Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-18 @ 2:48 AM
Study NCT ID:
NCT03247257
Status:
UNKNOWN
Last Update Posted:
2017-08-11
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000767', 'term': 'Anesthesia, Epidural'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Anesthesia Recovery Score for Ambulatory Patients', 'timeFrame': 'Immediately postoperative', 'description': 'PARSAP scores in the post-anesthesia recovery unit'}], 'secondaryOutcomes': [{'measure': 'SF-12 Health survey scores', 'timeFrame': 'Postoperative days 1, 6, 7/8/9 or 10, 30, 90', 'description': 'scale of 12-47'}, {'measure': 'Pain', 'timeFrame': 'Immediately postoperative through postoperative day 90', 'description': 'VAS 0-10 scale'}, {'measure': 'Opioid requirement', 'timeFrame': 'Preoperative through postoperative day 90', 'description': 'Opioid use in milligrams through postoperative day 90 will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholelithiasis']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder removal. The objective of this study is to compare Epidural versus General Anesthesia for postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy patients.', 'detailedDescription': 'This is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adult patients that require an elective cholecystectomy.\n\nPatients will be randomized 1:1 to receive either general anesthesia (Group A) or epidural anesthesia (Group B) for their laparoendoscopic single site incision (LESS) gallbladder removal surgery (cholecystectomy). Randomization will be achieved using a computer-generated list. The patient will know what are they are randomized to before entering the operating room because an epidural will need to be placed preoperatively. Standards for basic anesthetic monitoring approved by the American Society of Anesthesiologists will occur intraoperatively.\n\nPostoperative evaluations will be completed by a medical professional that is blinded to the type of anesthesia used during the LESS surgery. Postoperative evaluations include a physical exam, adverse events, medication administration, vital signs and post-anesthesia recovery score for ambulatory patients (PARSAP) scores will be taken every 15 minutes until the patient has a score of at least 18.\n\nPatients will be followed 90 days postoperatively to collect pain scores, analgesic use, adverse events, and quality of life questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 65 years of age\n* ASA I or II\n* Patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic gallstones, polyps by imaging or biliary dyskinesia with documented EF \\< 30%\n* No cardiopulmonary disease\n* Normal coagulation profile\n\nExclusion Criteria:\n\n* Any female patient, who is pregnant, suspected pregnant, or nursing\n* Contraindication for pneumoperitoneum\n* Contraindication for epidural anesthesia\n* Allergy to local anesthetic agents\n* Any patient with acute calculus or acalculous cholecystitis\n* Any patient who has had an upper midline or right sub costal incision\n* Any patient with preoperative indication for a cholangiogram\n* Any patient with ASA ≥ 3\n* Any patient who is undergoing Peritoneal Dialysis (PD)\n* History of long term analgesic use requiring pain management (\\>1 week)\n* Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair\n* Any patient with obstructive sleep apnea (OSA), history of OSA or at high risk of OSA as determined by the STOP Questionnaire\n* BMI \\> 35 kg/m2\n* Any patient with a history of severe, uncontrolled GERD'}, 'identificationModule': {'nctId': 'NCT03247257', 'briefTitle': 'Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies', 'organization': {'class': 'OTHER', 'fullName': 'Florida Hospital Tampa Bay Division'}, 'officialTitle': 'Epidural Versus General Anesthesia for Laparoendoscopic Single Site Cholecystectomy: A Prospective, Comparative, Controlled, Blinded Study', 'orgStudyIdInfo': {'id': '482717 revised'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: General Anesthesia', 'description': '35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.', 'interventionNames': ['Procedure: General Anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Epidural Anesthesia', 'description': '35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.', 'interventionNames': ['Procedure: Epidural Anesthesia']}], 'interventions': [{'name': 'General Anesthesia', 'type': 'PROCEDURE', 'otherNames': ['IV propofol'], 'description': 'Patients will be put under general anesthesia for cholecystectomy', 'armGroupLabels': ['Group A: General Anesthesia']}, {'name': 'Epidural Anesthesia', 'type': 'PROCEDURE', 'otherNames': ['Epidural lidocaine'], 'description': 'Patients will receive Epidural Anesthesia for cholecystectomy', 'armGroupLabels': ['Group B: Epidural Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Sharona Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Hospital Tampa'}, {'name': 'Alexander Rosemurgy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Hospital Tampa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Hospital Tampa Bay Division', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Surgical Digestive Disorders and GERD Center', 'investigatorFullName': 'Alexander Rosemurgy', 'investigatorAffiliation': 'Florida Hospital Tampa Bay Division'}}}}