预防性镇痛在痔切除术的应用：前瞻性、随机、双盲临床试验研究方案。

Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial.

机构信息

Surgical Department, Moscow Research Educational Center of the Lomonosov Moscow State University, Moscow, 101000, Russia.

Department: Clinic of Colorectal and Minimally Invasive Surgery, Sechenov First Moscow State Medical University, Moscow, 101000, Russia.

出版信息

Trials. 2022 Jun 27;23(1):536. doi: 10.1186/s13063-022-06107-0.

DOI:10.1186/s13063-022-06107-0

PMID:35761383

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9235219/

Abstract

BACKGROUND

Hemorrhoidectomy is associated with intense postoperative pain that requires multimodal analgesia. It includes nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics to reach adequate pain control. There are data in literature preemptive analgesia could decrease postoperative pain after hemorrhoidectomy. The aim of this study is to assess the efficacy of preemptive analgesia with ketoprofen 100 mg 2 h before procedure per os with spinal anesthesia to decrease postoperative pain according to visual analog scale and to reduce the opioids and other analgesics consumption.

METHODS

Patients of our clinic who meet the following inclusion criteria are included: hemorrhoids grade III-IV and the planned Milligan-Morgan hemorrhoidectomy. After signing the consent all participants are randomly divided into 2 groups: the first one gets a tablet with 100 mg ketoprofen, the second one gets a tablet containing starch per os 2 h before surgery (72 participants per arm). Patients of both arms receive spinal anesthesia and undergo open hemorrhoidectomy. Following the procedure the primary and secondary outcomes are evaluated: opioid administration intake, the pain at rest and during defecation, duration, and frequency of other analgesics intake, readmission rate, overall quality of life, time from the procedure to returning to work, and the complications rate.

DISCUSSION

Multimodality pain management has been shown to improve pain control and decrease opioid intake in patients after hemorrhoidectomy in several studies. Gabapentin can be considered as an alternative approach to pain control as NSAIDs have limitative adverse effects. Systemic admission of ketorolac with local anesthetics also showed significant efficacy in patients undergoing anorectal surgery. We hope to prove the efficacy of multimodal analgesia including preemptive one for patients undergoing excisional hemorrhoidectomy that will help to hold postoperative pain levels no more than 3-4 points on VAS with minimal consumption of opioid analgesics.

TRIAL REGISTRATION

ClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.

摘要

背景

痔切除术与强烈的术后疼痛相关，需要多模式镇痛。它包括非甾体抗炎药（NSAIDs）、对乙酰氨基酚和局部麻醉剂，以达到足够的疼痛控制。文献中有数据表明，预防性镇痛可以降低痔切除术后的疼痛。本研究的目的是评估在椎管内麻醉前行口服酮洛芬 100mg（术前 2 小时）的预防性镇痛效果，以减轻术后疼痛（根据视觉模拟评分），减少阿片类药物和其他镇痛药物的消耗。

方法

符合以下纳入标准的本诊所患者：III-IV 级痔和计划行 Milligan-Morgan 痔切除术。签署同意书后，所有参与者被随机分为两组：第一组口服 100mg 酮洛芬片，第二组口服淀粉片（每组 72 例）。两组患者均接受椎管内麻醉和开放性痔切除术。手术后评估主要和次要结局：阿片类药物的使用量、静息和排便时的疼痛、其他镇痛药物的使用持续时间和频率、再入院率、整体生活质量、从手术到恢复工作的时间以及并发症发生率。

讨论

多项研究表明，多模式疼痛管理可改善痔切除术患者的疼痛控制并减少阿片类药物的使用。加巴喷丁可作为控制疼痛的替代方法，因为 NSAIDs 有局限性的不良反应。局部麻醉剂中联合应用酮咯酸也显示出在接受肛肠手术的患者中具有显著的疗效。我们希望证明包括预防性镇痛在内的多模式镇痛对接受切除术的痔患者的疗效，将有助于将术后疼痛水平控制在 VAS 评分不超过 3-4 分，阿片类镇痛药物的消耗量最小。