Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 4:27 AM
Study NCT ID:
NCT02444260
Status:
UNKNOWN
Last Update Posted:
2015-05-14
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000083', 'term': 'Acetanilides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale', 'timeFrame': '1 year', 'description': 'Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': '2 weeks'}, {'measure': 'Frequency (total count) of postoperative complications using a questionaire', 'timeFrame': '1 year'}, {'measure': 'Post-operative assessment of physical activity using Activities Assessment Scale', 'timeFrame': '1 year'}, {'measure': 'Time to discharge', 'timeFrame': '2 weeks'}, {'measure': 'change in postoperative pain score from baseline assessed with visual analog scale', 'timeFrame': '1 year', 'description': 'change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inguinal Hernia,', 'Local Anesthesia', 'Randomized Clinical trial', 'HERNIOPLASTY'], 'conditions': ['Inguinal Hernia', 'Anesthesia, Local', 'Conscious Sedation']}, 'referencesModule': {'references': [{'pmid': '28174148', 'type': 'DERIVED', 'citation': 'Leake PA, Toppin PJ, Reid M, Plummer JM, Roberts PO, Harding-Goldson H, McFarlane ME. Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Feb 7;6(2):e20. doi: 10.2196/resprot.6754.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local Anaesthesia alone versus Local Anaesthesia and Conscious Sedation\n\nSpecific study objectives are to determine the effect of conscious sedation on:\n\n(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reducible inguinal hernia\n\nExclusion Criteria:\n\n* Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease\n* Body mass index \\< 18.5 kg/m2 or \\> 30 kg/m2\n* Recurrent inguinal hernias\n* Bilateral inguinal hernias\n* Large inguinoscrotal hernias\n* Incarcerated hernia\n* Allergies to local anaesthetic and sedative agents\n* Pregnancy\n* Lactation\n* Chronic pain syndromes\n* Anxiety disorders\n* Marijuana use\n* Long term use of opioid or sedative agents'}, 'identificationModule': {'nctId': 'NCT02444260', 'briefTitle': 'A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty', 'organization': {'class': 'OTHER', 'fullName': 'The University of The West Indies'}, 'officialTitle': 'Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation', 'orgStudyIdInfo': {'id': 'ECP342,12/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Intravenous Normal Saline', 'description': 'Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i', 'interventionNames': ['Drug: Intravenous Normal Saline', 'Drug: Bupivocaine', 'Drug: Lignocaine HCl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg.', 'interventionNames': ['Drug: Midazolam', 'Drug: Bupivocaine', 'Drug: Lignocaine HCl']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormicum'], 'description': 'Midazolam will administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg. Additional sedation will be given to achieve and maintain a score of 2-3 on the Ramsay sedation scale during the procedure, up to the maximum dose of 10mg.', 'armGroupLabels': ['Midazolam']}, {'name': 'Intravenous Normal Saline', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride solution'], 'description': 'Intravenous normal saline will be infused by non-blinded anaesthetist', 'armGroupLabels': ['Intravenous Normal Saline']}, {'name': 'Bupivocaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg', 'armGroupLabels': ['Intravenous Normal Saline', 'Midazolam']}, {'name': 'Lignocaine HCl', 'type': 'DRUG', 'otherNames': ['xylocaine'], 'description': 'Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg', 'armGroupLabels': ['Intravenous Normal Saline', 'Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kingston', 'state': 'Please Select', 'status': 'RECRUITING', 'country': 'Jamaica', 'contacts': [{'name': 'Pierre Leake, DM', 'role': 'CONTACT', 'email': 'Pierre-Anthony Leake <paeleake@yahoo.com>'}], 'facility': 'University of the West Indies, mona', 'geoPoint': {'lat': 17.99702, 'lon': -76.79358}}], 'centralContacts': [{'name': 'Pierre Leake, DM', 'role': 'CONTACT', 'email': 'Pierre-Anthony Leake <paeleake@yahoo.com>'}, {'name': 'Marvin Reid, PhD', 'role': 'CONTACT', 'email': 'marvin.reid@uwimona.edu.jm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of The West Indies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}