Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06172920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 groups of patients are received different type of analgesics'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The rate of drugs's analgesic effects", 'timeFrame': 'postoperative 24 hours', 'description': 'To compare the analgesic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be assesed with numeric rating scale ( 0= no pain, 10= worst pain imaginable)'}, {'measure': 'Comparing hemodynamic effects', 'timeFrame': 'Intraoperatively, then postoperative 24 hours', 'description': 'To compare hemodynamic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be asssesed with measurements of intraoperative values of systolic, diastolic and mean arterial blood pressure'}, {'measure': 'Comparing respiratory effects', 'timeFrame': 'postoperative 24 hours', 'description': 'To compare respiratory effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery. It will be asssesed with postoperative pulmonary complications such as failed extubation, bronchospasms or respiratory depressions.'}], 'secondaryOutcomes': [{'measure': 'Adverse effects of analgesics', 'timeFrame': 'postoperative 24 hours', 'description': 'It was aimed to compare the effects of drugs in terms of side effects, early mobilization.'}, {'measure': 'surgeon satisfaction', 'timeFrame': 'Immediately after the surgery', 'description': 'With a questionnaire, surgeon satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree)'}, {'measure': 'patient satisfaction', 'timeFrame': 'Postoperative 30th minute', 'description': 'With a questionnaire, patient satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree) When Aldrete score\\> 8, patient will be questioned for satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thoracic surgery', 'patient controlled analgesia', 'postoperative care unit', 'intensive care'], 'conditions': ['Thoracic Diseases', 'Analgesia']}, 'descriptionModule': {'briefSummary': 'Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery', 'detailedDescription': 'Thoracotomy is one of the most painful surgical procedures known, and severe pain is encountered in 21-67% of patients after thoracotomy. The most important causes of this pain arise from the bone structures of the thoracic wall, damage to the costal joint junctions, stretching of the ligaments, rib fractures, and damage to the intercostal nerve and major muscles. Another factor that causes pain after thoracotomy is the chest tubes placed in the thorax to provide drainage (1).\n\nAs a result of this pain caused by loss of tissue and pulmonary reserve, effective coughing and decreased chest expansion can lead to serious complications such as atelectasis, ventilation/perfusion mismatch, hypoxemia, immobilization, thromboembolism and infection. These complications are associated with increased morbidity and mortality in thoracic surgery (2).\n\nEnsuring pain management in patients undergoing thoracotomy is important in terms of reducing postoperative complications, ensuring early mobilization and increasing patient comfort. Since there is no single source that causes pain after thoracotomy, pain must be controlled at all levels. For this reason, a multimodal approach using pharmacological and non-pharmacological techniques is preferred in analgesia after thoracotomy. This approach reduces drug side effects along with the consumption of analgesics. Opioids and nonsteroidal anti-inflammatory drugs are used in pharmacological analgesia.\n\nIn our study, the investigators aim to compare the effects of tramadol, pethidine and morphine using intravenous patient-controlled analgesia in the treatment of postoperative pain in elective thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having non-urgent thoracic surgery\n* over 18 years old\n* Being in group I-III according to the American Society of Anesthesiologists (ASA) classification\n* Not have allergies to the drugs to be used (volunteers with diseases that prevent the use of drugs will not be included in the study\n* regardless of gender\n\nExclusion Criteria:\n\n. Have allergies to the drugs to be used'}, 'identificationModule': {'nctId': 'NCT06172920', 'briefTitle': 'Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'Comparison of the Analgesic Effects of Tramadol, Pethidine and Morphine Under Erector Spinae Plane (ESP) Block in the Treatment of Pain After Elective Thoracic Surgery', 'orgStudyIdInfo': {'id': 'KA23/137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol', 'description': 'Tramadol receiving group', 'interventionNames': ['Drug: Tramadol hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aldolan', 'description': 'Aldolan receiving group', 'interventionNames': ['Drug: Aldolan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'description': 'Morphine receiving group', 'interventionNames': ['Drug: Morphine hydrochloride']}], 'interventions': [{'name': 'Tramadol hydrochloride', 'type': 'DRUG', 'description': 'Patients are receiving tramadol hydrochloride under thoracic surgery', 'armGroupLabels': ['Tramadol']}, {'name': 'Aldolan', 'type': 'DRUG', 'description': 'Patients are receiving meperidine under thoracic surgery', 'armGroupLabels': ['Aldolan']}, {'name': 'Morphine hydrochloride', 'type': 'DRUG', 'description': 'Patients are receiving Morphine hydrochloride under thoracic surgery', 'armGroupLabels': ['Morphine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Adnan Torgay, Professor;MD', 'role': 'CONTACT', 'email': 'atorgay@gmail.com', 'phone': '+905307384682'}], 'facility': 'Baskent University Ankara Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Begum N Gokdemir, MD', 'role': 'CONTACT', 'email': 'begokdemir@yahoo.com', 'phone': '03122036868'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Begüm Nemika Gökdemir, Research Assistant of Anesthesiology Department', 'investigatorFullName': 'Begüm Nemika Gökdemir', 'investigatorAffiliation': 'Baskent University'}}}}