Ignite Creation Date:
2025-12-25 @ 2:57 AM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT06851533
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Thoracolumbar Interfascial and Quadro Iliac Plane Blocks on Postoperative Opioid Use Following Lumbar Microsurgery
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': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tramadol consumption', 'timeFrame': 'first 24 hours after the operation', 'description': 'Total tramadol consumption (mg) in the first 24 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'NRS (Numerical Rating Scale) pain scores', 'timeFrame': 'first 24 hours after the operation', 'description': 'NRS (0-10) scores will be measured at 3, 6, 12, 18, and 24 hours during both rest and mobilization in the postoperative period.'}, {'measure': 'opioid-related side effects (such as nausea, vomiting, respiratory depression)', 'timeFrame': 'first 24 hours after the operation', 'description': 'The incidence of opioid-related side effects (e.g., nausea, vomiting, respiratory depression) will be recorded and compared between groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Ultrasound-guided nerve block'], 'conditions': ['Lumbar Microdiscectomy', 'Nerve Block']}, 'referencesModule': {'references': [{'pmid': '38068268', 'type': 'BACKGROUND', 'citation': 'Canikli Adiguzel S, Akyurt D, Bahadir Altun H, Ultan Ozgen G, Akdeniz S, Bayraktar B, Tulgar S, Yigit Y. Posterior Quadratus Lumborum Block or Thoracolumbar Interfascial Plane Block and Postoperative Analgesia after Spinal Surgery: A Randomized Controlled Trial. J Clin Med. 2023 Nov 21;12(23):7217. doi: 10.3390/jcm12237217.'}, {'pmid': '34704718', 'type': 'BACKGROUND', 'citation': 'Hu Z, Han J, Jiao B, Jiang J, Sun Y, Lv Z, Wang J, Tian X, Wang H. Efficacy of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Meta-analysis of Randomized Clinical Trials. Pain Physician. 2021 Nov;24(7):E1085-E1097.'}, {'pmid': '38915966', 'type': 'BACKGROUND', 'citation': 'Yildirim Uslu E. Effect of Quadratus Lumborum Block in Patients With Acute-Subacute Unilateral Lumbar Strain. Cureus. 2024 May 24;16(5):e61014. doi: 10.7759/cureus.61014. eCollection 2024 May.'}]}, 'descriptionModule': {'briefSummary': 'Lumbar microdiscectomy is a commonly used surgical procedure for treating herniated discs. Effective postoperative analgesia is crucial for early mobilization and functional recovery. Uncontrolled postoperative pain can delay recovery, increase the risk of opioid dependence, and lead to respiratory complications.\n\nAlthough opioid analgesics effectively reduce pain, they can cause side effects such as nausea, vomiting, respiratory depression, and dependency. Therefore, non-opioid analgesic methods are preferred for patient safety and comfort. Recently, regional anesthesia techniques such as the Thoracolumbar Interfascial Plane (TLIP) block and the Quadro Iliac Plane Block have been introduced for postoperative pain management in lumbar surgeries. However, there are not enough studies comparing the superiority of these two methods.\n\nStudy Objective: The primary aim of this study is to evaluate the effects of ultrasound-guided TLIP and Quadro Iliac Plane Blocks on postoperative opioid consumption after lumbar microsurgery. The secondary aim is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression, etc.) and postoperative NRS pain scores between the groups.', 'detailedDescription': "Lumbar microdiscectomy is a widely performed surgical procedure for the treatment of lumbar disc herniation. Ensuring optimal analgesia during the postoperative period is crucial for promoting functional recovery and early mobilization. Inadequate control of postoperative pain may delay the healing process, increase the risk of opioid dependence, and lead to respiratory complications.\n\nAlthough opioid analgesics are effective in alleviating pain during the postoperative period, they can cause adverse effects such as nausea, vomiting, respiratory depression, and an increased risk of dependence. Therefore, the implementation of non-opioid analgesic strategies is essential for maintaining patient safety and comfort. In recent years, regional anesthesia techniques, including the Thoracolumbar Interfascial Plane block and the Quadro Iliac Plane Block, have been utilized for postoperative pain management in lumbar surgeries. However, there is insufficient evidence directly comparing the effectiveness of these two methods.\n\nPurpose of the Study: The primary objective of this study is to evaluate the impact of ultrasound-guided Thoracolumbar Interfascial Plane and Quadro Iliac Plane Blocks on postoperative opioid consumption following lumbar microsurgery. Additionally, the secondary objective is to compare the incidence of opioid-related side effects (such as nausea, vomiting, and respiratory depression) and patients' postoperative pain scores, measured using the Numeric Rating Scale, between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 80 years\n* American Society of Anesthesiologists (ASA) physical status I to III\n* scheduled for lumbar microdiscectomy surgery\n\nExclusion Criteria:\n\n* Known allergy to local anesthetics\n* Any other significant drug allergies related to the study interventions\n* Pregnancy\n* Pre-existing psychiatric or neurological disorders\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06851533', 'briefTitle': 'Comparing Thoracolumbar Interfascial and Quadro Iliac Plane Blocks on Postoperative Opioid Use Following Lumbar Microsurgery', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Comparison of the Effects of Thoracolumbar Interfascial Plane Block and Quadro Iliac Plane Block on Postoperative Opioid Consumption After Lumbar Microsurgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Lumbar tlip vs quadroilaac'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No Block (Control Group)', 'description': 'Patients receive standard perioperative analgesia without any additional regional block.', 'interventionNames': ['Procedure: Standard Analgesia (No Block)']}, {'type': 'EXPERIMENTAL', 'label': 'TLIP Block', 'description': 'Patients receive the Thoracolumbar Interfascial Plane (TLIP) block in addition to standard perioperative analgesia.', 'interventionNames': ['Procedure: Thoracolumbar Interfascial Plane (TLIP) Block']}, {'type': 'EXPERIMENTAL', 'label': 'Quadro Iliac Plane Block', 'description': 'Patients receive the Quadro Iliac Plane Block in addition to standard perioperative analgesia.', 'interventionNames': ['Procedure: Quadro Iliac Plane Block']}], 'interventions': [{'name': 'Standard Analgesia (No Block)', 'type': 'PROCEDURE', 'description': 'Participants receive standard perioperative analgesia (including intravenous paracetamol/tramadol), but no additional regional block is applied.', 'armGroupLabels': ['No Block (Control Group)']}, {'name': 'Thoracolumbar Interfascial Plane (TLIP) Block', 'type': 'PROCEDURE', 'description': 'In addition to standard perioperative analgesia, a TLIP block is performed under sterile conditions and ultrasound guidance, after the surgical procedure is completed but before the patient is awakened. A total of 20 mL of 0.25% bupivacaine is injected into the thoracolumbar fascial plane, and spread is confirmed via ultrasound.', 'armGroupLabels': ['TLIP Block']}, {'name': 'Quadro Iliac Plane Block', 'type': 'PROCEDURE', 'description': 'In addition to standard perioperative analgesia, a Quadro Iliac Plane Block is performed under sterile conditions and ultrasound guidance, after the surgical procedure is completed but before the patient is awakened. A total of 20 mL of 0.25% bupivacaine is injected into the quadro iliac plane at the level of the iliac crest, and spread is confirmed via ultrasound.', 'armGroupLabels': ['Quadro Iliac Plane Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Burak Ömür', 'role': 'CONTACT', 'email': 'burakomur@outlook.com', 'phone': '+905056215056'}], 'facility': 'Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Burak Ömür', 'role': 'CONTACT', 'email': 'burakomur@outlook.com', 'phone': '+905056215056'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'only IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Burak Omur', 'investigatorAffiliation': 'Medipol University'}}}}