Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-03-21 @ 3:10 PM
Study NCT ID:
NCT01550094
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2012-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2012-03-07', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obese', 'regional anesthesia', 'anesthesia', 'anesthesiology', 'surgery', 'foot', 'foot surgery', 'ankle', 'ankle surgery', 'orthopedics', 'orthopedic surgery', 'sports medicine', 'sports medicine surgery', 'Ochsner Hospital', 'Ochsner Clinic', 'New Orleans', 'Louisiana', 'Jefferson', 'Soberon'], 'conditions': ['Strain of Muscle and/or Tendon of Lower Leg', 'Fracture of Lower Leg', 'Crushing Injury of Lower Leg', 'Fracture Malunion - Ankle and/ or Foot', 'Complete Tear, Ankle and/or Foot Ligament', 'Pathological Fracture - Ankle and/or Foot', 'Loose Body in Joint of Ankle and/or Foot']}, 'descriptionModule': {'briefSummary': 'One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. By injecting numbing medication around the nerve(s), there will be less pain after the procedure. It is thought that the numbing medicine will be easier to inject in the group that the nerves are split. It is expected that subjects may need less pain medication and have lower pain ratings in this group too.', 'detailedDescription': 'The purpose of this study is to compare two different techniques for placement of nerve blocks for your foot or ankle procedure. A nerve block involves injecting numbing medications around a nerve to decrease pain after surgery. An ultrasound machine is often used to help see the nerve before injecting the numbing medicine. When an ultrasound machine is used during a block it is called an ultrasound-guided block.\n\nMany studies of ultrasound-guided nerve blocks have involved mostly thin patients, especially from foreign countries. This study is different because the investigators are looking at patients living in America with a body mass index (a measure of the amount of body fat a person has) of more than 35.\n\nThe Sciatic nerve is a large nerve that provides most of the feeling and all of the movement to the foot and ankle. The nerve travels under the back of the leg, and splits into two smaller nerves slightly above the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severely and morbidly obese patients scheduled for foot or ankle surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery\n* Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively\n* ASA status I-IV\n* Ability to understand and provide informed consent\n\nExclusion Criteria:\n\n* True allergy, not sensitivity, to any of the following substances:\n\nLocal Anesthetics Midazolam Fentanyl Hydromorphone Propofol\n\n* Pregnancy\n* Evidence of infection at or near the proposed needle insertion site\n* Unstable or undetermined neurologic disease of the lower extremity\n* Chronic pain patients\n* Patient refusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01550094', 'briefTitle': 'A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations', 'orgStudyIdInfo': {'id': '2011.191.B'}, 'secondaryIdInfos': [{'id': '2011.191.B', 'type': 'OTHER', 'domain': 'Ochnser Clinic Foundation Institutional Review Board'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Jose Soberon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Soberon, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Jose Soberon, MD', 'investigatorAffiliation': 'Ochsner Health System'}}}}