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

• Published in: Revista española de anestesiología y reanimación (English ed.) 2024-10, Vol.71 (8), p.570-575
• Main Authors: Soto Sánchez, A., Cano Valderrama, O., Vilela Ferrer, I., Díaz Jiménez, N., Hernández Barroso, M., Bravo García, P.L., Hernández Hernández, G., Balanzá, J.J.
• Format: Article
• Language: English
• Subjects: Bloqueo nervio pudendo; Dolor posthemorroidectomía; Hemorrhoidectomy; Hemorroidectomía; Neuroestimulación; Neurostimulation; Posthemorrhoidectomy pain; Pudendal nerve block
• ISSN: 2341-1929; 2341-1929
• DOI: 10.1016/j.redare.2024.05.005

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. 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. Not avaliable until the end of the study. 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 La patología hemorroidal es el problema proctológico más frecuente con una prevalencia de 44% de la población adulta. El tratamiento más eficaz es la cirugía, pero también es la que presenta mayor tasa de dolor postoperatorio con unas tasas de dolor moderado a severo de 30–40 % durante las primeras 24−48 h. Aquí radica la importancia de buscar medidas que mejoren esta situación, como es el bloqueo del nervio pudendo con anestésico local. Sin embargo, la variabilidad del nervio pudendo hace que a veces su bloqueo sea inefectivo y por ello se buscan formas de neurolocalización para conseguir mayor tasa de éxito. El objetivo principal del estudio es comparar el dolor en el postoperatorio inmediato (24 h) tras hemorroidectomía en pacientes con bloqueo del ner