nociceptive, and which perceives pain following surgical insult, from the exacerbation of acute nociceptive pain that leads to neural sensitization, when sensations that are not normally painful, are perceived as painful, as in hyperalgesia and allodynia. Thus, acute pain may transform into subacute or chronic pain, conditions that are harder to control when more persistent (chronic) they become. Better pain control, possibly using drugs that affect both acute and chronic pains, seems therefore the current optimal choice.
Multimodal analgesia Advances in knowledge of the neuropharmacological molecular mechanisms of pain have led to the development of "multimodal analgesia" practice.
The concept of multimodal analgesia is now a well established clinical practice. For example, non-steroidal anti-inflammatory medications combined with intravenous patient-controlled morphine administration, may decrease nausea and sedation in patients when compared with that using patient-controlled morphine analgesia alone. Multimodal analgesia also can produce opioid sparing effects. Our group has shown repeatedly, that multimodal analgesia spares postoperative morphine consumption and increases level of patients' satisfaction. However, they may not improve postoperative outcome in terms of faster recovery, reduced hospital stay, and decreased length of convalescence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III patients who will undergo bone with or without soft tissue cancer surgery type II and III [24,25] under general or epidural anesthesia in Tel-aviv Sourasky Medical Center will be enrolled to this study that will be approved by our institutional human research and ethics committee.
- •All participants will sign a Helsinki-approved informed consent, and will be given full explanation of the drug, PCA and the numerical rating scale (NRS) during the pre-anesthesia interview.
排除标准
- •These will include allergy to opioids, bupivacaine, midazolam, PGL, or non-steroidal anti-inflammatory drugs (NSAIDs), a history of chronic pain or psychiatric disorders and the use of centrally acting drugs of any sort. Patients <18 or >80 years, soldiers and pregnant women will also be excluded from the study.
研究组 & 干预措施
IV-PCA (Patient-controlled analgesia) morphine
干预措施: Pregabalin (Drug)
Patient controlled epidural analgesia (PCEA) fentanyl
干预措施: Pregabalin (Drug)
结局指标
主要结局
To assess the beneficial effects of PGL administered either pre-incisionally or post-incisionally on the immediate and late (1- and 3 months) postoperative analgesia requirements and pain scores
时间窗: 2 years
In the PACU (post-anesthesia care unit), the parameters (pain, sedation, feeling of anxiety, total morphine, fentanyl, and bupivacaine consumptions, PCA activation, antinociceptives PO/IV, overall maximal pain intensity throughout the study period) will be assessed by the attending physician every 15 min for the first postoperative hour and every 30 min thereafter. On the ward, vital signs will be recorded Q 8 h.
次要结局
未报告次要终点