NCT04111081

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

Pilot Study of Clinical Randomized Controlled Trial of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
OTHER	Auricular pressure	Select related auricular points: Shenmen(TF4), sympathetic(AH6a), rectum(HX2), anus(HX5), stomach(CO4), subcortical(AT4). The auricle skin of the patient was disinfected 24 hours after the operation, and wanghuoxing seed will be used for stimulation. Ask patients press every two hours for one minute at each point. When the pain is severe, do pressure compressions at each point for 2 minutes once hour.
OTHER	Shame auricular pressure	Select unrelated auricular points: eye(LO5), occipital(AT3), tonsil(LO7,8,9), lower auricular root(R3), dorsum auricular kidney(P5) and dorsum auricular lung(P2). The auricle skin of the patient was disinfected 24 hours after the operation, and wanghuoxing seed will be used for stimulation. Ask patients press every two hours for one minute at each point. When the pain is severe, do pressure compressions at each point for 2 minutes once hour.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-10-01
• Last updated: 2020-02-18

Locations

1 site across 1 country: China