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Effect of Intraoperative Multimodal Analgesia on the Early Postoperative Quality of Recovery in End-stage Head and Neck Cancer Patients Undergoing Open Gastrostomy: A Prospective Randomized Controlled Study
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摘要:
目的 评估术中多模式镇痛在终末期头颈部癌症患者开腹胃造瘘术后早期恢复中的作用。 方法 本研究为前瞻性、平行、随机对照研究，研究对象为2022年11月—2023年5月首都医科大学附属北京同仁医院择期行开腹胃造瘘术的终末期头颈部癌症患者。按1∶1比例随机将其分为局麻组和多模式镇痛组。局麻组术中予以0.25%罗哌卡因20~30 mL局部浸润麻醉；多模式镇痛组麻醉方式为神经阻滞+静脉镇痛：在超声引导下行左侧腹横肌平面阻滞(0.25%罗哌卡因0.3 mL/kg)+双侧腹直肌鞘阻滞(每侧注射0.25%罗哌卡因0.3 mL/kg)+静脉注射羟考酮0.1 mg/kg、氟比洛芬酯1 mg/kg和地塞米松0.2 mg/kg。主要结局指标为术后24 h 15项恢复质量量表(quality of requirements-15, QoR-15)评分，次要结局指标为术后48 h QoR-15评分，术后不同时间点静息时与运动时疼痛数字评定量表(numerical rating scale, NRS)评分和Bruggemann舒适量表(Bruggrmann comfort scale, BCS)评分，术后首次补救镇痛时间，首次下床活动时间，首次排气时间及术后48 h内不良反应发生率。 结果 最终入选符合纳入与排除标准的行开腹胃造瘘术终末期头颈部癌症患者46例，其中多模式镇痛组、局麻组均为23例。两组术前QoR-15评分差异无统计学意义(P＞0.05)，多模式镇痛组术后24 h[(81.77±8.91)分比(71.46±7.61)分, P＜0.05]、48 h[(86.26±7.92)分比(80.13±6.98)分, P＜0.05]QoR-15评分均高于局麻组，且术后24 h QoR-15评分差异具有临床意义。与局麻组比较，术后6 h、24 h时，多模式镇痛组静息时与运动时NRS评分降低，舒适度BCS评分升高(P均＜0.05)。相较于局麻组，多模式镇痛组术后首次补救镇痛时间延后，术后48 h内补救镇痛发生率降低，术后首次下床活动时间与术后首次排气时间均提前(P均＜0.05)。多模式镇痛组、局麻组不良反应发生率分别为8.70%、13.04%，差异无统计学意义(P＞0.05)。 结论 术中多模式镇痛可减轻开腹胃造瘘术患者术后早期疼痛，提高舒适度，缩短术后下床活动时间和排气时间，继而提升术后早期恢复质量。 Abstract:Objective To evaluate the effect of intraoperative multimodal analgesia on the early postoperative quality of recovery in end-stage head and neck cancer patients undergoing open gastrostomy surgery. Methods This was a prospective, parallel, randomized controlled study. The research subjects were end-stage head and neck cancer patients who underwent elective open gastrostomy at Beijing Tongren Hospital affiliated to Capital Medical University from November 2022 to May 2023. The patients were randomly divided into local anesthesia group and multimodal analgesia group at a 1∶1 ratio. For local anesthesia group, 0.25% ropivacaine 20-30 mL was administered for local infiltration anesthesia. For multimodal analgesia group, the anesthesia method was nerve block + intravenous analgesia: ultrasound-guided left transverse abdominis plane block (0.25% ropivacaine 0.3 mL/kg)+bilateral rectus abdominis sheath block (0.25% ropivacaine 0.3 mL/kg per side)+intravenous injection of oxycodone 0.1 mg/kg, flurbiprofen 1 mg/kg, and dexamethasone 0.2 mg/kg. The primary outcome measure was the quality of requirements-15 (QoR-15) score at postoperative 24 h, while the secondary outcome measures were the QoR-15 score at postoperative 48 h, the numerical rating scale (NRS) and Bruggemann comfort scale (BCS) scores at different time points after the surgery, the first time of rescue analgesia, the first time of off-bed activity and intestinal exhaust, as well as the incidences of adverse reactions within postoperative 48 h. Results A total of 46 patients with end-stage head and neck cancer who underwent open gastrostomy and met the inclusion and exclusion criteria were ultimately enrolled, with 23 patients in multimodal analgesia group and 23 patients in local anesthesia group. There was no statistically significant difference in preoperative QoR-15 scores between the two groups (P > 0.05). Multimodal analgesia group had higher QoR-15 scores at 24 h postoperatively[(81.77±8.91) vs. (71.46±7.61), P < 0.05] and 48 h postoperatively[(86.26±7.92) vs. (80.13±6.98), P < 0.05], and the difference in QoR-15 scores at 24 h postoperatively was clinically significant. Compared with local anesthesia group, at 6 h and 24 h after surgery, the multimodal analgesia group showed a decrease in NRS scores at rest and during exercise, while the comfort BCS score increased (all P < 0.05). Multimodal analgesia group also had a delayed time for the first rescue analgesia, a reduced incidence of rescue analgesia within 48 h after surgery, an earlier time for first postoperative off-bed activity and intestinal exhaust (all P < 0.05). The incidence of adverse reactions in multimodal analgesia group and local anesthesia group was 8.70% and 13.04%, respectively, but the difference was not statistically significant (P > 0.05). Conclusion Intraoperative multimodal analgesia can effectively alleviate postoperative pain, increase the comfortable degree, shorten the first time of postoperative off-bed activity and intestinal exhaust, and accordingly improve the quality of early postoperative recovery in patients undergoing open gastrostomy. 作者贡献：胡春华负责病例收集、数据分析、论文初稿撰写；赵晓艳负责数据分析结果复核、文献查阅；吴黎黎、陈红芽、许鑫负责病例收集；王古岩负责研究设计及论文修订。利益冲突：所有作者均声明不存在利益冲突 -
表 1 两组患者一般临床资料比较
Table 1. Comparison of general data in two groups
组别 年龄
(x±s，岁)性别
(男/女，例)BMI
(x±s，kg/m2)ASA分级
(Ⅲ/Ⅳ，例)手术时间
(x±s，min)术中失血量
(x±s，mL)术中输液量
(x±s, mL)多模式镇痛组(n=23) 60.1±7.9 18/5 18.26±3.17 17/6 51.21±10.11 10.50±5.31 731.15±95.64 局麻组(n=23) 59.8±9.9 20/3 19.09±4.01 14/9 53.88±10.54 11.66±7.09 826.67±91.24 P值 0.316 0.697 0.358 0.345 0.698 0.883 0.209 BMI(body mass index)：体质量指数；ASA(American Society of Aneshesiologists)：美国麻醉医师协会 
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表 2 两组手术前后QoR-15评分比较(x±s，分)
Table 2. Comparison of QoR-15 scores before and after surgery in two groups(x±s, scores)
组别 术前 术后24 h 术后48 h 多模式镇痛组(n=23) 98.16±6.33 81.77±8.91# 86.26±7.92# 局麻组(n=23) 99.11±8.28 71.46±7.61*# 80.13±6.98*# QoR-15(quality of requirements-15)：15项恢复质量量表；*组间比较差异具有统计学意义(P＜0.05)，#组内与术前比较差异具有统计学意义(P＜0.05)
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表 3 两组术后NRS评分比较(x±s，分)
Table 3. Comparison of postoperative NRS scores in two groups (x±s, scores)
组别 术后6 h 术后24 h 术后48 h 多模式镇痛组(n=23) 静息时 1.3±0.6* 3.6±0.6* 3.1±0.7 运动时 1.7±0.5* 4.1±0.4*# 3.7±0.6# 局麻组(n=23) 静息时 2.9±0.5 4.0±0.5 3.2±0.6 运动时 4.7±0.7# 4.6±0.6# 4.0±0.5# NRS(numerical rating scale)：数字评定量表；*组间比较差异具有统计学意义(P＜0.05)；#组内同时间不同状态NRS评分比较具有统计学意义(P＜0.05)
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表 4 两组术后BCS评分比较(x±s，分)
Table 4. Comparison of postoperative BCS scores in two groups (x±s, scores)
组别 术后6 h 术后24 h 术后48 h 多模式镇痛组(n=23) 3.8±0.6* 1.8±0.5*# 2.3±0.6# 局麻组(n=23) 0.9±0.3 1.2±0.3# 2.2±0.5# BCS(Bruggrmann comfort scale)：Bruggemann舒适量表；*组间比较差异具有统计学意义(P＜0.05)；#与组内术后6 h比较，BCS评分差异具有统计学意义(P＜0.05)
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