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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-29', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The utilization rate of analgesic drugs（Diclofenac Sodium Dual Release Enteric-coated Capsules)', 'timeFrame': 'Day 7 after natural allocation', '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%.'}, {'measure': 'Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)', 'timeFrame': 'Day 7 after natural allocation', 'description': 'The total analgesic drugs dose of each group was considered as the amount of analgesics in the group'}, {'measure': 'Tissue edema', 'timeFrame': 'Day 3,day 4,day 5,day 6 and day 7 after natural allocation', 'description': 'The degree of tissue edema was observed and recorded truthfully'}], 'primaryOutcomes': [{'measure': 'Visual Analogue Scale(VAS)', 'timeFrame': 'Day 1 to 7 and month 3 and 6 after natural allocation', '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.'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression scale(HAD)', 'timeFrame': 'Three hours, day 3, and day 7 after natural allocation', '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemorrhoidectiomy', 'postoperative pain', 'auricular pressure'], 'conditions': ['Postoperative Pain After Hemorrhoidectomy']}, 'descriptionModule': {'briefSummary': 'Auricular pressure is effective for postoperative analgesia after hemorrhoidectomy, but the evidence is not sufficient.', 'detailedDescription': "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.\n\nThe 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.\n\nThe purpose of this study was to seek high quality evidence-based medical evidence for intervention of auricular pressure pills on postoperative pain of hemorrhoidectomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet the diagnostic criteria of grade II-IV mixed hemorrhoids and meet the operation conditions;\n2. Age 18\\~65;\n3. External stripping and internal ligation of mixed hemorrhoids, general anesthesia or lumbar shu point anesthesia;\n4. VAS score ≥3 points;\n5. Sign informed consent.\n\nExclusion Criteria:\n\n* Combined cognitive impairment could not complete the efficacy evaluation;\n* With other gastrointestinal conditions found during operation;\n* With severe cardiovascular, hepatic, or renal diseases;\n* With opioid addiction'}, 'identificationModule': {'nctId': 'NCT04111302', 'briefTitle': 'Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'Cohort Study of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy', 'orgStudyIdInfo': {'id': 'CXTD1702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV-PCA', 'description': 'use IV-PCA for postoperative pain', 'interventionNames': ['Other: IV-PCA']}, {'type': 'EXPERIMENTAL', 'label': 'IV-dezocine', 'description': 'use IV-dezocine for postoperative pain', 'interventionNames': ['Other: IV-dezocine']}, {'type': 'EXPERIMENTAL', 'label': 'IV-PCA+AA', 'description': 'use IV-PCA and AA for postoperative pain', 'interventionNames': ['Other: IV-PCA+AA']}, {'type': 'EXPERIMENTAL', 'label': 'IV-dezocine+AA', 'description': 'use IV-dezocine and AA for postoperative pain', 'interventionNames': ['Other: IV-dezocine+AA']}], 'interventions': [{'name': 'IV-PCA', 'type': 'OTHER', '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.', 'armGroupLabels': ['IV-PCA']}, {'name': 'IV-dezocine', 'type': 'OTHER', '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.', 'armGroupLabels': ['IV-dezocine']}, {'name': 'IV-PCA+AA', 'type': 'OTHER', '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.', 'armGroupLabels': ['IV-PCA+AA']}, {'name': 'IV-dezocine+AA', 'type': 'OTHER', '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.', 'armGroupLabels': ['IV-dezocine+AA']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Di Qin, MD', 'role': 'CONTACT', 'email': 'qindi@stu.cdutcm.edu.cn', 'phone': '028-87526671'}, {'name': 'Wenyan Peng, MD', 'role': 'CONTACT', 'phone': '028-87526671'}], 'overallOfficials': [{'name': 'Hui Zheng, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}