Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-31 @ 4:23 AM
Study NCT ID:
NCT00508066
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2007-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2013-01-15', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2007-07-25', 'dispFirstSubmitQcDate': '2013-01-15', 'studyFirstSubmitQcDate': '2007-07-25', 'dispFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain score', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Physical Therapy Progress', 'timeFrame': 'Post-op day 1, 2, 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congenital Scoliosis', 'Idiopathic Scoliosis', 'Spinal Fusion', 'Post-Operative Pain Management', 'Infusion Catheter'], 'conditions': ['Scoliosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of continuous local anesthetic delivery on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital or idiopathic scoliosis.', 'detailedDescription': 'Constant local analgesic infusion is a relatively new modality that provides a constant supply of medication without the need for repeat injections. This method has shown encouraging results with respect to pain levels, narcotic use, faster rehabilitation and shorter hospital stay in patients undergoing laparotomies, iliac crest bone graft harvest, and sternotomies. In addition, there have not been any reported complications when used in these scenarios.\n\nWe hope to confirm better pain control, less narcotic use (i.e. PCA), fewer narcotic side effects, better response to physical therapy and earlier discharge. Which may be generalized to the spinal surgery patient population as less pain and suffering and a better overall hospital course'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Diagnosis of Congenital Scoliosis\n* Clinical Diagnosis of Idiopathic Scoliosis\n* Anticipated Spinal Fusion Surgery\n\nExclusion Criteria:\n\n* Less than 8 years of age'}, 'identificationModule': {'nctId': 'NCT00508066', 'briefTitle': 'Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shriners Hospitals for Children'}, 'officialTitle': 'Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery', 'orgStudyIdInfo': {'id': 'SHCLA-0116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': "Subjects in arm 1 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse 0.25 - 0.5% (according to patient's weight) Bupivacaine at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management.", 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'Subjects in arm 2 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse normal saline at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours', 'armGroupLabels': ['Arm 1']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline, 4ml/hour for 72 hours.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90020', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Shriners Hospitals for Children - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Norman Otsuka, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shriners Hospitals for Children - Los Angeles'}, {'name': 'Anthony Scaduto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shriners Hospitals for Children - Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Data Coordinator', 'investigatorFullName': 'Terri Green', 'investigatorAffiliation': 'Shriners Hospitals for Children'}}}}