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

NCT ID: NCT04111081

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-07-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Auricular pressure

Use wangbuliuxing seed to stimulate auricular acupuncture point.

Group Type: EXPERIMENTAL

Auricular pressure

Intervention Type: OTHER

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.

Sham auricular pressure

Use wangbuliuxing seed to stimulate auricular acupuncture point.

Group Type: SHAM_COMPARATOR

Shame auricular pressure

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Chengdu University of Traditional Chinese Medicine

Locations

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

Other Identifiers

CXTD1701

Identifier Type: -

Identifier Source: org_study_id