Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-29 @ 8:24 PM
Study NCT ID:
NCT06330168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paravertebral Calcitonin in Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'triple'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': 'from the end of surgery until the end of the first postoperative day', 'description': 'Total morphine dose consumed in the first 24 hour after surgery'}, {'measure': 'Incidence of chronic pain at 3 months after surgery', 'timeFrame': '3 months after surgery', 'description': 'chronic pain at 3 months after surgery'}], 'secondaryOutcomes': [{'measure': 'numerical rating scale scores', 'timeFrame': 'from arrival to the post-anesthesia care unit until 48 hour after surgery.', 'description': 'A 0-10 numerical rating scale ( 0 means no pain and 10 means the worst pain) at coughing and at rest will be assessed by an investigator during the first and second day post operation'}, {'measure': 'incidence of chronic pain', 'timeFrame': '9 months after surgery', 'description': 'chronic pain at 6 and 9 months after surgery'}, {'measure': 'Side effects', 'timeFrame': 'first postoperative day', 'description': 'hypotension, postoperative nausea and vomiting'}, {'measure': 'Intensity of chronic pain', 'timeFrame': '9 months after surgery', 'description': 'Chronic pain intensity will be assessed at 3, 6 and 9 months after surgery using A 0-10 numerical rating scale (0 means no pain and 10 means the worst pain)'}, {'measure': 'morphine consumption', 'timeFrame': '48 hours after surgery', 'description': 'Total morphine dose consumed during the second postoperative day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Calcitonin', 'Paravertebral', 'Thoracotomy']}, 'descriptionModule': {'briefSummary': 'This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy.', 'detailedDescription': 'Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery. However, few articles demonstrated its effects on acute pain and chronic pain after thoracotomy and revealed high postoperative opioid consumption and inability to reduce the incidence of chronic pain.\n\nCalcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions.\n\nUsing calcitonin as an additive in thoracic paravertebral block was not evaluated in previous studies, investigators conducted this study based on the hypothesis that calcitonin use as an additive in thoracic paravertebral block for patients undergoing thoracotomy may have extended analgesic effects regarding decreasing postoperative pain scores, opioid consumption, and this value may decrease the incidence of chronic post-thoracotomy pain.\n\nIn both groups, ultrasound-guided thoracic paravertebral block will be performed before anesthetic induction using a high-frequency linear probe after identifying the paravertebral space of the proposed level of intercostal skin incision.General anesthesia in both groups will be similar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥ 18 years\n* American society of anesthesiology (ASA) physical status of I-III\n* scheduled for elective thoracotomy\n\nExclusion Criteria:\n\n* Contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy.\n* Pregnancy\n* History of cardiovascular and gastro-esophageal surgery\n* Preexisting pain syndrome or psychological disorders\n* Severe hepatic, cardiovascular, or renal disorders\n* Allergy to calcitonin\n* Patients who will be re-operated and who will report infections'}, 'identificationModule': {'nctId': 'NCT06330168', 'briefTitle': 'Paravertebral Calcitonin in Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Analgesic Value of Paravertebral Calcitonin in Patients Undergoing Thoracotomy', 'orgStudyIdInfo': {'id': '36264PR573/2/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bupivacaine-calcitonin-fentanyl group', 'description': 'thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml)', 'interventionNames': ['Drug: bupivacaine-calcitonin-fentanyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'bupivacaine-fentanyl group', 'description': 'thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.', 'interventionNames': ['Drug: Bupivacaine-fentanyl']}], 'interventions': [{'name': 'bupivacaine-calcitonin-fentanyl', 'type': 'DRUG', 'description': 'pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml).', 'armGroupLabels': ['bupivacaine-calcitonin-fentanyl group']}, {'name': 'Bupivacaine-fentanyl', 'type': 'DRUG', 'description': 'pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.', 'armGroupLabels': ['bupivacaine-fentanyl group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After completion of the study', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request from the corresponding author', 'accessCriteria': 'The data will be available upon reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university', 'investigatorFullName': 'Osama Rehab', 'investigatorAffiliation': 'Tanta University'}}}}