Clinical trial NCT04111302: Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy
Official title: Cohort Study of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain After Hemorrhoidectomy
Keywords: hemorrhoidectiomy
postoperative pain
auricular pressure
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_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 cohort 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 3 hours after the operation of the patients. By doctors' recommend interventions and the patients' preference, eligible subjects were naturally divided into the following queues: intravenous patient-controlled analgesia(IV-PCA),intravenous dezocine(IV-dezocine),intravenous patient-controlled analgesia+auricular acupressure(IV-PCA+AA),intravenous dezocine+auricular acupressure(IV-dezocine+AA). 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 3 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 main indicators will be analyzed by VAS score and generalized linear model, with VAS results as the dependent variable, grouping as the random factor, surgical method, mixed hemorrhoid classification as fixed effects factor, and age, course of disease, baseline VAS scores and VAS follow-up time point as the covariables to analysis VAS score improved relations between various factors. Analgesic usage, ease pain evaluation method and using the same scale and HAD GLM model analysis.The secondary indicator analgesic usage rate will be analyzed using logistic regression analysis. fixed effects and covariate factors set with the GLM model.

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;
5. Sign informed consent.

Exclusion Criteria:

* Combined cognitive impairment could not complete the efficacy evaluation;
* With other gastrointestinal conditions found during operation;
* With severe cardiovascular, hepatic, or renal diseases;
* With opioid addiction

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: Day 1 to 7 and month 3 and 6 after natural allocation
Secondary outcomes:
measure: Hospital Anxiety and Depression scale(HAD)
timeFrame: Three hours, day 3, and day 7 after natural allocation
Other outcomes:
measure: The utilization rate of analgesic drugs（Diclofenac Sodium Dual Release Enteric-coated Capsules)
timeFrame: Day 7 after natural allocation
measure: Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)
timeFrame: Day 7 after natural allocation
measure: Tissue edema
timeFrame: Day 3,day 4,day 5,day 6 and day 7 after natural allocation
Locations:
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Hui Zheng, phD
role: PRINCIPAL_INVESTIGATOR
References: