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Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy

Primary Purpose

Postoperative Pain After Hemorrhoidectomy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IV-PCA
IV-dezocine
IV-PCA+AA
IV-dezocine+AA
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain After Hemorrhoidectomy focused on measuring hemorrhoidectiomy, postoperative pain, auricular pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    IV-PCA

    IV-dezocine

    IV-PCA+AA

    IV-dezocine+AA

    Arm Description

    use IV-PCA for postoperative pain

    use IV-dezocine for postoperative pain

    use IV-PCA and AA for postoperative pain

    use IV-dezocine and AA for postoperative pain

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    September 17, 2019
    Last Updated
    February 13, 2020
    Sponsor
    Chengdu University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04111302
    Brief Title
    Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy
    Official Title
    Cohort Study of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    January 1, 2023 (Anticipated)
    Study Completion Date
    May 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chengdu University of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain After Hemorrhoidectomy
    Keywords
    hemorrhoidectiomy, postoperative pain, auricular pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IV-PCA
    Arm Type
    Experimental
    Arm Description
    use IV-PCA for postoperative pain
    Arm Title
    IV-dezocine
    Arm Type
    Experimental
    Arm Description
    use IV-dezocine for postoperative pain
    Arm Title
    IV-PCA+AA
    Arm Type
    Experimental
    Arm Description
    use IV-PCA and AA for postoperative pain
    Arm Title
    IV-dezocine+AA
    Arm Type
    Experimental
    Arm Description
    use IV-dezocine and AA for postoperative pain
    Intervention Type
    Other
    Intervention Name(s)
    IV-PCA
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    IV-dezocine
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    IV-PCA+AA
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    IV-dezocine+AA
    Intervention Description
    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 Measure Information:
    Title
    Visual Analogue Scale(VAS)
    Description
    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.
    Time Frame
    Day 1 to 7 and month 3 and 6 after natural allocation
    Secondary Outcome Measure Information:
    Title
    Hospital Anxiety and Depression scale(HAD)
    Description
    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).
    Time Frame
    Three hours, day 3, and day 7 after natural allocation
    Other Pre-specified Outcome Measures:
    Title
    The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules)
    Description
    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%.
    Time Frame
    Day 7 after natural allocation
    Title
    Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)
    Description
    The total analgesic drugs dose of each group was considered as the amount of analgesics in the group
    Time Frame
    Day 7 after natural allocation
    Title
    Tissue edema
    Description
    The degree of tissue edema was observed and recorded truthfully
    Time Frame
    Day 3,day 4,day 5,day 6 and day 7 after natural allocation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet the diagnostic criteria of grade II-IV mixed hemorrhoids and meet the operation conditions; Age 18~65; External stripping and internal ligation of mixed hemorrhoids, general anesthesia or lumbar shu point anesthesia; VAS score ≥3 points; 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Di Qin, MD
    Phone
    028-87526671
    Email
    qindi@stu.cdutcm.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wenyan Peng, MD
    Phone
    028-87526671
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hui Zheng, phD
    Organizational Affiliation
    Chengdu University of Traditional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy

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