Protocol of a clinical trial on the effectiveness of pudendal nerve block with and without neurostimulation in reducing posthemorroidectomy pain

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Abstract

Introduction

Hemorrhoidal pathology is the most frequent proctological problem with a prevalence of 44% of the adult population. The most effective treatment is surgery but it also has the highest postoperative pain rate with moderate to severe pain rates of 30–40% during the first 24−48 hours. Here lies the importance of seeking measures to improve this situation, such as the pudendal nerve block with local anesthetic. However, the variability of the pudendal nerve sometimes makes its blockade ineffective and for this reason nerve location methods are sought to achieve a higher rate of success. The main aim of the study is to compare pain in the immediate postoperative period (24 h) after hemorrhoidectomy in patients with pudendal nerve block guided by anatomical references and guided by neurostimulation.

Methods

The present project proposes the performance of a single-center, triple-blind, randomized clinical trial of efficacy, carried out under conditions of routine clinical practice. Patients over 18 years old with hemorrhoids refractory to medical treatment, symptomatic grade III-IV and grade II hemorrhoids that do not respond to conservative procedures in a third level hospital in Spain and that are subsidiaries of surgery in major ambulatory surgery will be included. Demographic variables, variables on hemorrhoidal pathology, details of surgery, verbal numeric pain scale in the preoperative period and surgical complications will be collected.

Results

Not avaliable until the end of the study.

Conclusions

The pudendal nerve block guided by anatomical landmarks has been shown to be useful in postoperative pain control after hemorrhoidectomy although the use of the neurostimulator has not been well studied and we believe it may improve outcom
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有无神经刺激的阴部神经阻滞术对减轻肿瘤切除术后疼痛的有效性临床试验方案。
简介痔疮是最常见的肛肠疾病,发病率占成年人的 44%。最有效的治疗方法是手术,但术后疼痛率也最高,在最初的 24-48 小时内,中度至重度疼痛率为 30-40%。因此,必须采取措施改善这种情况,例如使用局麻药进行阴部神经阻滞。然而,阴部神经的多变性有时会导致阻滞效果不佳,因此需要寻求神经定位方法来提高成功率。本研究的主要目的是比较在解剖学参考和神经刺激引导下进行阴股神经阻滞的痔切除术患者术后即刻(24 小时)的疼痛情况:本项目拟在常规临床实践条件下进行单中心、三盲、随机临床疗效试验。西班牙一家三级医院将纳入 18 岁以上的痔疮患者,他们都是药物治疗难治性痔疮、无症状的 III-IV 级和 II 级痔疮患者,这些患者对保守治疗无效,而且是主要门诊手术的手术补助对象。将收集人口统计学变量、痔疮病理学变量、手术细节、术前口头数字疼痛量表和手术并发症:结论:阴部神经阻滞引导下的痔疮治疗效果显著:尽管神经刺激器的使用尚未得到充分研究,但在解剖标志引导下进行的阴部神经阻滞已被证明有助于控制痔切除术后的疼痛,我们相信它可能会改善手术效果。
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