Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-07 @ 12:01 AM
Study NCT ID:
NCT06383234
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REduced Pain After Bariatric Surgery - Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-21', 'studyFirstSubmitDate': '2024-04-21', 'studyFirstSubmitQcDate': '2024-04-21', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': '24 hours', 'description': 'A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Morphine Consumption', 'timeFrame': '24 hours', 'description': 'Total of intravenous morphine (expressed in milligrams) administered administered during the first 24 hours after surgery'}, {'measure': 'Toradol Consumption', 'timeFrame': '24 hours', 'description': 'Total of intravenous toradol (expressed in milligrams) administered administered during the first 24 hours after surgery'}, {'measure': 'Nausea and/or vomiting', 'timeFrame': '48 hours', 'description': 'Incidence of nausea and/or vomiting'}, {'measure': 'Lenght of Hospital Stay', 'timeFrame': '72 hours', 'description': 'Time between surgery and dismission from the hospital'}, {'measure': 'Time to walking', 'timeFrame': '72 hours', 'description': 'Time between surgery and patient starting to walk'}, {'measure': 'Time to first flatus', 'timeFrame': '72 hours', 'description': 'Time between surgery and patient having flatus'}, {'measure': 'Surgical Complication', 'timeFrame': '7 days', 'description': 'Incidence of complications related to surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Postoperative Pain', 'Acute Pain', 'Analgesia', 'Bariatric Surgery Candidate', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '37740830', 'type': 'BACKGROUND', 'citation': 'Mongelli F, Marengo M, Bertoni MV, Volonte F, Ledingham NS, Garofalo F. Laparoscopic-Assisted Transversus Abdominis Plane (TAP) Block Versus Port-Site Infiltration with Local Anesthetics in Bariatric Surgery: a Double-Blind Randomized Controlled Trial. Obes Surg. 2023 Nov;33(11):3383-3390. doi: 10.1007/s11695-023-06825-7. Epub 2023 Sep 23.'}, {'pmid': '35143011', 'type': 'RESULT', 'citation': 'Ripolles-Melchor J, Sanchez-Santos R, Abad-Motos A, Gimeno-Moro AM, Diez-Remesal Y, Jove-Albores P, Arago-Chofre P, Ortiz-Sebastian S, Sanchez-Martin R, Ramirez-Rodriguez JM, Trullenque-Juan R, Valenti-Azcarate V, Ramiro-Ruiz A, Correa-Chacon OC, Batalla A, Gimeno-Grauwinkel C, Sanahuja-Blasco JM, Gonzalez-Valverde FM, Galan-Menendez P, Diez-Zapirain MJ, Vilallonga R, Zorrilla-Vaca A, Pascual-Bellosta AM, Martinez-Ubieto J, Carrascosa-Miron T, Ruiz-Escobar A, Martin-Garcia-Almenta E, Suarez-de-la-Rica A, Bausili M, Palacios-Cordoba A, Olvera-Garcia MM, Meza-Vega JA, Sanchez-Pernaute A, Abad-Gurumeta A, Ferrando-Ortola C, Martin-Vaquerizo B, Torres-Alfonso JR, Aguado-Sanchez S, Sanchez-Cabezudo-Noguera F, Garcia-Erce JA, Aldecoa C; POWER 3 Study Investigators Group. Higher Adherence to ERAS Society(R) Recommendations is Associated with Shorter Hospital Stay Without an Increase in Postoperative Complications or Readmissions in Bariatric Surgery: the Association Between Use of Enhanced Recovery After Surgery Protocols and Postoperative Complications after Bariatric Surgery (POWER 3) Multicenter Observational Study. Obes Surg. 2022 Apr;32(4):1289-1299. doi: 10.1007/s11695-022-05949-6. Epub 2022 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Elective Laparoscopic Sleeve Gastrectomy\n* Body Mass Index (BMI) \\> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)\n* BMI \\> 40 kg/m², even in the absence of comorbidities\n* ASA physical status score \\< 4\n\nExclusion Criteria:\n\n* ASA physical status score ≥ 4\n* Patient's refusal or inability to sign the informed consent\n* Allergies to any drug provided by the study protocol"}, 'identificationModule': {'nctId': 'NCT06383234', 'acronym': 'REPABS-SG', 'briefTitle': 'REduced Pain After Bariatric Surgery - Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Campus Bio-Medico'}, 'officialTitle': 'REduced Pain After Bariatric Surgery - Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'PAR 89/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LG-TAP', 'description': 'The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Ropivacaine Hydrochloride 0.5% on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.', 'interventionNames': ['Procedure: LG-TAP block with local anesthetic', 'Procedure: Port site infiltration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SALINE', 'description': 'The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.', 'interventionNames': ['Procedure: LG-TAP block with saline solution', 'Procedure: Port site infiltration']}], 'interventions': [{'name': 'LG-TAP block with local anesthetic', 'type': 'PROCEDURE', 'description': 'The laparoscopic guided TAP Block was performed by surgeon at the beginning of surgery, injecting 15 ml of Ropivacaine 0.5% on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.', 'armGroupLabels': ['LG-TAP']}, {'name': 'LG-TAP block with saline solution', 'type': 'PROCEDURE', 'description': 'The laparoscopic guided TAP Block was performed by surgeon at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.', 'armGroupLabels': ['SALINE']}, {'name': 'Port site infiltration', 'type': 'PROCEDURE', 'description': 'Prior the surgical incision, an infiltration of the laparoscopic access using a total of 10 ml Ropivacaine 0.5% was performed by surgeon', 'armGroupLabels': ['LG-TAP', 'SALINE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00128', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Campus Bio-medico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Vincenzo Bruni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Campus Bio-Medico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Campus Bio-Medico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invesigator', 'investigatorFullName': 'Vincenzo Bruni', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Campus Bio-Medico'}}}}