Vijapurkar Swati, Ramchandani Sarita, Ramchandani Radhakrishna, Singha Subrata K, Kumar Mayank
Anaesthesiology, All India Institute of Medical Sciences, Raipur, Raipur, IND.
General Surgery, All India Institute of Medical Sciences, Raipur, Raipur, IND.
Cureus. 2024 Dec 21;16(12):e76124. doi: 10.7759/cureus.76124. eCollection 2024 Dec.
Breast cancer is the most common cancer in females. Surgery is the gold standard therapy, with modified radical mastectomy (MRM) being the most commonly performed procedure for breast cancer. Management of postoperative pain after MRM poses a clinical challenge and hence receives utmost priority. Ultrasound-guided regional nerve blocks are commonly administered to combat post-surgical pain after MRM. In this context, retrolaminar block (RLB) and erector spinae plane block (ESPB) are relatively newer techniques. Though these blocks are quicker, safer, and easier to administer, very few studies have been done to compare their postoperative analgesic efficacy. Henceforth, we conducted this trial to compare the postoperative analgesic efficacy of ESPB and RLB in patients scheduled for MRM.
The procedures followed in this trial were according to the norms of the Declaration of Helsinki (2013). The study was started after obtaining approval from the Institutional Ethics Committee (IEC), written informed consent from the patients, and trial registration in the Clinical Trials Registry of India. Sixty female patients of the American Society of Anesthesiologists with physical statuses 1, 2, and 3, aged 18 years and above, planned for unilateral MRM under general anesthesia, were included, whereas patients not giving consent, allergic to study drugs, having contraindications to regional anesthesia, with a body mass index (BMI) of ≥ 35 kg/m, deformity of the spine, psychiatric illness, lactating, or pregnant women were excluded. Computer-generated randomization was used to allocate the patients to groups E and R to receive ESPB or RLB, respectively, using 30 mL of ropivacaine (0.5%) with 2 mL of dexamethasone at the T4 spinous process level under ultrasound guidance. The primary outcome was to determine the time to rescue analgesia based on a visual analog scale score ≥ 4. Secondary objectives were the intraoperative fentanyl consumption and side effects (if any).
Sixty participants completed the study. Both groups were comparable in terms of demographic parameters, duration of surgery, time to the first dose of rescue analgesia, intraoperative fentanyl consumption, and side effects. The mean (SD) of duration of surgery (minutes) was 202.33 (14.55) and 197.00 (18.60) with P = 0.134, time to rescue analgesia (minutes) was 425.67 (134.33) and 468.50 (142.74) with P = 0.236, and intraoperative fentanyl consumption (mcg) was 4.00 (11.02) and 4.67 (8.60) with P = 0.410 in Group E and R, respectively.
Both groups were similar in terms of the time to rescue analgesia, fentanyl consumption intraoperatively, and side effects. Thus, the ESPB is comparable to and not better than RLB for providing postoperative analgesia in patients with carcinoma breast undergoing MRM.
乳腺癌是女性最常见的癌症。手术是金标准治疗方法,改良根治性乳房切除术(MRM)是最常用于治疗乳腺癌的手术。MRM术后疼痛的管理构成了一项临床挑战,因此被置于最优先考虑的地位。超声引导下区域神经阻滞常用于对抗MRM术后的疼痛。在此背景下,椎板后阻滞(RLB)和竖脊肌平面阻滞(ESPB)是相对较新的技术。尽管这些阻滞操作更快、更安全且更易于实施,但很少有研究对它们的术后镇痛效果进行比较。因此,我们开展了这项试验,以比较ESPB和RLB在计划接受MRM的患者中的术后镇痛效果。
本试验遵循的程序符合《赫尔辛基宣言》(2013年)的规范。在获得机构伦理委员会(IEC)的批准、患者的书面知情同意以及在印度临床试验注册中心进行试验注册后,研究开始。纳入60例年龄18岁及以上、美国麻醉医师协会身体状况分级为1、2和3级、计划在全身麻醉下接受单侧MRM的女性患者,而未给予同意、对研究药物过敏、有区域麻醉禁忌证、体重指数(BMI)≥35kg/m²、脊柱畸形、患有精神疾病、正在哺乳或怀孕的女性被排除。采用计算机生成的随机化方法将患者分配到E组和R组,分别接受ESPB或RLB,在超声引导下于T4棘突水平使用30mL罗哌卡因(0.5%)加2mL地塞米松。主要结局是根据视觉模拟量表评分≥4确定补救性镇痛的时间。次要目标是术中芬太尼用量和副作用(如有)。
60名参与者完成了研究。两组在人口统计学参数、手术持续时间、首次给予补救性镇痛的时间、术中芬太尼用量和副作用方面具有可比性。E组和R组手术持续时间(分钟)的均值(标准差)分别为202.33(14.55)和197.00(18.60),P = 0.134;补救性镇痛时间(分钟)分别为425.67(134.33)和468.50(142.74),P = 0.236;术中芬太尼用量(微克)分别为4.00(11.02)和4.67(8.60),P = 0.410。
两组在补救性镇痛时间、术中芬太尼用量和副作用方面相似。因此,对于接受MRM的乳腺癌患者,ESPB在提供术后镇痛方面与RLB相当,并不优于RLB。