Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-02 @ 1:20 AM
Study NCT ID:
NCT00372268
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2006-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007035', 'term': 'Hypothermia'}], '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': 'D001832', 'term': 'Body Temperature Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2006-09-05', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of core temperature', 'timeFrame': 'From the beginning of the anesthetic procedure to the discharge of the recovery room.'}, {'measure': 'Post-operative pain', 'timeFrame': 'From the arrival in the recovery room to the 6th post-operative day.'}], 'secondaryOutcomes': [{'measure': 'Inflammation parameters', 'timeFrame': 'From the beginning of the anesthetic procedure to the end of the surgical procedure (one blood sample is done before the surgery, the second is done just after the arrival in the recovery room)'}, {'measure': 'Quality of life', 'timeFrame': 'From the discharge of the recovery room to the 6th post-operative day'}, {'measure': 'Surgical comfort', 'timeFrame': 'During the duration of the surgical procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Comparison of four conditionings of the insufflated gas during laparoscopy and their consequences on the core temperature and the post-operative pain.', 'Women with womb pathology needing laparoscopic surgery', 'No emergency', 'Aged over 18 years'], 'conditions': ['Laparoscopy', 'Pain, Postoperative', 'Hypothermia']}, 'referencesModule': {'references': [{'pmid': '18633034', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.\n\nThe investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:\n\n* CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl\n* CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl\n* CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%\n* CO2 dry and cold with direct intra-abdominal administration of Nacl\n\nThe investigators use a new device (Aeroneb® Pro \\[Aerogen® Company\\]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Womb surgery by laparoscopy\n* Female\n* Aged over 18 years\n* No emergency\n\nExclusion Criteria:\n\n* Laparotomy\n* Protocol rejected by the patient\n* Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas'}, 'identificationModule': {'nctId': 'NCT00372268', 'briefTitle': 'Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery', 'orgStudyIdInfo': {'id': '3621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery', 'interventionNames': ['Device: Aeroneb® Pro (Nektar® Company)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': 'Administration of ropivacaïne 0,75% by nebulization in the insufflated gas during all the surgical procedure with direct intra-abdominal administration of Nacl 0,9%', 'interventionNames': ['Device: Aeroneb® Pro (Nektar® Company)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'Administration of Nacl 0,9% by nebulization in the insufflated gas during all the surgical procedure with direct intra-abdominal administration of Nacl 0,9%', 'interventionNames': ['Device: Aeroneb® Pro (Nektar® Company)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'description': 'Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery', 'interventionNames': ['Device: Aeroneb® Pro (Nektar® Company)']}], 'interventions': [{'name': 'Aeroneb® Pro (Nektar® Company)', 'type': 'DEVICE', 'description': 'The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.', 'armGroupLabels': ['A', 'C']}, {'name': 'Aeroneb® Pro (Nektar® Company)', 'type': 'DEVICE', 'description': 'The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.', 'armGroupLabels': ['B', 'D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67300', 'city': 'Schiltigheim', 'country': 'France', 'facility': 'Sihcus-Cmco', 'geoPoint': {'lat': 48.60749, 'lon': 7.74931}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '20051', 'city': 'Monza', 'country': 'Italy', 'facility': 'Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'overallOfficials': [{'name': 'Pierre DIEMUNSCH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}