{
  "FullStudy":{
    "Rank":218086,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512914",
          "OrgStudyIdInfo":{
            "OrgStudyId":"AR HSG 01-2008"
          },
          "Organization":{
            "OrgFullName":"San Gerardo Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery",
          "OfficialTitle":"Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2009",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2009",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 15, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 18, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Pablo Mauricio Ingelmo M.D.",
            "ResponsiblePartyInvestigatorTitle":"MD",
            "ResponsiblePartyInvestigatorAffiliation":"San Gerardo Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"San Gerardo Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after gynecologic laparoscopic surgery.",
          "DetailedDescription":"Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic surgery have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. The investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief than ropivacaine instillation after gynecologic laparoscopic surgery. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization before or after surgery compared with intraperitoneal ropivacaine instillation and placebo after gynecologic laparoscopic procedures."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Gynecologic Laparoscopic Surgery"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Gynecologic laparoscopic surgery",
              "Postoperative pain",
              "Nebulization",
              "Ropivacaine"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"120",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"CONTROL group",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: saline"
                  ]
                }
              },{
                "ArmGroupLabel":"PREOPERATIVE nebulization",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ropivacaine 30 mg"
                  ]
                }
              },{
                "ArmGroupLabel":"POSTOPERATIVE nebulization",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ropivacaine 30 mg"
                  ]
                }
              },{
                "ArmGroupLabel":"INSTILLATION group",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ropivacaine 100 mg"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Ropivacaine 30 mg",
                "InterventionDescription":"preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PREOPERATIVE nebulization"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Ropivacaine 30 mg",
                "InterventionDescription":"preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "POSTOPERATIVE nebulization"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Ropivacaine 100 mg",
                "InterventionDescription":"preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "INSTILLATION group"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"saline",
                "InterventionDescription":"preoperative instillation of saline 20 ml and nebulization of saline before and after surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "CONTROL group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"postoperative pain",
                "PrimaryOutcomeDescription":"Postoperative pain was assessed by NRS (0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.",
                "PrimaryOutcomeTimeFrame":"24 hours"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"morphine consumption",
                "SecondaryOutcomeDescription":"The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display",
                "SecondaryOutcomeTimeFrame":"24 hours"
              },{
                "SecondaryOutcomeMeasure":"Unassisted walking time",
                "SecondaryOutcomeDescription":"Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance.",
                "SecondaryOutcomeTimeFrame":"24 hours"
              },{
                "SecondaryOutcomeMeasure":"Hospital stay",
                "SecondaryOutcomeDescription":"We define hospital stay as the elapsed time between surgery and hospital discharge",
                "SecondaryOutcomeTimeFrame":"between surgery and discharge"
              },{
                "SecondaryOutcomeMeasure":"hospital morbidity",
                "SecondaryOutcomeDescription":"All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified using the anesthesia charts, surgical charts, surgical database.",
                "SecondaryOutcomeTimeFrame":"up to discharge"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFemales 18-70 years old, ASA score 1 - 3;\nscheduled for laparoscopic operative surgery in the Obstetrics and Gynecology unit;\nfree from pain in preoperative period, without habitual analgesic use;\nwithout cognitive impairment or mental retardation, who gave a written informed consent\n\nExclusion Criteria:\n\nFemales under 18 or over 70;\nASA 4 or 5;\nemergency/urgency criteria, postoperative admission in a intensive care unit with sedation or ventilatory assistance; cognitive impairment or mental retardation;\nhabitual analgesic use; progressive degenerative diseases of the CNS;\nconvulsions or chronic therapy with antiepileptic drugs;\nsevere hepatic or renal impairment;\npregnancy or lactation;\nallergy to one of the specific substances used in the study;\nacute infectious disease or inflammatory chronic disease, alcohol or drug addiction;\nany kind of communication problem;\nneurologic or psychiatric disease;\nno written informed consent",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Pablo M Ingelmo, MD",
                "OverallOfficialAffiliation":"San Gerardo Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"San Gerardo Hospital",
                "LocationCity":"Monza",
                "LocationState":"MB",
                "LocationZip":"20052",
                "LocationCountry":"Italy"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"10910857",
                "ReferenceType":"result",
                "ReferenceCitation":"Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7."
              },{
                "ReferencePMID":"17180268",
                "ReferenceType":"result",
                "ReferenceCitation":"Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. Epub 2006 Dec 16."
              },{
                "ReferencePMID":"18633034",
                "ReferenceType":"result",
                "ReferenceCitation":"Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000077212",
                "InterventionMeshTerm":"Ropivacaine"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000779",
                "InterventionAncestorTerm":"Anesthetics, Local"
              },{
                "InterventionAncestorId":"D000000777",
                "InterventionAncestorTerm":"Anesthetics"
              },{
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000018689",
                "InterventionAncestorTerm":"Sensory System Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1700",
                "InterventionBrowseLeafName":"Ropivacaine",
                "InterventionBrowseLeafAsFound":"Ropivacaine",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2688",
                "InterventionBrowseLeafName":"Anesthetics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2690",
                "InterventionBrowseLeafName":"Anesthetics, Local",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"CNSDep",
                "InterventionBrowseBranchName":"Central Nervous System Depressants"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000010149",
                "ConditionMeshTerm":"Pain, Postoperative"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000011183",
                "ConditionAncestorTerm":"Postoperative Complications"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000010146",
                "ConditionAncestorTerm":"Pain"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11652",
                "ConditionBrowseLeafName":"Pain, Postoperative",
                "ConditionBrowseLeafAsFound":"Postoperative Pain",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12648",
                "ConditionBrowseLeafName":"Postoperative Complications",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}