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头颈部癌症患者术后应用持续局部麻醉剂伤口灌洗的疼痛治疗:一项非随机临床试验。

Postoperative Pain Treatment With Continuous Local Anesthetic Wound Infusion in Patients With Head and Neck Cancer: A Nonrandomized Clinical Trial.

机构信息

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Cologne, Cologne, Germany.

Department of Otorhinolaryngology-Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany.

出版信息

JAMA Otolaryngol Head Neck Surg. 2021 Jun 1;147(6):553-560. doi: 10.1001/jamaoto.2021.0327.

Abstract

IMPORTANCE

Up to 80% of patients with head and neck cancer undergoing ablative surgery and neck dissection develop postoperative pain with detrimental effects on quality of life that also contributes to neuropathic and chronic postoperative pain.

OBJECTIVE

To investigate the association of continuous local anesthetic wound infusion with pain management after head and neck surgery.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, longitudinal, nonrandomized clinical study carried out in a single tertiary referral center (December 1, 2015, to July 1, 2017) included 2 groups of 30 patients. Patients were consecutively enrolled and presented for ablative head and neck surgery including selective neck dissection and studied from the preoperative through the fourth postoperative day.

INTERVENTIONS

The control group was treated according to a standardized escalating oral treatment protocol (ibuprofen, metamizole, opioids). The intervention group was treated with an intraoperatively applied pain catheter (InfiltraLong plus FuserPump, Pajunk, ropivacaine, 0.2%, 3 mL/h) that was removed 72 hours after operating.

MAIN OUTCOMES AND MEASURES

Average and maximum pain intensities on a numeric rating scale; quality of life using the acute version of the validated 36-Item Short Form Survey; and neuropathic pain using the validated 12-Item painDETECT questionnaire. Consumption of opioid and nonopioid analgesics and evaluation of catheter-associated complications.

RESULTS

During postoperative days 1 through 4, patients of the intervention group (mean [SD] age, 63.2 [13.3 years; 9 [30%] women) experienced lower mean (SD) (1.6 [1.4] vs 2.7 [1.8]; η2p = 0.09 [0.01-0.21]) and maximum (2.4 [2.2] vs 4.2 [2.0]; η2p = 0.11 [0.01-0.24]) pain intensities compared with the control group (mean [SD] age, 62.5 [13.6] years; 5 [17%] women). The intervention group also reported less neuropathic pain (mean [SD], 5.4 [3.4] vs 7.6 [5.1]; η2p = 0.09 [0.004 - 0.22]) and higher quality of life regarding vitality (56.2 [21.5] vs 43.8 [20.9], r = 0.29; 95% CI, 0.01-0.52) and pain (66.8 [27.3] vs 49.5  [27.7], r = 0.31; 95% CI, 0.04-0.54). Patients from the intervention group requested nonopioid analgesics considerably less often (n = 17 [57% ]vs n = 29 [97%]; ϕ = 0.47; 95% CI, 0.30-0.67) associated with a noticeably lower need to escalate pain treatment (n = 3 [10%] vs n = 9 [30%]; mean [SD] ibuprofen dose: 500 [173] mg vs 1133 [650] mg; r = 0.64; 95% CI, 0.02-0.91). No catheter-associated complications were observed.

CONCLUSIONS AND RELEVANCE

Continuous anesthetic wound infusion is associated with reduced postoperative pain and decreased demand for analgesics. It therefore expands the treatment options for postoperative pain in head and neck cancer.

TRIAL REGISTRATION

German Clinical Trials Register: DRKS00009378.

摘要

重要性

多达 80%接受头颈部癌症切除术和颈部解剖术的患者会出现术后疼痛,这对生活质量产生不利影响,并且还会导致神经性和慢性术后疼痛。

目的

研究局部麻醉剂持续伤口输注与头颈部手术后疼痛管理的关系。

设计、地点和参与者:这是一项前瞻性、纵向、非随机的临床研究,在一个单一的三级转诊中心进行(2015 年 12 月 1 日至 2017 年 7 月 1 日),包括 2 组各 30 名患者。连续纳入患者,并进行头颈部切除术,包括选择性颈部解剖术,并在术前至术后第 4 天进行研究。

干预措施

对照组根据标准化递增口服治疗方案(布洛芬、甲灭酸、阿片类药物)进行治疗。干预组使用术中应用的疼痛导管(InfiltraLong plus FuserPump,Pajunk,罗哌卡因,0.2%,3mL/h)进行治疗,在术后 72 小时后取出。

主要结局和测量指标

数字评分量表上的平均和最大疼痛强度;使用经过验证的 36 项简短健康调查的急性版本评估生活质量;使用经过验证的 12 项疼痛 DETECT 问卷评估神经性疼痛。评估阿片类药物和非阿片类药物的镇痛药物的消耗量和导管相关并发症。

结果

在术后第 1 天至第 4 天期间,干预组患者(平均[标准差]年龄,63.2[13.3]岁;9[30%]名女性)的平均(1.6[1.4]比 2.7[1.8];η 2p=0.09[0.01-0.21])和最大(2.4[2.2]比 4.2[2.0];η 2p=0.11[0.01-0.24])疼痛强度明显低于对照组(平均[标准差]年龄,62.5[13.6]岁;5[17%]名女性)。干预组也报告了较少的神经性疼痛(平均[标准差],5.4[3.4]比 7.6[5.1];η 2p=0.09[0.004-0.22])和更高的生活质量,在活力方面(56.2[21.5]比 43.8[20.9],r=0.29;95%置信区间,0.01-0.52)和疼痛(66.8[27.3]比 49.5[27.7],r=0.31;95%置信区间,0.04-0.54)。干预组患者请求非阿片类镇痛药的频率明显较低(n=17[57%]比 n=29[97%];φ=0.47;95%置信区间,0.30-0.67),需要明显减少疼痛治疗的升级(n=3[10%]比 n=9[30%];布洛芬剂量平均[标准差]:500[173]mg 比 1133[650]mg;r=0.64;95%置信区间,0.02-0.91)。未观察到导管相关并发症。

结论和相关性

连续麻醉剂伤口输注与术后疼痛减轻和镇痛药需求减少有关。因此,它扩大了头颈部癌症术后疼痛的治疗选择。

试验注册

德国临床试验注册中心:DRKS00009378。

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