Yano Takaaki, Ihara Yasutaka, Yoshida Hisako, Imai Takumi, Kawai Ryota, Shintani Ayumi
Yano Komon Geka Clinic, Takamatsu, Japan.
Department of Medical Statistics, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan.
J Anus Rectum Colon. 2024 Jul 30;8(3):221-227. doi: 10.23922/jarc.2024-002. eCollection 2024.
Excisional hemorrhoidectomy (EH) is sometimes same-day surgery under local anesthesia (LA); however, the LA injection can be painful. We conducted an open-label, crossover, randomised controlled trial to evaluate the efficacy and safety of pre-cooling in reducing pain associated with LA injection.
Patients aged ≥ 20 years undergoing bilateral EH were randomly assigned to 1 of 2 pre-cooling sequences: a cooling-first sequence and a cooling-second sequence. In the first intervention phase, 2 minutes of pre-cooling was applied before LA injection in patients randomized to the cooling-first sequence; patients in the cooling-second sequence were asked to wait for 2 minutes (without pre-cooling) before LA injection. The pre-cooling sequences and the perianal sides targeted for injection were reversed in the second intervention phase. The primary outcome was the visual analogue scale (VAS) rating for pain from LA injection, which was obtained twice for each patient. Adverse events due to pre-cooling (e.g., skin disorders) were documented.
Of 114 screened patients, 51 were randomized to the cooling-first (n = 26; analyzed: n = 26) or cooling-second sequence (n = 25; analyzed: n = 25). The 2-minute pre-cooling was completed by 48 patients (94%). VAS scores for LA injection pain decreased significantly with pre-cooling compared to without (difference estimate, -1.71; 95% confidence interval, -2.12 to -1.31; p< 0.001). No adverse events were reported.
Two minutes of skin pre-cooling effectively and safely reduces LA injection pain in patients undergoing EH.
痔切除术（EH）有时是在局部麻醉（LA）下进行的当日手术；然而，局部麻醉注射可能会很疼。我们进行了一项开放标签、交叉、随机对照试验，以评估预冷在减轻局部麻醉注射相关疼痛方面的疗效和安全性。
年龄≥20岁且接受双侧痔切除术的患者被随机分配到2种预冷顺序中的1种：先冷却顺序和后冷却顺序。在第一个干预阶段，随机分配到先冷却顺序的患者在局部麻醉注射前进行2分钟预冷；后冷却顺序的患者在局部麻醉注射前被要求等待2分钟（不进行预冷）。在第二个干预阶段，预冷顺序和注射的肛周部位互换。主要结局是局部麻醉注射疼痛的视觉模拟量表（VAS）评分，每位患者获取两次该评分。记录预冷引起的不良事件（如皮肤疾病）。
在114名筛查患者中，51名被随机分配到先冷却组（n = 26；分析：n = 26）或后冷却组（n = 25；分析：n = 25）。48名患者（94%）完成了2分钟预冷。与未预冷相比，预冷后局部麻醉注射疼痛的VAS评分显著降低（差异估计值，-1.71；95%置信区间，-2.12至-1.31；p < 0.001）。未报告不良事件。
两分钟的皮肤预冷可有效且安全地减轻接受痔切除术患者的局部麻醉注射疼痛。
