Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT06743802
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery
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': 'C024989', 'term': 'coenzyme Q10'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-12-07', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of chronic postsurgical pain', 'timeFrame': 'from the end of surgery to 3 months after surgery'}], 'secondaryOutcomes': [{'measure': 'The incidence of acute postoperative pain with a score ≥4', 'timeFrame': 'from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.', 'description': 'Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score. (NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)'}, {'measure': 'The severity of acute postoperative pain', 'timeFrame': 'from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.', 'description': 'Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)'}, {'measure': 'The severity of chronic postsurgical pain', 'timeFrame': 'from the end of surgery to 3 months after surgery', 'description': 'Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)'}, {'measure': 'The incidence of neuropathic pain', 'timeFrame': 'from the end of surgery to 3 months after surgery', 'description': 'The DN4 questionnaire (Douleur Neuropathique 4) was used to evaluate neuropathic pain. The DN4 is a validated diagnostic tool consisting of 10 items, with scores ranging from 0 to 10. A score of 4 or higher indicates the presence of neuropathic pain.'}, {'measure': 'The frequency of postoperative rescue analgesic use', 'timeFrame': 'from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.'}, {'measure': 'The dose of analgesic use', 'timeFrame': 'from the end of surgery to 6 hours,12 hours, 24 hours and 48 hours after surgery.'}, {'measure': 'The quality of recovery score at 3 days Postoperatively', 'timeFrame': 'from the end of surgery to 3 days.', 'description': 'The QoR-15 scale, ranging from 0 to 150 with higher scores indicating better recovery, was used to assess the quality of recovery on postoperative day 3.'}, {'measure': 'Health related quality of life score at 3 months Postoperatively', 'timeFrame': 'from the end of surgery to 3 months after surgery.', 'description': 'The SF-8 scale, with a scoring range of 0 to 100 where higher scores indicate better physical and mental health, was used to evaluate health-related quality of life at 3 months postoperatively.'}, {'measure': 'Postoperative length of hospital stay', 'timeFrame': 'from end of surgery to about 3 to 7 days after surgery.'}, {'measure': 'The incidence of adverse reactions', 'timeFrame': 'From admission to 3 month post-discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '41025845', 'type': 'DERIVED', 'citation': 'Liu J, Li L, Luo L, Wu N, Xu F, Tao C, Chen J, Huang H, Duan G. Effect of coenzyme Q10 on pain prevention after thoracoscopic surgery: study protocol. Pain Manag. 2025 Sep 30:1-8. doi: 10.1080/17581869.2025.2567832. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the effectiveness of Coenzyme Q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75 years;\n* American Society of Anesthesiology (ASA) physical status classification I-III;\n* Scheduled for elective lung resection surgery under thoracoscopy;\n* Voluntarily opting for patient-controlled intravenous analgesia;\n* Willing to participate in this trial after consultation with the patient or their family and signing the informed consent form.\n\nExclusion Criteria:\n\n* History of previous thoracotomy or thoracoscopic surgery;\n* Patients converted to open thoracotomy intraoperatively;\n* Severe hepatic or renal dysfunction;\n* History of substance abuse;\n* Pregnancy or breastfeeding;\n* History of chronic pain;\n* Use of coenzyme Q10 for more than one month;\n* Allergy to coenzyme Q10;\n* Patients unable to communicate or cooperate.'}, 'identificationModule': {'nctId': 'NCT06743802', 'briefTitle': 'The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Coenzyme Q10 and pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coenzyme Q10', 'interventionNames': ['Drug: Coenzyme Q10']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Coenzyme Q10', 'type': 'DRUG', 'description': 'Coenzyme Q10 was administered from admission to one month after discharge at a dose of 200 mg per day (200 mg/qd).', 'armGroupLabels': ['Coenzyme Q10']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo was administered from hospital admission until one month after discharge.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangyou Duan', 'role': 'CONTACT', 'email': 'duangy@hospital.cqmu.edu.cn', 'phone': '(+86)18323376014'}], 'facility': 'Guangyou Duan', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Guangyou Duan, ph.D', 'role': 'CONTACT', 'email': 'duangy@hospital.cqmu.edu.cn', 'phone': '(+86)18323376014'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}