Auricular Pressure for Postoperative Pain After Hemorrhoidectiomy: a

Status Enrolling by invitation

Clinical Trial Summary

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

Clinical Trial Description

This is a randomized, double-blind 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 24 hours after the operation of the patients. Eligible subjects will be randomly assigned to receive auricular pressure pills or sham-auricular pressure pills. 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 24 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 statistical analysis results will be subject to the full analysis set (FAS) results, and a sensitivity analysis will be performed comparing the per-protocol (PP). The main indicators will be analyzed by covariance analysis, with VAS results as the dependent variable, grouping as the random factor, and age, course of disease, surgical method and baseline as the covariables to correct the P value. The secondary indicator analgesic usage rate will be analyzed using logistic regression analysis. Whether analgesic will be used as a dependent variable, grouping as a random factor, and age, course of disease, surgical method and evaluation time point will be analyzed as covariables. Other outcome indicators will be analyzed by covariance analysis, and the model will be the same as that of the main indicators. P<0.05 considered as significant difference, and SPSS20.0 used for analysis.

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04111081
Study type	Interventional
Source	Chengdu University of Traditional Chinese Medicine
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	March 1, 2020
Completion date	July 1, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Auricular Pressure for Postoperative Pain After Hemorrhoidectiomy: a Randomized Controlled Trial

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms