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临床试验/NCT04111302
NCT04111302Unknown不适用

Cohort Study of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy

Chengdu University of Traditional Chinese Medicine0 个研究点目标入组 240 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
主要终点
Visual Analogue Scale(VAS)

研究概览

简要总结

Auricular pressure is effective for postoperative analgesia after hemorrhoidectomy, but the evidence is not sufficient.

详细描述

This is a cohort study to study the analgesic effect of auricular pressure pill on persistent pain after hemorrhoidectiomy. Baseline pain intensity scores (VAS>3) of the subjects will be collected 3 hours after the operation of the patients. By doctors' recommend interventions and the patients' preference, eligible subjects were naturally divided into the following queues: intravenous patient-controlled analgesia(IV-PCA),intravenous dezocine(IV-dezocine),intravenous patient-controlled analgesia+auricular acupressure(IV-PCA+AA),intravenous dezocine+auricular acupressure(IV-dezocine+AA). The treatment will last 5-7 days. Participants will receive auricular pressure once two days, and receive VAS, concomitant medication, PONV intensity scale and peripheral edema were recorded daily, and after the operation 3 hours, 3 days and 7 days the patients will receive anxiety and depression scale(HAD) , and VAS data will be collected by telephone at 3 and 6 months after the operation.

The main indicators will be analyzed by VAS score and generalized linear model, with VAS results as the dependent variable, grouping as the random factor, surgical method, mixed hemorrhoid classification as fixed effects factor, and age, course of disease, baseline VAS scores and VAS follow-up time point as the covariables to analysis VAS score improved relations between various factors. Analgesic usage, ease pain evaluation method and using the same scale and HAD GLM model analysis.The secondary indicator analgesic usage rate will be analyzed using logistic regression analysis. fixed effects and covariate factors set with the GLM model.

The purpose of this study was to seek high quality evidence-based medical evidence for intervention of auricular pressure pills on postoperative pain of hemorrhoidectomy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the diagnostic criteria of grade II-IV mixed hemorrhoids and meet the operation conditions;
  • Age 18~65;
  • External stripping and internal ligation of mixed hemorrhoids, general anesthesia or lumbar shu point anesthesia;
  • VAS score ≥3 points;
  • Sign informed consent.

排除标准

  • Combined cognitive impairment could not complete the efficacy evaluation;
  • With other gastrointestinal conditions found during operation;
  • With severe cardiovascular, hepatic, or renal diseases;
  • With opioid addiction

结局指标

主要结局

Visual Analogue Scale(VAS)

时间窗: Day 1 to 7 and month 3 and 6 after natural allocation

It is a unidimensional measure providing a simple solution for measuring subjective experience. The VAS scale is a 10-cm line with 0 cm indicating no symptoms and 10 cm indicates the greatest extent of symptoms.

次要结局

  • Hospital Anxiety and Depression scale(HAD)(Three hours, day 3, and day 7 after natural allocation)

研究者

发起方
Chengdu University of Traditional Chinese Medicine
申办方类型
Other
责任方
Sponsor

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