Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:13 AM
Study NCT ID:
NCT07335250
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study is triple-blinded. Neither the participants, the block performer, nor the outcome assessors are aware of the group assignments. Randomization codes are stored centrally, and a separate staff member who is not involved in patient care or outcome assessment prepares the study solutions and labels them in an identical manner to maintain allocation concealment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into two parallel groups to receive either an ultrasound-guided intertransverse process block with bupivacaine or a placebo saline injection at the same site. Each participant will receive only one intervention, and postoperative outcomes will be compared between the two groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Consumption Within the First 24 Hours After Surgery', 'timeFrame': '24 hours postoperatively', 'description': 'The primary objective of the study is to evaluate the effect of the intertransverse process block (ITPB) on opioid consumption within the first 24 hours postoperatively in patients undergoing thoracotomy with unilateral lobectomy. Morphine consumption will be determined based on patient-controlled analgesia (PCA) use.'}], 'secondaryOutcomes': [{'measure': 'NRS score', 'timeFrame': '0 to 24 hours postoperatively', 'description': 'After extubation, patients will be assessed at 0, 6, 12, and 24 hours for pain intensity both at rest and during coughing using the Numeric Rating Scale (NRS; 0-10).\n\nThe Numeric Rating Scale ranges from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating worse pain severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intertransverse Process Block', 'Thoracotomy Lobectomy', 'Acute Postoperative Pain'], 'conditions': ['Acute Postoperative Pain', 'Thoracotomy Surgery', 'Intertransverse Process Block']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, triple-blind, placebo-controlled clinical trial will investigate the effectiveness of the intertransverse process block (ITPB) for postoperative analgesia in patients undergoing elective thoracotomy with unilateral lobectomy. The study will be conducted at a single tertiary center in accordance with the principles of the Declaration of Helsinki, and written informed consent will be obtained from all participants.\n\nPatients will be randomized in a 1:1 ratio to receive either ultrasound-guided ITPB with 0.5% bupivacaine or placebo (normal saline) prepared in identical syringes to ensure allocation concealment. The block will be performed by an experienced anesthesiologist immediately after surgery and before emergence from anesthesia. Both groups will receive standardized general anesthesia, multimodal perioperative analgesia, and postoperative intravenous morphine patient-controlled analgesia (PCA).\n\nThe trial aims to evaluate the analgesic efficacy and opioid-sparing effect of ITPB while maintaining safety and adherence to routine clinical practice. Outcomes will include postoperative pain scores, opioid consumption, rescue analgesia requirement, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent\n\nAge between 18 and 85 years\n\nASA Physical Status classification I-III\n\nElective thoracotomy with planned unilateral lobectomy\n\nAnticipated hospital stay of at least one night\n\nExpected requirement for parenteral opioid analgesia for at least 24 hours postoperatively\n\nAbility to operate an intravenous patient-controlled analgesia (PCA) device\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery\n\nPresence of infection or open wound at the injection site\n\nCoagulopathy\n\nHepatic or renal failure\n\nPatients undergoing reoperation\n\nPatients with missing or incomplete data\n\nPregnancy or lactation\n\nTracheal malformation or tracheostomy\n\nChronic opioid use (≥30 days within the last 3 months, ≥15 mg/day morphine equivalent)\n\nPatients exceeding the maximum safe local anesthetic dose based on weight (2.5 mg/kg, max 150 mg)\n\nPatients who refuse data privacy consent will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT07335250', 'briefTitle': 'Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy', 'organization': {'class': 'OTHER', 'fullName': 'Konya City Hospital'}, 'officialTitle': 'Postoperative Pain Control With Intertransverse Process Block in Patients Undergoing Thoracotomy With Lobectomy', 'orgStudyIdInfo': {'id': '2025/485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Block Group - Intertransverse Process Block', 'interventionNames': ['Procedure: Intertransverse Process Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group - Placebo:', 'interventionNames': ['Procedure: Placebo']}], 'interventions': [{'name': 'Intertransverse Process Block', 'type': 'PROCEDURE', 'description': 'The block will be performed under ultrasound guidance by the same anesthesiologist with more than five years of experience, immediately after surgery and before emergence from anesthesia. Patients will be placed in the lateral decubitus position with the operative side uppermost and the skin prepared.\n\nUsing a high-frequency linear probe (Mindray DC-60 Exp), the T5 spinous process will be identified at the midline, then the probe will be moved approximately 2 cm laterally to visualize the superior costotransverse ligament (SCTL) and pleura. The needle will be advanced in-plane in a caudal-to-cranial direction toward the cranial border of the fourth rib. After confirmation of correct spread by hydrodissection, 20 mL of 0.5% bupivacaine will be injected.', 'armGroupLabels': ['Block Group - Intertransverse Process Block']}, {'name': 'Placebo', 'type': 'PROCEDURE', 'description': 'In the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic.', 'armGroupLabels': ['Control Group - Placebo:']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Omer Keklicek, Principal Investigator', 'role': 'CONTACT', 'email': 'hastane@erbakan.edu.tr', 'phone': '+90 332 223 70 00'}], 'facility': 'Konya City Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'centralContacts': [{'name': 'Omer Keklicek, Principal Investigator', 'role': 'CONTACT', 'email': 'drokeklicek@gmail.com', 'phone': '+905399291702'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ömer Keklicek', 'investigatorAffiliation': 'Konya City Hospital'}}}}