Nctid:
NCT06233318
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M13069", "name"=>"Pain, Postoperative", "relevance"=>"LOW"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077212", "term"=>"Ropivacaine"}], "ancestors"=>[{"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"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"=>"M1700", "name"=>"Ropivacaine", "asFound"=>"Stress", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "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"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"PIFB will be administered to the patient after anesthesia induction and before surgical incision according to the randomization regimen. The unblinded researcher will randomize and inform to the unblinded anesthesia care provider who will perform the PIFB procedure. The rest of clinicians, research personnel and patients will be blinded to the group assignment."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>84}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-10-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2027-01-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-12", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"OPIOID consumption at 24 hours", "timeFrame"=>"24 hours after block procedure", "description"=>"To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups"}, {"measure"=>"OPIOID consumption during surgery", "timeFrame"=>"Surgery length", "description"=>"To compare the amount of opioid consumption oral MME consumption during surgery between groups"}, {"measure"=>"NRS pain score at 48 hours", "timeFrame"=>"Up to 48 hours after block procedure", "description"=>"To compare the NRS (0-10) pain score up to 48 hours"}, {"measure"=>"Worst pain score at 48 hours", "timeFrame"=>"Up to 48 hours after block procedure", "description"=>"To compare the worst pain experienced during up to 48-hours after surgery between groups"}, {"measure"=>"Incidence nausea and/or vomiting after surgery", "timeFrame"=>"Up to 48 hours after block procedure", "description"=>"To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups"}, {"measure"=>"Self-reported satisfaction score at 48 hours", "timeFrame"=>"48 hours after block procedure", "description"=>"To compare self-reported patient satisfaction up to 48 hours after surgery between both groups"}, {"measure"=>"pain-DETECT scores at 90 days", "timeFrame"=>"Up to 90 days after block procedure", "description"=>"To compare the \"pain-DETECT\" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Autonomic Nerve Block"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \\[MMA\\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called \"Pecto-Intercostal Fascial Block \\[PIFB\\]\") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.", "detailedDescription"=>"Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.\n\nStudy participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.\n\nSample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult male or female patients aged \\> 18\n* Undergoing primary cardiac surgery requiring sternotomy\n* Able to provide a signed written informed consent\n* Able to speak, read, and write in English\n* American Society of Anesthesiologists (ASA) physical status I-IV\n\nExclusion Criteria:\n\n* Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception\n* Diabetes Mellitus with documented neuropathic pain\n* Vulnerable populations: pregnant females, prisoners, breast feeding\n* Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone\n* Previous cardiac surgery\n* Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery\n* Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study\n* BMI ≥ 40 kg/m2"}, "identificationModule"=>{"nctId"=>"NCT06233318", "briefTitle"=>"Sternotomy PIFB Block in Open Heart Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Ohio State University"}, "officialTitle"=>"Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: A Randomized, Double-blind, Controlled Trial", "orgStudyIdInfo"=>{"id"=>"2023H0076"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Pecto-intercostal fascial block", "description"=>"Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.", "interventionNames"=>["Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.", "interventionNames"=>["Procedure: Pecto-intercostal Fascial Block with normal saline"]}], "interventions"=>[{"name"=>"Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine", "type"=>"PROCEDURE", "description"=>"The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.", "armGroupLabels"=>["Pecto-intercostal fascial block"]}, {"name"=>"Pecto-intercostal Fascial Block with normal saline", "type"=>"PROCEDURE", "description"=>"The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Alberto A Uribe", "role"=>"CONTACT", "email"=>"alberto.uribe@osumc.edu", "phone"=>"614-293-0775"}, {"name"=>"Jeremy Reeves", "role"=>"CONTACT", "email"=>"jeremy.reeves@osumc.edu", "phone"=>"6142933559"}], "facility"=>"The Ohio State University Wexner Medical Center", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}], "centralContacts"=>[{"name"=>"Alberto A Uribe", "role"=>"CONTACT", "email"=>"alberto.uribe@osumc.edu", "phone"=>"6142930775"}, {"name"=>"Jeremy Reeves", "role"=>"CONTACT", "email"=>"jeremy.reeves@osumc.edu", "phone"=>"6142933559"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"We estimate that a calculated sample size of 42 patients per group: PN ropivacaine and PN saline (control group)is required for a statistical power of 0.90 and a type I error of 0.05, to detect a 15% reduction (65 μg vs 55 μg, SD=13) in MME use between groups, accounting for 90% successful block rate and 10% of loss to follow-up; a total of 84 patients will be included. The primary outcome of mean MME of pain will be compared between the groups using a two-sample t-test or non-parametric equivalent. Continuous secondary outcomes will be analyzed using the same methods. Categorical secondary outcomes will be analyzed using Chi-square test/Fisher's Exact tests."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ohio State University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Erica Stein", "investigatorAffiliation"=>"Ohio State University"}}}}
