Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06838793
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ITPB 1 vs 3 in VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of recovery', 'timeFrame': 'At 24 hours post surgery', 'description': 'Comparing the quality of recovery 15 (QoR15) score at 24 hours between the study groups. QoR15: a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery)'}], 'secondaryOutcomes': [{'measure': 'Area under the curve for pain at rest and movement (deep breathing)', 'timeFrame': 'Over the first 24 hours after surgery', 'description': 'Comparing the area under the curve (AUC) of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing (pain burden).'}, {'measure': 'Number of hypoesthetic and anaesthetic dermatomes', 'timeFrame': 'At 15 and 30 minutes after block completion', 'description': 'Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax'}, {'measure': 'Rescue fentanyl and phenylephrine administration', 'timeFrame': 'Intraoperative', 'description': 'Total rescue fentanyl and phenylephrine administration'}, {'measure': 'Postoperative morphine, tramadol and ondansetron consumption', 'timeFrame': 'At 24 and 48 hour post sugery', 'description': 'Total postoperative morphine, tramadol and ondansetron consumption'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intertransverse Process Block', 'Video-assisted Thoracscopic Surgery', 'Quality of Recovery'], 'conditions': ['Musculoskeletal Diseases or Conditions']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the quality of recovery after video-assisted thoracoscopic surgery (VATS) by comparing the efficacy of a single-level intertransverse process block (ITPB) against a three-level ITPB, with particular attention to the quality of recovery measured by the QoR15 score at 24 hours post-surgery.', 'detailedDescription': 'Video-assisted thoracoscopic surgeries (VATS) are currently the preferred technique for treating carcinoma lung. Despite being minimally invasive, VATS is associated with significant acute and chronic postoperative pain. Regional anesthetic techniques have the potential to block afferent nociception at the peripheral nerve level, the dorsal root ganglion (DRG), the thoracic sympathetic ganglion, or through a combination of these mechanisms. While the peripheral nerve block techniques such as the intercostal nerve block and serratus anterior plane block can provide analgesia for port related somatic pain, the visceral pain mediated via the thoracic sympathetic chain during VATS procedure are amenable only to epidural or paravertebral regional anaesthetic techniques. The thoracic paravertebral block (TPVB) provides ipsilateral, segmental, somatic, and sympathetic nerve blockade across multiple contiguous thoracic dermatomes and is currently the first choice for VATS. During a TPVB, the local anaesthetic (LA) is injected into the paravertebral space adjacent to the thoracic vertebra, near the intervertebral foramen.\n\nTraditionally, TPVB is performed using either landmark or ultrasound guidance, with the LA deposited anterior to the superior costotransverse ligament (SCTL). This typically involves the block needle piercing the SCTL to reach the wedge-shaped TPVB space. While Thoracic Paravertebral Block (TPVB) is generally regarded as safe, the proximity of the needle tip to the pleura during injection poses a heightened risk of pleural puncture and pneumothorax, especially when administered by less experienced physicians. Consequently, the Erector Spinae Plane Block (ESPB) is gaining popularity as an alternative. However, it is important to note that ESPB also has its own limitations.\n\nRecent advancements have redefined thoracic paravertebral anatomy, identifying a fat-filled retro-SCTL space located behind the SCTL. This space is farther from the pleura but remains in close proximity to anterior neural targets such as the thoracic spinal nerve, the DRG and thoracic sympathetic ganglion. It is hypothesised that an LA injection into the retro-SCTL space-referred to as the Intertransverse Process Block (ITPB) at the medial retro SCTL space-could produce a rapid onset of ipsilateral and/or bilateral segmental somatic and sympathetic nerve blockade of the thoracic dermatomes without the need to pierce the SCTL, thereby reducing the risk of pleural puncture and pneumothorax. Preliminary investigations on the ITPB for VATS is promising, however, there is a paucity of data on the effect of the number of injections following an ultrasound-guided (USG) ITPB on the analgesic efficacy, which this study aims to evaluate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients\n* 18 to 80 years of age\n* Patients with primary carcinoma lung scheduled for resection under VATS procedure\n\nExclusion Criteria:\n\n* Patient refusal\n* Local skin infection at the area of injection\n* Coagulopathy\n* History of allergy to local anaesthetics'}, 'identificationModule': {'nctId': 'NCT06838793', 'briefTitle': 'ITPB 1 vs 3 in VATS', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Quality of Recovery After Video-assisted Thoracoscopic Surgery: A Prospective, Randomised, Double-Blinded Trial Comparing Single and Three Level Intertransverse Process Block.', 'orgStudyIdInfo': {'id': '2025.547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single Level Intertransverse Process Block', 'description': 'Patients with primary carcinoma lung scheduled for resection under VATS procedure and randomized in SL group will receive a single level ITPB at retro SCTL space injection and it will be performed at T5 vertebral level after which two subsequent IM sham injections with 2-3 ml 0.9% saline will be performed at T3 and T7 level.', 'interventionNames': ['Procedure: Single Level Intertransverse Process Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Three Level Intertransverse Process Block', 'description': 'Patients with primary carcinoma lung scheduled for resection under VATS procedure and randomized in TL group will receive injection at T3, T5 and T7.', 'interventionNames': ['Procedure: Three Level Intertransverse Process Block']}], 'interventions': [{'name': 'Single Level Intertransverse Process Block', 'type': 'PROCEDURE', 'description': 'Patients will then be positioned in the lateral decubitus position with the side to be blocked facing upwards, the neck slightly flexed and the upper arm resting on the pillow for the USG ITPB.\n\nThe thoracic intervertebral levels (T3, T5, T7) will be identified and marked on the patient. Ultrasound gel will be applied to the skin foracoustic coupling and the transducer is placed 2-3 cm lateral to the spinous process, at the target vertebral level, in the t After obtaining the target transverse ultrasound window at the articular process level, under strict aseptic precautions and local infiltration (Lignocaine 1%), a SonoTap nerve block needle (Pajunk, 22G, 80 mm, Pajunk, Geisingen, Germany) will be inserted in-plane and slowly advanced from a lateral to medial direction until its tip is located at the medial aspect of the retro-SCTL space. After negative heme aspiration, 25 ml of LA mixture containing 0.5% ropivacaine with 1: 200,000 adrenaline will be injected slowly in small aliquots.', 'armGroupLabels': ['Single Level Intertransverse Process Block']}, {'name': 'Three Level Intertransverse Process Block', 'type': 'PROCEDURE', 'description': 'Patients will then be positioned in the lateral decubitus position with the side to be blocked facing upwards, the neck slightly flexed and the upper arm resting on the pillow for the USG ITPB. After obtaining the target transverse ultrasound window at the inferior articular process level (described above) at the T7 level, under strict aseptic precautions and local infiltration (Lignocaine 1%), a SonoTap nerve block needle (Pajunk, 22G, 80 mm, Pajunk, Geisingen, Germany) will be inserted in-plane and slowly advanced from a lateral to medial direction until its tip is located at the medial aspect of the retro-SCTL space. After negative heme aspiration, 8 ml of LA mixture containing 0.5% ropivacaine with 1:200,000 adrenaline will be injected slowly in small aliquots. Subsequently, similar injections will be performed at T5 and T3 level with 8 ml and 9 ml LA mixture, respectively (Total LA mixture volume: 25 ml).', 'armGroupLabels': ['Three Level Intertransverse Process Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Territories', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Ayla Wong, RN, BN', 'role': 'CONTACT', 'email': 'aylawong@cuhk.edu.hk', 'phone': '+852 55696157'}], 'facility': 'Department of Anaesthesia, Pain and Perioperative Medicine, Prince of Wales Hospital, Shatin', 'geoPoint': {'lat': 22.42441, 'lon': 114.11095}}], 'centralContacts': [{'name': 'Ayla Wong, RN, BN', 'role': 'CONTACT', 'email': 'aylawong@cuhk.edu.hk', 'phone': '+852 55696157'}, {'name': 'Manoj K Karmakar, MD, FRCA', 'role': 'CONTACT', 'email': 'karmakar@cuhk.edu.hk'}], 'overallOfficials': [{'name': 'Manoj K Karmakar, MD, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof Manoj K Karmakar', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}