Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy

Chengdu University of Traditional Chinese Medicine

Status: Unknown

Conditions: Postoperative Pain After Hemorrhoidectomy

Treatments: Other: IV-PCA+AA; Other: IV-PCA; Other: IV-dezocine; Other: IV-dezocine+AA

Study type: Interventional

Funder types: Other

Identifiers

NCT04111302

CXTD1702

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

IV-PCA

Experimental group

Description:

use IV-PCA for postoperative pain

Treatment:

Other: IV-PCA

IV-dezocine

Experimental group

Description:

use IV-dezocine for postoperative pain

Treatment:

Other: IV-dezocine

IV-PCA+AA

Experimental group

Description:

use IV-PCA and AA for postoperative pain

Treatment:

Other: IV-PCA+AA

IV-dezocine+AA

Experimental group

Description:

use IV-dezocine and AA for postoperative pain

Treatment:

Other: IV-dezocine+AA