Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 6:44 PM
Study NCT ID:
NCT06517069
Status:
RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of TEAS Combined With Oxycodone on Postoperative Visceral Pain in Gynecologic Laparoscopic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059265', 'term': 'Visceral Pain'}], 'ancestors': [{'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-27', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the VAS score of postoperative visceral pain', 'timeFrame': '30 minutes after surgery、6 hours after surgery、24 hours after surgery、48 hours after surgery', 'description': 'the visual analogue scale of postoperative visceral pain,The basic method is to use a swimming scale about 10cm long, marked with 10 scales on one side, and "0" and "10" at each end, with 0 being painless and 10 being the most unbearable pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Visceral Pain']}, 'descriptionModule': {'briefSummary': 'To investigate the effect and feasibility of percutaneous acupoint stimulation combined with oxycodone on postoperative visceral pain in laparoscopic patients, and provided a clinical basis for optimizing perioperative pain management in laparoscopic patients.', 'detailedDescription': 'Patients aged 18-65 years old, BMI 18-30kg/m2, ASA grade I or II were selected for gynecologic laparoscopic surgery (laparoscopic ovarian tumor stripping, laparoscopic uterine fibroid stripping, laparoscopic total hysterectomy) under general anesthesia from May 2024 to July 2024. Exclusion criteria: Patients who were allergic to the drugs used in the study, had confusion or cognitive impairment, contraindicated percutaneous acupoint electrical stimulation, abnormal cardiopulmonary and liver and kidney function, history of analgesic drug use within one week, history of diabetes, myocardial infarction, or cerebrovascular accident. Exclusion criteria: patients dropped out of the experiment midway or the data was not completely collected, the surgical method changed midway, the operation duration was less than 30 minutes or more than 2 hours, and patients with opioid and addictive drug dependence'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* American Society of Anesthesiologists grade I-II\n* Body mass index (BMI) 18.5-30 kg/m2;\n* No ulceration or infection at the acupuncture stimulation site.\n\nExclusion Criteria:\n\n* Allergic to the drugs used in the study;\n* People with unclear consciousness or cognitive dysfunction;\n* There are contraindications of percutaneous acupoint electrical stimulation;\n* Abnormal cardiopulmonary and liver and kidney function;\n* History of analgesic drug use within one week;\n* History of diabetes, myocardial infarction or cerebrovascular accident.'}, 'identificationModule': {'nctId': 'NCT06517069', 'briefTitle': 'Effect of TEAS Combined With Oxycodone on Postoperative Visceral Pain in Gynecologic Laparoscopic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yangzhou University'}, 'officialTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation Combined With Oxycodone on Postoperative Visceral Pain and Early Recovery Quality in Gynecologic Laparoscopic Patients', 'orgStudyIdInfo': {'id': 'Kang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEAS combined with Oxycodone', 'description': 'Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction; Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction', 'interventionNames': ['Other: TEAS', 'Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'TEAS', 'description': 'Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction; The same amount of normal saline was injected intravenously 5 minutes before anesthesia induction.', 'interventionNames': ['Other: TEAS']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone', 'description': 'Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Stick electrodes only but do not stimulate; Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'NO_INTERVENTION', 'label': 'Comparator', 'description': 'Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Stick electrodes only but do not stimulate; The same amount of normal saline was injected intravenously 5 minutes before anesthesia induction.'}], 'interventions': [{'name': 'TEAS', 'type': 'OTHER', 'description': 'Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction', 'armGroupLabels': ['TEAS', 'TEAS combined with Oxycodone']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction', 'armGroupLabels': ['Oxycodone', 'TEAS combined with Oxycodone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225000', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Meiyu, Director', 'role': 'CONTACT', 'email': 'meiyuliu@yzu.edu.cn', 'phone': '17761980727'}], 'facility': 'Affiliated Hospital of Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Meiyu Liu', 'role': 'CONTACT', 'email': 'myliu@yzu.edu', 'phone': '+86 177 6198 0727'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yangzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wang wanxia', 'investigatorAffiliation': 'Yangzhou University'}}}}