Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-30 @ 7:52 PM
Study NCT ID:
NCT04575233
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2020-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001733', 'term': 'Bites and Stings'}], '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'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'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', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioids consumption', 'timeFrame': '24 hours from surgery', 'description': 'Opioid consumption measured in morphine milligram equivalents (MME) per day'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption within the first 48 hours after the operation', 'timeFrame': '48 hours from surgery', 'description': 'Opioid consumption measured in morphine milligram equivalents (MME) per day'}, {'measure': 'postoperative pain', 'timeFrame': 'at 3, 6, 12, 24 hours from surgery', 'description': 'Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 24 hours. This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.'}, {'measure': 'length of hospital stay', 'timeFrame': 'during hospitalization,approximately 6 days', 'description': 'number of days the participant is being hospitalized'}, {'measure': 'Time required to perform the (Transversus Abdominis Plane) TAP block', 'timeFrame': 'during procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transversus Abdominis Plane (TAP) Block', 'Local Anesthetic Infiltrations'], 'conditions': ['Laparoscopic Colectomy', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '37525414', 'type': 'DERIVED', 'citation': 'La Regina D, Popeskou SG, Saporito A, Gaffuri P, Tasciotti E, Dossi R, Christoforidis D, Mongelli F. Laparoscopic versus ultrasound-guided transversus abdominis plane block in colorectal surgery: a non-inferiority, multicentric randomized double-blinded clinical trial. Colorectal Dis. 2023 Sep;25(9):1921-1928. doi: 10.1111/codi.16689. Epub 2023 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the postoperative pain, the time needed and other clinical outcomes in patients who, during laparoscopic colectomy, will be injected with a local anesthetic (Ropivacaine) through an ultrasound guided technique performed by the anaesthesiologist or throught a laparoscopic assisted technique performed by the surgeon'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients candidates to laparoscopic colorectal surgery\n* Signed informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Pregnancy\n* Allergy to local anaesthetics\n* Spinal or epidural analgesia\n* Acute inflammatory abdominal pathologies\n* Chronic pain syndrome\n* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDS)'}, 'identificationModule': {'nctId': 'NCT04575233', 'briefTitle': 'A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Cantonale, Bellinzona'}, 'officialTitle': 'Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TAP block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Transversus Abdominis Plane (L-TAP) group', 'description': 'Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under laparoscopic control', 'interventionNames': ['Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block', 'Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound Transversus Abdominis Plane (U-TAP) group', 'description': 'Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under ultrasound control', 'interventionNames': ['Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block', 'Drug: Ropivacaine']}], 'interventions': [{'name': 'laparoscopic-assisted Transversus Abdominis Plane (TAP) block', 'type': 'PROCEDURE', 'description': 'The anterior axillary line is used as landmarks. After insertion of the optic trocar, the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. A solution of 15 ml of Ropivacaine (0.2%) is then injected. The procedure is performed then 2 cm caudal to the first landmark on the same side.\n\nThe procedure is than repeated identically on the contralateral side.', 'armGroupLabels': ['Laparoscopic Transversus Abdominis Plane (L-TAP) group']}, {'name': 'ultrasound-assisted Transversus Abdominis Plane (TAP) block', 'type': 'PROCEDURE', 'description': 'Whilst the patient is in the supine position, a high frequency ultrasound probe is placed transverse to the abdominal wall between the costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. Then 15 ml of local anaesthetic solution is injected. The needle is than retracted until its tip is positioned in the fascial plane between the internal and the external oblique muscles and a second bolus of 15 ml of local anaesthetic is injected. The procedure is than repeated identically on the contralateral side.', 'armGroupLabels': ['Ultrasound Transversus Abdominis Plane (U-TAP) group']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)', 'armGroupLabels': ['Laparoscopic Transversus Abdominis Plane (L-TAP) group', 'Ultrasound Transversus Abdominis Plane (U-TAP) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Davide La Regina, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ente Ospedaliero Cantonale (EOC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Davide La Regina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Davide La Regina', 'investigatorAffiliation': 'Ente Ospedaliero Cantonale, Bellinzona'}}}}