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
About this trial
This is an interventional treatment trial for Postoperative Pain After Hemorrhoidectomy focused on measuring hemorrhoidectiomy, postoperative pain, auricular pressure
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
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
NCT ID
NCT04111302
First Posted
September 17, 2019
Last Updated
February 13, 2020
Sponsor
Chengdu University of Traditional Chinese Medicine
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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