Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05936918
Status:
UNKNOWN
Last Update Posted:
2023-07-10
First Post:
2023-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059265', 'term': 'Visceral Pain'}], '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'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data collector'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was primarily a randomized controlled study in which patients were randomly assigned to each group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS(visual analogue scale) score', 'timeFrame': 'The day before surgery', 'description': 'Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.'}, {'measure': 'VAS(visual analogue scale) score', 'timeFrame': 'After the operation 30minute', 'description': 'Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.'}, {'measure': 'VAS(visual analogue scale) score', 'timeFrame': 'After the operation 6hour', 'description': 'Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.'}, {'measure': 'VAS(visual analogue scale) score', 'timeFrame': 'After the operation 12hour', 'description': 'Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.'}, {'measure': 'VAS(visual analogue scale) score', 'timeFrame': 'After the operation 24hour', 'description': 'Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.'}, {'measure': 'VAS(visual analogue scale) score', 'timeFrame': 'After the operation 48hour', 'description': 'Postoperative pain is assessed after surgery by using visual analogue scoring. A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.'}], 'secondaryOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'The day before surgery; After the operation 24hours, 48hours', 'description': 'After surgery, patients are asked about nausea and vomiting. Postoperative nausea and vomiting is assessed after surgery by using visual analogue scoring. Using a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no nausea and vomiting, and 10 points represent the most severe nausea and vomiting that is unbearable.'}, {'measure': 'Early postoperative recovery of quality', 'timeFrame': 'The day before surgery; After the operation 24hours, 48hours', 'description': 'The quality of early postoperative recovery was assessed using The Quality of Recovery-15 scale after surgery, scores range from 0 (QoR very poor) to 150 (QoR excellent), with higher scores representing better quality of recovery'}, {'measure': 'Exhaust and bowel movements', 'timeFrame': 'After the operation 24hours, 48hours', 'description': "Record the time of the patient's first exhaust bowel movement after surgery"}, {'measure': 'Concentration of serum interleukin-6', 'timeFrame': 'the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery', 'description': 'Perioperative venous blood was drawn to detect serum interleukin-6'}, {'measure': 'Concentration of serum cortisol', 'timeFrame': 'the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery', 'description': 'Perioperative venous blood was drawn to detect serum cortisol'}, {'measure': 'Concentration of serum C-reactive protein', 'timeFrame': 'the day before surgery; When entering the operating room; 10minutes after peeling; 5 minutes after the operation; The first day after surgery', 'description': 'Perioperative venous blood was drawn to detect serum C-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcutaneous electrical acupoint stimulation', 'Postoperative pain', 'Visceral pain', 'Early recovery after surgery'], 'conditions': ['Pain Postoperative', 'Postoperative Recovery']}, 'descriptionModule': {'briefSummary': 'To explore the application of transcutaneous electrical acupoint stimulation combined with transverse abdominis plane block in Laparoscopic cholecystectomy, in order to reduce postoperative pain and promote postoperative recovery.', 'detailedDescription': 'Percutaneous electrical acupoint stimulation has been applied in preoperative prophylaxis, intraoperative anesthesia and postoperative rehabilitation, and can reduce perioperative anxiety, improve the efficacy of preoperative smoking cessation and alcohol abstinence, and shorten the preoperative fasting time. During surgery, it can reduce the amount of anesthetic drugs, anti-inflammatory and anti-stress effects, stabilize circulation, and protect important organs; After surgery, improve the speed and quality of wake-up of patients, promote the recovery of maintenance function, regulate immune function, and reduce postoperative adverse reactions such as postoperative pain, postoperative nausea and vomiting, postoperative urinary retention, etc. As one of the common nerve blocks, transverse abdominis block is used clinically, and its main function is to relieve perioperative pain and reduce the amount of traumatic stress and analgesic drugs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) class I and II\n* Age 18-65 years\n* Laparoscopic cholecystectomy for the first time\n* There is no rupture, infection in the acupoint pasting site\n* The patient knows and signs the informed consent form\n\nExclusion Criteria:\n\n* People with visual impairment, hearing impairment and alcoholism\n* History of diabetes, myocardial infarction or cerebrovascular accident, liver and kidney dysfunction\n* Those who are allergic to non-steroidal drugs, anticholinergic drugs, and anesthetic drugs\n* Those who are unable to cooperate or refuse to participate in the research or request to withdraw during the research process\n* Those with contraindications to percutaneous electrical stimulation, including local skin damage, infection or implantation of electrophysiological devices in the body'}, 'identificationModule': {'nctId': 'NCT05936918', 'briefTitle': 'Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yangzhou University'}, 'officialTitle': 'Effects of Transcutaneous Electrical Acupoint Stimulation Combined With Transverse Abdominis Plane Block on Perioperative Pain and Early Postoperative Recovery in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '2023-YKL04- (ke04)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TT group', 'description': 'Bilateral Neiguan acupuncture points (PC6), Hegu acupuncture points (LI4), Zusanli (ST36) were selected, and percutaneous acupuncture points were electrically stimulated with electronic acupuncture equipment 30min before anesthesia, and then bilateral abdominal transverse plane blockade was performed', 'interventionNames': ['Other: Transcutaneous electrical acupoint stimulatios', 'Other: Bilateral transverse abdominal plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TE group', 'description': 'Bilateral Neiguan acupuncture points (PC6), Hegu acupuncture points (LI4), Zusanli (ST36) were selected, and percutaneous acupuncture points were electrically stimulated with electronic acupuncture equipment 30min before anesthesia', 'interventionNames': ['Other: Transcutaneous electrical acupoint stimulatios']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TA group', 'description': 'Bilateral transverse abdominal plane block is performed prior to anesthesia', 'interventionNames': ['Other: Bilateral transverse abdominal plane block']}, {'type': 'NO_INTERVENTION', 'label': 'C group', 'description': 'Percutaneous electrical stimulation of acupoints and transverse abdominis plane block are not permitted before anesthesia'}], 'interventions': [{'name': 'Transcutaneous electrical acupoint stimulatios', 'type': 'OTHER', 'description': 'Percutaneous electrical stimulation technology of acupuncture points is a technology that uses a trace current close to human bioelectricity on the surface of acupuncture points to prevent and treat diseases guided by meridian theory, and is a new treatment of percutaneous nerve electrical stimulation combined with acupuncture points. As one of the related techniques of acupuncture, it is a safe, non-invasive, simple and new acupoint stimulation method', 'armGroupLabels': ['TE group', 'TT group']}, {'name': 'Bilateral transverse abdominal plane block', 'type': 'OTHER', 'description': 'Transverse abdominis plane block is a technique in which a local anesthetic is injected into the transverse abdominis plane to block sensory nerves passing through this plane to achieve analgesic effect', 'armGroupLabels': ['TA group', 'TT group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yangzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wang wanxia', 'investigatorAffiliation': 'Yangzhou University'}}}}