Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy

Postoperative Pain After Hemorrhoidectomy Clinical Trial

Official title:

Cohort Study of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04111302
• Other study ID #: CXTD1702
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Di Qin, MD
• Phone: 028-87526671
• Email: qindi[@]stu.cdutcm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: May 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain After Hemorrhoidectomy

Intervention

Other:
• IV-PCA
IV-PCA contains dezocine 10mg, sufentanil 100ug, metoclopramide 20mg and normal saline are prepared into 100ml solution and pumped evenly at the speed of 2ml/h.
• IV-dezocine
IV-dezocine contains dezocine 5mg and 250ml normal saline are made into solution and injected intravenously twice a day for 3 consecutive days after surgery.
• IV-PCA+AA
IV-PCA contains dezocine 10mg, sufentanil 100ug, metoclopramide 20mg and normal saline are prepared into 100ml solution and pumped evenly at the speed of 2ml/h. And selecting the auricular points TF4, AH6a, HX2, HX5, CO4, AT4 and cowherb seeds will be attached to each auricular point after the auricle skin is disinfected. The participants will be asked to press the cowherb seeds against the auricular points every 2 hours during waking hours; each point is stimulated for one minute. Auricular points are pressed unilaterally, and the cowherb seeds will be replaced with new ones every 2 days, alternating from left to right.
• IV-dezocine+AA
IV-dezocine contains dezocine 5mg and 250ml normal saline are made into solution and injected intravenously twice a day for 3 consecutive days after surgery.And selecting the auricular points TF4, AH6a, HX2, HX5, CO4, AT4 and cowherb seeds will be attached to each auricular point after the auricle skin is disinfected. The participants will be asked to press the cowherb seeds against the auricular points every 2 hours during waking hours; each point is stimulated for one minute. Auricular points are pressed unilaterally, and the cowherb seeds will be replaced with new ones every 2 days, alternating from left to right.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules)	The ratio of patients using analgesic drugs in each group was calculated (Patients who take bisphenolics once are considered users), and the utilization rate = number of users/total number of users ×100%.	Day 7 after natural allocation
Other	Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)	The total analgesic drugs dose of each group was considered as the amount of analgesics in the group	Day 7 after natural allocation
Other	Tissue edema	The degree of tissue edema was observed and recorded truthfully	Day 3,day 4,day 5,day 6 and day 7 after natural allocation
Primary	Visual Analogue Scale(VAS)	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.	Day 1 to 7 and month 3 and 6 after natural allocation
Secondary	Hospital Anxiety and Depression scale(HAD)	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).	Three hours, day 3, and day 7 after natural allocation