Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-11 @ 10:05 AM
Study NCT ID:
NCT04111302
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy
Sponsor:
Chengdu University of Traditional Chinese Medicine
Organization:
Study Overview
Official Title:
Cohort Study of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: