■开颅手术后的疼痛仍然是一个控制不佳的问题,主要是由切口部位的炎症反应引起的。如今,全身使用阿片类药物,作为一线镇痛药,通常由于不利影响而受到限制。氟比洛芬酯(FA)是一种非甾体类抗炎药,融合为乳化脂质微球,这代表了对炎性病变的强烈亲和力。将氟比洛芬局部施用到手术伤口中已经诱导了增强的镇痛功效,并且在口腔手术后几乎没有全身或局部副作用。然而,当地FA的影响,作为一种非阿片类药物替代药物,在开颅手术中,术后疼痛仍然难以捉摸。在这项研究中,我们推测,与单独使用罗哌卡因相比,在患者静脉自控镇痛(PCIA)中,以FA作为罗哌卡因辅助的头皮抢先浸润可导致术后舒芬太尼消耗量减少.
■我们设计了一个多中心,随机对照研究将纳入216名计划接受幕上开颅手术的受试者。患者将接受50mgFA和0.5%罗哌卡因的头皮预先浸润,或单独使用0.5%罗哌卡因。主要结果是术后48小时使用PCIA装置的舒芬太尼的总消耗量。
■这是第一个试图探索局部FA作为罗哌卡因辅助治疗开颅手术患者切口疼痛的镇痛和安全性的研究。通过在神经外科手术中局部施用NSAIDs,它将为阿片类药物的镇痛途径提供更多见解。
UNASSIGNED: Pain after craniotomy remains a poorly controlled problem that is mainly caused by the inflammatory reaction at the incision site. Nowadays, systemic opioids use, as first-line analgesics, is often limited because of adverse effects. Flurbiprofen axetil (FA) is a non-steroidal anti-inflammatory drug merged into emulsified lipid microspheres, which represent a strong affinity to inflammatory lesions. Local administration of flurbiprofen into a surgical wound has induced enhanced analgesic efficacy and few systemic or local adverse effects after oral surgery. However, the impact of local FA, as a non-opioid pharmacologic alternative, remains elusive on postoperative pain in craniotomy. In this study, we presume that pre-emptive infiltration of scalp with FA as an adjuvant to ropivacaine can lead to less sufentanil consumption postoperatively in patient controlled intravenous analgesia (PCIA) compared with ropivacaine alone.
UNASSIGNED: We design a multicenter, randomized controlled study that will enroll 216 subjects who are planned to receive supratentorial craniotomy. Patients will receive pre-emptive infiltration of scalp either with 50 mg FA and 0.5% ropivacaine, or with 0.5% ropivacaine alone. Primary outcome is total consumption of sufentanil with PCIA device at 48 h postoperatively.
UNASSIGNED: This is the first study attempting to explore the analgesic and safety profile of local FA as an adjuvant to ropivacaine for incisional pain in patients undergoing craniotomy. It will provide additional insights into the opioid-sparing analgesia pathways by local administration of NSAIDs for neurosurgery.