Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT04920994
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Major Abdominal Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total analgesic requirements of morphine', 'timeFrame': 'Up to 24 hours after the procedure', 'description': 'The amount of morphine consumption in milligrams given as a rescue analgesia'}], 'secondaryOutcomes': [{'measure': 'Improvement in pain scores by Visual analogue scale (VAS)', 'timeFrame': 'Up to 24 hours after the procedure', 'description': 'VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed postoperatively at 1, 2, 4, 8, 12, 24 hours'}, {'measure': 'Duration for the first analgesic request', 'timeFrame': 'Up to 24 hours after the procedure', 'description': 'The time of the first analgesic request for morphine in minutes will be recorded.'}, {'measure': 'Changes in heart rate', 'timeFrame': 'Up to 24 hours after the procedure', 'description': 'Heart rate (beat/min) will be recorded at baseline, intraoperative fifteen-minute intervals, 1, 2, 4, 8, 12, 24 hours postoperatively'}, {'measure': 'Changes in mean arterial blood pressure', 'timeFrame': 'Up to 24 hours after the procedure', 'description': 'Blood pressure (mmHg) will be recorded at baseline,intraoperative fifteen-minute intervals,1, 2, 4, 8, 12, 24 hours postoperatively'}, {'measure': 'Incidence of adverse effects', 'timeFrame': 'Up to 24 hours after the procedure', 'description': 'Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, pruritus, hematoma, or allergic reactions will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracoabdominal nerve block'], 'conditions': ['Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block.\n\nIt is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.', 'detailedDescription': 'Postoperative pain management for major abdominal surgeries can reduce postoperative respiratory dysfunction and promote early mobilization. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. As such, outcomes associated with the transverse abdominis plane block are of increasing interest. A modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) is a novel analgesic technique that involves local anesthetic injection into the lower aspect of the chondrium. It can block thoracoabdominal nerves at T5 in cephalic direction and down to T11-T12 in caudal direction and may be an effective analgesic for major abdominal surgeries.\n\nThe aim of this study is to assess the quality of pain relief in patients who will undergo major abdominal surgery receiving either (M-TAPA) block or (SCTAP) block by comparing and evaluating the differences between the two techniques.\n\nThis prospective, randomized, comparative clinical study will include 80 patients who will be scheduled for major abdominal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. Eligible patients will be randomly assigned to 2 equal groups (M-TAPA group and SCTAP group) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiology (ASA) I and II patients.\n* Scheduled for elective major abdominal surgeries.\n\nExclusion Criteria:\n\n* Patient's refusal.\n* Altered mental status or un-cooperative patients.\n* History of known sensitivity to the used anesthetics.\n* Bleeding or coagulation diathesis.\n* Infection at the injection site."}, 'identificationModule': {'nctId': 'NCT04920994', 'briefTitle': 'Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Major Abdominal Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Comparison to Subcostal Transverse Abdominis Plane Block (TAP) in Major Abdominal Surgeries', 'orgStudyIdInfo': {'id': 'Modified TAPA Block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (M-TAPA )', 'description': 'Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.', 'interventionNames': ['Procedure: M-TAPA block', 'Drug: Bupivacaine Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (SCTAP)', 'description': 'Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.', 'interventionNames': ['Procedure: SCTAP block', 'Drug: Bupivacaine Hydrochloride']}], 'interventions': [{'name': 'M-TAPA block', 'type': 'PROCEDURE', 'otherNames': ['Ultrasound guided block'], 'description': 'A high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.', 'armGroupLabels': ['Group A (M-TAPA )']}, {'name': 'SCTAP block', 'type': 'PROCEDURE', 'otherNames': ['Ultrasound guided block'], 'description': 'A high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side.', 'armGroupLabels': ['Group B (SCTAP)']}, {'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': '20 ml 0.25% bupivacaine will be injected after the negative aspiration test.', 'armGroupLabels': ['Group A (M-TAPA )', 'Group B (SCTAP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Department of Anesthesia, Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Sameh M El-Sherbiny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sameh Fathy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia, ICU & pain management; Faculty of Medicine', 'investigatorFullName': 'Sameh Fathy', 'investigatorAffiliation': 'Mansoura University'}}}}