Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 2:28 AM
Study NCT ID:
NCT06447194
Status:
WITHDRAWN
Last Update Posted:
2025-07-31
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of RECK in Posterior Spinal Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded by investigational drug service'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was not feasible due to logistical and implementation challenges. No participants were enrolled and the study will not proceed further.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative VAS Pain Scores', 'timeFrame': '2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)', 'description': 'Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.\n\nVAS (Visual Analogue Scale) measures pain intensity. The VAS is a 10cm line with two end points representing 0 ("No pain") and 10 ("Pain as bad as it could be"). The patient is asked to rate their pain by placing a marker on the line. A lower score (thus closer to "no pain") is a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Opioid Utilization', 'timeFrame': 'Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)', 'description': 'Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Up to 2 weeks (an average of 4 days)', 'description': 'Secondary aims: to investigate of effect of RECK injection on hospital length of stay.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spine Surgery', 'Lumbar Fusion', 'Pain Control', 'Opioid Utilization', 'Local Anesthesia', 'RECK', 'R.E.C.K.', 'Ropivacaine', 'Epinephrine', 'Clonidine', 'Ketorolac', 'Randomized Controlled Trial'], 'conditions': ['Degenerative Lumbar Spinal Stenosis', 'Degenerative Disc Disease', 'Degenerative Spondylolisthesis', 'Degenerative Disease']}, 'descriptionModule': {'briefSummary': '"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following.\n\nPrimary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.\n\nSecondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay.\n\nHypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.', 'detailedDescription': 'Patients will be randomized into two groups. Intraoperatively, they will be given either 1) a 50 mL RECK (ropivacaine, epinephrine, clonidine, and ketorolac) cocktail containing 123 mg ropivacaine, 0.25 mg epinephrine, 0.04 mg clonidine, and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed (intervention group), or 2) a 50 mL injection of saline (control group). RECK is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons. All patients will have a patient-controlled analgesia pump initiated shortly after surgery, with routine postoperative care and observation from nurses, pain management, and orthopedic surgeons and residents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-88 years old\n* Undergoing spinal fusion at 1-3 lumbar levels via a posterior approach.\n\nExclusion Criteria:\n\n* Revision surgeries\n* Surgeries indicated for trauma, tumor, or infection\n* Preoperative history of moderate to severe hepatic, renal, cardiac, or psychiatric illness\n* Known hypersensitivity to any of the RECK components'}, 'identificationModule': {'nctId': 'NCT06447194', 'briefTitle': 'Effect of RECK in Posterior Spinal Fusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion', 'orgStudyIdInfo': {'id': 'HP-00109268'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (RECK)', 'description': 'The arm of patients who will be administered "RECK" local anesthesia cocktail:\n\nRopivacaine 0.125g Clonidine 80 mcg Epinephrine 0.5 mg Ketorolac 30 mg In sterile water 73 mL (total volume of compound is 100 mL)\n\nGiven through paraspinal muscle injection once intraoperatively.', 'interventionNames': ['Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group (Placebo)', 'description': 'The arm of patients who will be administered a placebo injection:\n\n100 mL Normal Saline\n\nGiven through paraspinal muscle injection once intraoperatively.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail', 'type': 'DRUG', 'otherNames': ['RECK'], 'description': 'Please refer to description for interventional group.', 'armGroupLabels': ['Intervention (RECK)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '100mL paraspinal normal saline injection intraoperatively, once.', 'armGroupLabels': ['Control Group (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Orthopaedics', 'investigatorFullName': 'Steven Ludwig', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}