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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Other: Shame auricular pressure; Other: Auricular pressure

• Registration Number: NCT04111081
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-29
• Study First Posted: 2019-10-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18
• Study Start: 2020-03-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Meet the diagnostic criteria of grade II-IV mixed hemorrhoids and meet the operation conditions;
2. Age 18~65;
3. External stripping and internal ligation of mixed hemorrhoids, general anesthesia or lumbar shu point anesthesia;
4. VAS score ≥3 points after the implementation of analgesia pump;
5. Improve clinical auxiliary examination and sign informed consent.

Exclusion Criteria

1. Combined with inflammatory hemorrhoids, thrombotic hemorrhoids, perianal eczema, perianal abscess and other perianal diseases that affect the evaluation of curative effect;
2. Combined with intestinal infectious diseases, intestinal polyps, rectal malignant tumors, etc;
3. Combined with severe cardiovascular disease, immune deficiency, mental disorder, or severe liver and kidney dysfunction;
4. Auricle skin lesions or auricle skin allergy to tape is difficult to tolerate treatment;
5. Combined cognitive impairment could not complete the efficacy; evaluation;
6. Pregnancy or planned pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham auricular pressure	Shame auricular pressure	Use wangbuliuxing seed to stimulate auricular acupuncture point.
Auricular pressure	Auricular pressure	Use wangbuliuxing seed to stimulate auricular acupuncture point.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale(VAS)	Day 1 after randomization.	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. Twenty-four hours after the operation, VAS\>3 in the case of an analgesic pump can be included in the randomized control group.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression scale(HAD)	Twenty-four hours, three days, and seven days after surgery	The HAD scale included measures of anxiety and depression, with scores ranging from 0 to 21. 0-7 points means asymptomatic;A score of 8-10 means suspicious;A score of 11 to 21 means definitely symptomatic( anxiety or depression).
The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules)	Day 7 after randomization.	The ratio of patients using analgesic drugs in each group was calculated (Patients who take bisphenolics once are considered users), and the utilization rate = number of users/total number of users ×100%.
Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)	Day 7 after randomization.	The total analgesic drugs dose of each group was was considered as the amount of analgesics in the group.

Trial Locations

Locations (1)

Chengdu University of Traditional Chinese Medicine; 🇨🇳 Chengdu, Sichuan, China