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Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111302
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

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

Condition or disease Intervention/treatment Phase
Postoperative Pain After Hemorrhoidectomy Other: IV-PCA Other: IV-dezocine Other: IV-PCA+AA Other: IV-dezocine+AA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Experimental: IV-PCA
use IV-PCA for postoperative pain
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.

Experimental: IV-dezocine
use IV-dezocine for postoperative pain
Other: 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.

Experimental: IV-PCA+AA
use IV-PCA and AA for postoperative pain
Other: 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.

Experimental: IV-dezocine+AA
use IV-dezocine and AA for postoperative pain
Other: 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.




Primary Outcome Measures :
  1. Visual Analogue Scale(VAS) [ Time Frame: 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 :
  1. Hospital Anxiety and Depression scale(HAD) [ Time Frame: 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).


Other Outcome Measures:
  1. The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules) [ Time Frame: Day 7 after natural allocation ]
    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%.

  2. Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules) [ Time Frame: Day 7 after natural allocation ]
    The total analgesic drugs dose of each group was considered as the amount of analgesics in the group

  3. Tissue edema [ Time Frame: Day 3,day 4,day 5,day 6 and day 7 after natural allocation ]
    The degree of tissue edema was observed and recorded truthfully



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111302


Contacts
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Contact: Di Qin, MD 028-87526671 qindi@stu.cdutcm.edu.cn
Contact: Wenyan Peng, MD 028-87526671

Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Hui Zheng, phD Chengdu University of Traditional Chinese Medicine
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Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04111302    
Other Study ID Numbers: CXTD1702
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chengdu University of Traditional Chinese Medicine:
hemorrhoidectiomy
postoperative pain
auricular pressure
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dezocine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents