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一项前瞻性随机研究,旨在分析平衡预预防性镇痛在脊柱手术中的疗效。

A prospective randomized study to analyze the efficacy of balanced pre-emptive analgesia in spine surgery.

机构信息

Department of Spine Surgery, Ganga Hospital, 313, Mettupalayam Rd, Coimbatore, India.

Department of Spine Surgery, Ganga Hospital, 313, Mettupalayam Rd, Coimbatore, India.

出版信息

Spine J. 2019 Apr;19(4):569-577. doi: 10.1016/j.spinee.2018.10.010. Epub 2018 Oct 22.

DOI:10.1016/j.spinee.2018.10.010
PMID:30359764
Abstract

BACKGROUND CONTEXT

Surgical procedures involving the spine are known to cause moderate to severe postoperative pain. Inadequate management of acute pain in the postoperative period results in higher morbidity, and consequently may lead to chronic pain caused by central sensitization. The role of pre-emptive analgesia (PA) and intraoperative analgesia in management of postoperative pain has gained precedence over recent years. Pathophysiology of postoperative pain in spine surgery is unique, as it is a combination of nociceptive, inflammatory, and neuronal stimuli. Blockage of all three stimuli in the perioperative period by pre-emptively administrating a combination of paracetamol (P), ketorolac (K), and pregabalin (PR) might help in adequate management and alleviation of acute postoperative pain.

PURPOSE

To evaluate the analgesic effect of a combination of P, K, and PR as pre-emptive multimodal analgesia, aimed to block or reduce acute postoperative pain after spine surgery.

STUDY DESIGN

A prospective, randomized, controlled, and double-blinded clinical trial.

PATIENT SAMPLE

After Institutional Review Board approval, 100 consecutive patients requiring single- or double level spinal fusion procedures were randomized into two groups-PA and control (C).

METHODS

The PA group received P, K, and PR 4 hours before surgery, as PA. Both groups underwent identical anesthetic and postoperative pain management protocol.

OUTCOME MEASURES

Demographic and surgical data, 4 hourly postoperative pain levels-Numeric Pain Rating scale (NRS), Ambulatory NRS scores; level of consciousness-Ramsay sedation scale, total amount of opioids consumed (TOC) through patient-controlled analgesia; functional levels-Oswestry Disability Index (ODI), surgical satisfaction index-North American Spine Society (NASS) satisfaction scale, duration of hospital stay, and all complications were recorded and analyzed. A research grant of 6,032 USD was obtained from AO Spine toward this work. There is no conflict to disclose.

RESULTS

Both the groups had identical demographic backgrounds and surgical profiles. The average NRS score within the first 48-hour period in the PA group (2.7±0.79) was significantly less than the C group (3.4±0.98) and the differences were more in the first 12 hours following surgery. Similarly, Ambulatory NRS scores were significantly low in the PA group during the first and second postoperative days. The PA group individuals were found to be more physically motivated, as 95.7% were able to ambulate 50 m on the first postoperative day compared with 30% in the C group. The PA group had significantly low TOC (3.02±2.29 mg) in comparison to the C group (4.94±3.08 mg). The duration of hospital stay was 4.17±1.02 and 4.84±1.62 days in the PA and C groups (p=.017), respectively. No major complications occurred in either groups and were found to be similar in percentage between both the groups, except for nausea and vomiting which were more in C group. Dry mouth was the most common side effect noted irrespective of the groups. All patients had significant improvement in ODI with better results in PA group at first month follow up. The PA group (97.90%) was extremely satisfied compared with C group (72%, p=.002) according to NASS scale.

CONCLUSIONS

Postoperative pain management in spine surgery is maximized if perioperative painful stimuli can be inhibited, which requires adequate blood levels of analgesic, anti-inflammatory, and neuropathic drugs intraoperatively. The employed strategy of preoperative administration of balanced analgesia with a combination of P, K, and PR, each having different mechanisms of action, resulted in lesser pain intensity, allowed better ambulation tolerance, improved functional outcomes and has also reduced the requirement of opioids and duration of hospital stay with no additional complications. Thus, this balanced analgesia administered preoperatively would address the complicated postsurgical pain.

摘要

背景

已知涉及脊柱的手术会引起中重度术后疼痛。术后急性疼痛管理不当会导致更高的发病率,进而可能导致中枢敏化引起的慢性疼痛。近年来,预防性镇痛(PA)和术中镇痛在术后疼痛管理中的作用已占据主导地位。脊柱手术后的术后疼痛的病理生理学是独特的,因为它是伤害性、炎症性和神经元刺激的结合。在围手术期通过预先给予对乙酰氨基酚(P)、酮咯酸(K)和普瑞巴林(PR)的组合来阻断所有三种刺激,可能有助于对急性术后疼痛进行充分的管理和缓解。

目的

评估 P、K 和 PR 的组合作为预防性多模式镇痛的镇痛效果,旨在阻断或减轻脊柱手术后的急性术后疼痛。

研究设计

前瞻性、随机、对照、双盲临床试验。

患者样本

在机构审查委员会批准后,100 例连续需要单或双水平脊柱融合手术的患者被随机分为两组-PA 和对照组(C)。

方法

PA 组在手术前 4 小时接受 P、K 和 PR,作为 PA。两组均接受相同的麻醉和术后疼痛管理方案。

结果

两组的人口统计学和手术概况均相同。PA 组在前 48 小时内的平均 NRS 评分(2.7±0.79)明显低于 C 组(3.4±0.98),并且在手术后的前 12 小时内差异更大。同样,PA 组在术后第一天和第二天的 Ambulatory NRS 评分明显较低。PA 组的个体更有体力,因为 95.7%的个体能够在术后第一天行走 50 米,而 C 组只有 30%。PA 组的 TOC(3.02±2.29 毫克)明显低于 C 组(4.94±3.08 毫克)。PA 组的住院时间为 4.17±1.02 天,C 组为 4.84±1.62 天(p=.017)。两组均未发生重大并发症,且两组的发生率相似,除了 C 组恶心和呕吐更为常见。口干是无论在哪个组中最常见的副作用。所有患者的 ODI 均有显著改善,PA 组在第一个月随访时的结果更好。根据 NASS 量表,PA 组(97.90%)非常满意,而 C 组(72%,p=.002)满意。

结论

如果可以抑制围手术期的疼痛刺激,则可以最大程度地管理脊柱手术的术后疼痛,这需要术中给予足够的镇痛、抗炎和神经病理性药物的血液水平。采用术前给予平衡镇痛的策略,结合对乙酰氨基酚、酮咯酸和普瑞巴林,每种药物都有不同的作用机制,结果疼痛强度减轻,更好地耐受行走,改善了功能结果,减少了对阿片类药物的需求和住院时间,且无额外并发症。因此,这种术前给予的平衡镇痛可以解决复杂的术后疼痛。

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