Nctid:
NCT06614257
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000059787", "term"=>"Acute Pain"}], "ancestors"=>[{"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M13069", "name"=>"Pain, Postoperative", "relevance"=>"LOW"}, {"id"=>"M29525", "name"=>"Acute Pain", "asFound"=>"Acute Pain", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000000779", "term"=>"Anesthetics, Local"}], "ancestors"=>[{"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "asFound"=>"Provider", "relevance"=>"HIGH"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "asFound"=>"Youth", "relevance"=>"HIGH"}, {"id"=>"M1700", "name"=>"Ropivacaine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}]}}, "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"=>84}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-01-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-03-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-05-16", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-03", "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"=>"Ketorolac 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"=>"Length of Hospital Stay", "timeFrame"=>"72 hours", "description"=>"Time between surgery and dismission from the hospital"}, {"measure"=>"Timt 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 Complications", "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"=>"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."}, {"pmid"=>"29980989", "type"=>"RESULT", "citation"=>"Ruiz-Tovar J, Garcia A, Ferrigni C, Gonzalez J, Levano-Linares C, Jimenez-Fuertes M, Llavero C, Duran M. Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block as Part of Multimodal Analgesia in Laparoscopic Roux-en-Y Gastric Bypass Within an Enhanced Recovery After Surgery (ERAS) Program: a Prospective Randomized Clinical Trial. Obes Surg. 2018 Nov;28(11):3374-3379. doi: 10.1007/s11695-018-3376-8."}]}, "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 gastric bypass. 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 Gastric Bypass\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"=>"NCT06614257", "acronym"=>"REPABS-BPG", "briefTitle"=>"REduced Pain After Bariatric Surgery - Gastric Bypass", "organization"=>{"class"=>"OTHER", "fullName"=>"Fondazione Policlinico Universitario Campus Bio-Medico"}, "officialTitle"=>"REduced Pain After Bariatric Surgery - Gastric Bypass (REPABS-BPG)", "orgStudyIdInfo"=>{"id"=>"PAR 90/21"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"LG-TAP", "description"=>"The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Local Anesthetic (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"=>["Drug: LG-TAP block with local anesthetic", "Procedure: Port site infiltration"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"PLACEBO", "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: Port site infiltration", "Drug: LG-TAP block with saline solution"]}], "interventions"=>[{"name"=>"LG-TAP block with local anesthetic", "type"=>"DRUG", "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"=>"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", "PLACEBO"]}, {"name"=>"LG-TAP block with saline solution", "type"=>"DRUG", "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"=>["PLACEBO"]}]}, "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 Campus Bio-Medico"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fondazione Policlinico Universitario Campus Bio-Medico", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Vincenzo Bruni", "investigatorAffiliation"=>"Fondazione Policlinico Universitario Campus Bio-Medico"}}}}
