Clinical trial NCT04111081: Auricular Pressure for Postoperative Pain After Hemorrhoidectiomy: a Randomized Controlled Trial
Official title: Pilot Study of Clinical Randomized Controlled Trial of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: hemorrhoidectiomy
postoperative pain
auricular pressure
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: Day 1 after randomization.
Secondary outcomes:
measure: Hospital Anxiety and Depression scale(HAD)
timeFrame: Twenty-four hours, three days, and seven days after surgery
measure: The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules)
timeFrame: Day 7 after randomization.
measure: Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)
timeFrame: Day 7 after randomization.
Other outcomes:
measure: Tissue edema
timeFrame: Day 3, day4, day5, day6 and day7 after randomization.
Locations:
city: Chengdu
country: China
facility: Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Hui Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: