Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT06210958
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2023-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single- Vs. Triple-Injection Techniques for Intertransverse Process Blocks in Video-Assisted Thoracoscopic Surgery: a Randomized Trial on Sensory Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be divided into 2 groups: single injection of intertransverse process block and triple injection of intertransverse process block'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the distribution of cutaneous block after the inter transverse process block and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy', 'timeFrame': 'at 1 hour after the end of surgery', 'description': "the distribution of cutaneous block is the cutaneous sensory distribution of dermatomes involvement by the intertransverse process block. A cutaneous sensory distribution is defined as an area of reduced sensitivity to cold touch as compare to the abdomen which participants know as 'normal'. The assessment begins at the mid-clavicular line on the block side, processing laterally to the posterior axillary line on the chest wall and apex of axilla (between T2-T10 dermatomes) at about 1-cm intervals, bilaterally."}], 'secondaryOutcomes': [{'measure': 'To compare pain intensity using numerical rating scale during the first 24-hours postoperative period after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy', 'timeFrame': '24 hour after surgery', 'description': 'The numerical rating scale is a pain scales using numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain.'}, {'measure': 'To compare opioids consumption during the intraoperative and the first 24-hours postoperative period after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy', 'timeFrame': '24 hour after surgery'}, {'measure': 'To compare adverse complication (pneumothorax, hemothorax) after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy', 'timeFrame': '24 hour after intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intertransverse Process Block', 'Video Assisted Thoracic Surgery']}, 'referencesModule': {'references': [{'pmid': '32008623', 'type': 'BACKGROUND', 'citation': 'Bade BC, Dela Cruz CS. Lung Cancer 2020: Epidemiology, Etiology, and Prevention. Clin Chest Med. 2020 Mar;41(1):1-24. doi: 10.1016/j.ccm.2019.10.001.'}, {'pmid': '32734596', 'type': 'BACKGROUND', 'citation': 'Sihoe ADL. Video-assisted thoracoscopic surgery as the gold standard for lung cancer surgery. Respirology. 2020 Nov;25 Suppl 2:49-60. doi: 10.1111/resp.13920. Epub 2020 Jul 30.'}, {'pmid': '29700092', 'type': 'BACKGROUND', 'citation': 'Jones GS, Baldwin DR. Recent advances in the management of lung cancer. Clin Med (Lond). 2018 Apr 1;18(Suppl 2):s41-s46. doi: 10.7861/clinmedicine.18-2-s41.'}, {'pmid': '32593366', 'type': 'BACKGROUND', 'citation': 'Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.'}, {'pmid': '32765060', 'type': 'BACKGROUND', 'citation': 'Tong Y, Wei P, Wang S, Sun Q, Cui Y, Ning N, Chen S, He X. Characteristics of Postoperative Pain After VATS and Pain-Related Factors: The Experience in National Cancer Center of China. J Pain Res. 2020 Jul 21;13:1861-1867. doi: 10.2147/JPR.S249134. eCollection 2020.'}, {'pmid': '32221089', 'type': 'BACKGROUND', 'citation': 'Takenaka S, Saeki A, Sukenaga N, Ueki R, Kariya N, Tatara T, Hirose M. Acute and chronic neuropathic pain profiles after video-assisted thoracic surgery: A prospective study. Medicine (Baltimore). 2020 Mar;99(13):e19629. doi: 10.1097/MD.0000000000019629.'}, {'pmid': '35236334', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Zhou R, Hou B, Tang S, Hao J, Gu X, Ma Z, Zhang J. Incidence and risk factors for chronic postsurgical pain following video-assisted thoracoscopic surgery: a retrospective study. BMC Surg. 2022 Mar 2;22(1):76. doi: 10.1186/s12893-022-01522-1.'}, {'pmid': '35251576', 'type': 'BACKGROUND', 'citation': 'Peng J, Wang Z, Ma L, Ma W, Liu G, Zhang H, Wang Q, Zhu B, Zhao L. Incidence and Influencing Factors of Chronic Postthoracotomy Pain in Lung Tumor Patients. J Healthc Eng. 2022 Feb 24;2022:7584481. doi: 10.1155/2022/7584481. eCollection 2022.'}, {'pmid': '29445595', 'type': 'BACKGROUND', 'citation': 'Piccioni F, Ragazzi R. Anesthesia and analgesia: how does the role of anesthetists changes in the ERAS program for VATS lobectomy. J Vis Surg. 2018 Jan 11;4:9. doi: 10.21037/jovs.2017.12.11. eCollection 2018.'}, {'pmid': '32755088', 'type': 'BACKGROUND', 'citation': "Bugada D, Lorini LF, Lavand'homme P. Opioid free anesthesia: evidence for short and long-term outcome. Minerva Anestesiol. 2021 Feb;87(2):230-237. doi: 10.23736/S0375-9393.20.14515-2. Epub 2020 Aug 4."}, {'pmid': '29985526', 'type': 'BACKGROUND', 'citation': 'Nafziger AN, Barkin RL. Opioid Therapy in Acute and Chronic Pain. J Clin Pharmacol. 2018 Sep;58(9):1111-1122. doi: 10.1002/jcph.1276. Epub 2018 Jul 9.'}, {'pmid': '34724195', 'type': 'BACKGROUND', 'citation': 'Olausson A, Svensson CJ, Andrell P, Jildenstal P, Thorn SE, Wolf A. Total opioid-free general anaesthesia can improve postoperative outcomes after surgery, without evidence of adverse effects on patient safety and pain management: A systematic review and meta-analysis. Acta Anaesthesiol Scand. 2022 Feb;66(2):170-185. doi: 10.1111/aas.13994. Epub 2021 Nov 11.'}, {'pmid': '34739134', 'type': 'BACKGROUND', 'citation': 'Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.'}, {'pmid': '35463038', 'type': 'BACKGROUND', 'citation': 'Lin J, Liao Y, Gong C, Yu L, Gao F, Yu J, Chen J, Chen X, Zheng T, Zheng X. Regional Analgesia in Video-Assisted Thoracic Surgery: A Bayesian Network Meta-Analysis. Front Med (Lausanne). 2022 Apr 6;9:842332. doi: 10.3389/fmed.2022.842332. eCollection 2022.'}, {'pmid': '9813528', 'type': 'BACKGROUND', 'citation': 'Richardson J, Lonnqvist PA. Thoracic paravertebral block. Br J Anaesth. 1998 Aug;81(2):230-8. doi: 10.1093/bja/81.2.230. No abstract available.'}, {'pmid': '35089532', 'type': 'BACKGROUND', 'citation': 'Sharma R, Louie A, Thai CP, Dizdarevic A. Chest Wall Nerve Blocks for Cardiothoracic, Breast Surgery, and Rib-Related Pain. Curr Pain Headache Rep. 2022 Jan;26(1):43-56. doi: 10.1007/s11916-022-01001-5. Epub 2022 Jan 28.'}, {'pmid': '35368174', 'type': 'BACKGROUND', 'citation': 'Kim SH. Anatomical classification and clinical application of thoracic paraspinal blocks. Korean J Anesthesiol. 2022 Aug;75(4):295-306. doi: 10.4097/kja.22138. Epub 2022 Apr 4.'}, {'pmid': '26897642', 'type': 'BACKGROUND', 'citation': 'Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.'}, {'pmid': '24565302', 'type': 'BACKGROUND', 'citation': 'Junior Ade P, Erdmann TR, Santos TV, Brunharo GM, Filho CT, Losso MJ, Filho GR. Comparison between continuous thoracic epidural and paravertebral blocks for postoperative analgesia in patients undergoing thoracotomy: Systematic review. Braz J Anesthesiol. 2013 Sep-Oct;63(5):433-42. doi: 10.1016/j.bjane.2013.10.002. Epub 2013 Nov 19.'}, {'pmid': '35021139', 'type': 'BACKGROUND', 'citation': 'Cho TH, Kwon HJ, O J, Cho J, Kim SH, Yang HM. The pathway of injectate spread during thoracic intertransverse process (ITP) block: Micro-computed tomography findings and anatomical evaluations. J Clin Anesth. 2022 May;77:110646. doi: 10.1016/j.jclinane.2022.110646. Epub 2022 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'The intertransverse process block (ITPB) is an alternatives technique of regional anesthesia for thoracic surgery. However, the precise technique of ITPB remains developing. This study aims to evaluate the efficacy of ITPB injections which are single and triple injection in adult-patients undergoing video-assisted thoracoscopic surgery. The investigators hypothesize that cutaneous sensory block and perioperative pain outcomes including pain intensity and opioids consumption in patients who received triple injections of ITPB are better than that of single injection.', 'detailedDescription': 'Objectives: evaluate the efficacy of single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for pulmonary resection Setting: Single center tertiary teaching hospital Participants: adult-patients who undergoing scheduled video-assisted thoracoscopic surgery for pulmonary resection.\n\nIntervention: The patient will divide to 2 groups of intervention: single injection of ITPB (S-group) and triple injection of ITPB (T-group). The ITPB will be perform after routine general anesthesia. The primary outcomes is to compare the distribution of cutaneous block after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for pulmonary resection. The distribution of cutaneous block will be evaluate at PACU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged 20-70 years old\n2. Undergoing scheduled the first time for each side of video-assisted thoracoscopic surgery (VATS) for pulmonary resection\n3. American Society of Anesthesia (ASA) physical status I-III\n4. Patients have ability to communicate and understand the study and accept to participate in study\n5. Body weight \\>40 kg\n\nExclusion Criteria:\n\n1. Patients who allergic to bupivacaine, lidocaine, NSAIDS, paracetamol, and dexamethasone\n2. Patients who have following underlying disease: renal impairment (diagnosed of end-stage renal disease (ESRD) or chronic kidney disease (CKD) which estimated glomerular filtration rate (eGFR) \\< 60 ml/min per 1.73 square meters) , hepatic impairment (diagnosed of cirrhosis or evidence of abnormal liver function test which are increased liver enzymes or bilirubin level), coagulopathy (diagnosed of disease associated with abnormal coagulation, currently use any anticoagulants or evidence of prolong prothrombin time (PT) or partial thromboplastin time (PTT)), thrombocytopenia (platelet count less than 150,000/microliter), platelet disfunction from any causes such as current use antiplatelet or uremia (BUN level \\> 60 mg/dL) , morbid obesity (BMI \\>40 kg/m2), pre-existing neurological deficits, chronic pain (diagnosed of chronic pain disease or current use regular analgesic drugs), or any drug addiction • Withdrawal criteria: a participant will be withdrawn from the study in case of\n\n1\\. Procedural failure: the operator cannot place the needle tip in the intertransverse tissue according to the technical difficulty or abnormal anatomy after 15 minutes of performing the block (from the beginning of needle insertion to the injection of local anesthetic) 2. Anesthetic related events including cardiac arrest, difficult intubation 3. Surgical related events including massive bleeding, major organ injury, converted operation to open thoracotomy and reoperation within admission 4. Participant related reasons including patient's willing to withdraw from the study or failure to adhere adequately to protocol requirements such as premature discharge. However, the withdrawn participant will be continued follow up of clinical outcome."}, 'identificationModule': {'nctId': 'NCT06210958', 'briefTitle': 'Single- Vs. Triple-Injection Techniques for Intertransverse Process Blocks in Video-Assisted Thoracoscopic Surgery: a Randomized Trial on Sensory Blockade', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'A Randomized Comparison of Cutaneous Sensory Blockade Between Ultrasound Guided Single and Triple Injections of Intertransverse Process Block in Patients Undergoing Video Assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': 'ANE-2566-0137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-group', 'description': 'Single injection of ITPB at T4-5 level', 'interventionNames': ['Other: Intertransverse process block']}, {'type': 'EXPERIMENTAL', 'label': 'T-group', 'description': 'Triple injection of ITPB at T3-4, T4-5, T5-6 levels', 'interventionNames': ['Other: Intertransverse process block']}], 'interventions': [{'name': 'Intertransverse process block', 'type': 'OTHER', 'description': 'The patients will be randomized into 2 groups which will receive the different techniques of the intertransverse process block', 'armGroupLabels': ['S-group', 'T-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of Anesthesiology', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Kittitorn Supphapipat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicaine, Chaing Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The IPD will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-investigator, Department of Anesthesiology', 'investigatorFullName': 'Kittitorn Supphapipat', 'investigatorAffiliation': 'Chiang Mai University'}}}}