Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-04-23 @ 6:01 PM
Study NCT ID:
NCT02927405
Status:
WITHDRAWN
Last Update Posted:
2021-05-25
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Did not get the study to take off, did not recruit any subjects, and then closed the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of nausea and vomiting', 'timeFrame': '24 hours after surgery', 'description': 'How many times the patient reported nausea, and how many times they vomitted.'}], 'primaryOutcomes': [{'measure': 'Post-operative morphine consumption', 'timeFrame': '24 hours after surgery.', 'description': 'Total amount of morphine the patient need to control post-operative pain'}], 'secondaryOutcomes': [{'measure': 'VAS Scores', 'timeFrame': '24 hours after surgery', 'description': "Visual analog scale that rates a patient's pain"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gabapentin', 'TAP block'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'There is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. There are no studies that have compared a TAP block versus a TAP block plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin and receiving a TAP block decrease post-operative morphine consumption. It will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because gabapentin will be used to decrease visceral and central pain, and TAP block will decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* receiving laparoscopic GYN procedure\n* between 18-60\n\nExclusion Criteria:\n\n* are already taking gabapentin\n* have diabetic neuropathy\n* have a chronic pain syndrome\n* take opioids at home\n* are pregnant\n* have kidney disease\n* have an allergy to morphine'}, 'identificationModule': {'nctId': 'NCT02927405', 'briefTitle': 'Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Downstate Medical Center'}, 'officialTitle': 'Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain', 'orgStudyIdInfo': {'id': '926072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'TAP Block plus placebo', 'description': 'Patients will only receive a TAP block procedure and then morphine consumption will be recorded.', 'interventionNames': ['Procedure: TAP Block']}, {'type': 'EXPERIMENTAL', 'label': 'TAP Block plus gabapentin', 'description': 'Patients will receive a TAP block procedure and take pre-operative oral Gabapentin and morphine consumption will me recorded after surgery.', 'interventionNames': ['Drug: Gabapentin', 'Procedure: TAP Block']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': 'anticonvulsant drug that is used for neuropathic pain.', 'armGroupLabels': ['TAP Block plus gabapentin']}, {'name': 'TAP Block', 'type': 'PROCEDURE', 'description': 'a procedure done anesthetize the anterior abdominal wall', 'armGroupLabels': ['TAP Block plus gabapentin', 'TAP Block plus placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Downstate Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Pain Medicine', 'investigatorFullName': 'Shantha Ganesan', 'investigatorAffiliation': 'State University of New York - Downstate Medical Center'}}}}