Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-17 @ 3:40 AM
Study NCT ID:
NCT01743794
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2012-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Wound Infusion in Lumbar or Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2012-05-09', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'number of patients in need of morphine in post surgery monitoring room', 'timeFrame': '1 hour after surgery'}, {'measure': 'morphine consumption in post surgery monitoring room', 'timeFrame': '1 hour post surgery'}, {'measure': 'consumption of morphine', 'timeFrame': '72 hours after surgery'}, {'measure': 'global self appreciation of pain management', 'timeFrame': 'at 72 hours'}, {'measure': 'Time required for post surgery functional recovery', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}, {'measure': 'Adverse effects of morphine', 'timeFrame': '72 hours after surgery'}, {'measure': 'hospitalization delay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}, {'measure': 'asked bolus divided by delivered bolus', 'timeFrame': 'until 72 hours after surgery'}, {'measure': 'Score for pain intensity', 'timeFrame': 'until 72 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lumbar Spine Surgery', 'Thoracic Spine Surgery']}, 'referencesModule': {'references': [{'pmid': '26865083', 'type': 'DERIVED', 'citation': 'Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.\n\nMethods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* \\> 18 years\n* Physical status score I, II or III (American Society of Anesthesiologists)\n* lumbar or thoracic spine surgery with arthrodesis through posterior only approach\n* signed informed consent\n* beneficiary of social security\n\nExclusion Criteria:\n\n* vulnerable persons according to law\n* scoliosis surgery\n* local anesthetic allergia\n* contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol\n* long term anti platelet aggregants\n* inability to comply to protocol requirements\n* psychiatric disorders or cognitive disabilities\n* chronic pain or long term opioids consumption\n* diabetes\n* obesity (BMI \\> 30)\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01743794', 'briefTitle': 'Continuous Wound Infusion in Lumbar or Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study', 'orgStudyIdInfo': {'id': '1008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ropivacaine 0.2%, wound infusion', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline solution 0.9%, wound infusion', 'interventionNames': ['Drug: Saline solution 0.9%']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion', 'armGroupLabels': ['ropivacaine 0.2%, wound infusion']}, {'name': 'Saline solution 0.9%', 'type': 'DRUG', 'description': 'wound infusion, 0.9%, bolus 10mL followed by 8 mL/h', 'armGroupLabels': ['saline solution 0.9%, wound infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'University Hospital, Departement of Anesthesia and Intensive Care', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}