Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy

Not Applicable

• Conditions: Postoperative Pain After Hemorrhoidectomy
• Interventions: Other: IV-dezocine; Other: IV-PCA+AA; Other: IV-PCA; Other: IV-dezocine+AA

• Registration Number: NCT04111302
• 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 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.

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: 2020-02-13
• Last Update Posted: 2020-02-17
• Study Start: 2020-05-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV-dezocine	IV-dezocine	use IV-dezocine for postoperative pain
IV-PCA+AA	IV-PCA+AA	use IV-PCA and AA for postoperative pain
IV-PCA	IV-PCA	use IV-PCA for postoperative pain
IV-dezocine+AA	IV-dezocine+AA	use IV-dezocine and AA for postoperative pain

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale(VAS)	Day 1 to 7 and month 3 and 6 after natural allocation	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.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression scale(HAD)	Three hours, day 3, and day 7 after natural allocation	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).