Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
Study NCT ID:
NCT02949661
Status:
WITHDRAWN
Last Update Posted:
2020-09-11
First Post:
2016-10-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Wound Infiltration for Tracheal Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Loss of interest in the subject', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain score', 'timeFrame': 'For 24 hours after surgery', 'description': 'Postoperative pain scores will be assessed using postoperative visual analogue score'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': 'For 4 hours after start of surgery'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'For 4 hours after start of surgery'}, {'measure': 'Heart rate', 'timeFrame': 'For 4 hours after start of surgery'}, {'measure': 'Peripheral oxygen saturation', 'timeFrame': 'For 4 hours after start of surgery'}, {'measure': 'End-tidal Carbon dioxide tension', 'timeFrame': 'For 4 hours after start of surgery'}, {'measure': 'Bispectral index', 'timeFrame': 'For 4 hours after start of surgery'}, {'measure': 'Duration of analgesia', 'timeFrame': 'For 24 hours after surgery', 'description': 'It is defined as time taken for first analgesic request of analgesia from extubation'}, {'measure': 'Cumulative analgesic consumption', 'timeFrame': 'For 24 hours after surgery', 'description': 'total analgesics used for 24 hrs after surgery'}, {'measure': 'Cortisol serum', 'timeFrame': 'before induction ,one hour after start of surgery and one hour after end of surgery', 'description': 'Plasma cortisol assay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Upper Tracheal Resection', 'Tracheal Reconstruction Surgery']}, 'descriptionModule': {'briefSummary': 'Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The postintubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.\n\nBilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics\n\nLocal anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach.\n\nLevobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.', 'detailedDescription': 'The aim of this study is to evaluate the intra- and postoperative efficacy of local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical class status I or II\n* Undergoing elective upper tracheal resection and reconstruction surgery\n\nExclusion Criteria:\n\n* Age less than18 years\n* Patients with preoperative medication included opioid\n* History of allergy to the drugs used\n* Coagulation disorders\n* Pregnancy\n* Patient refusal\n* Local sepsis\n* Inability to understand the study protocol or pain scale.'}, 'identificationModule': {'nctId': 'NCT02949661', 'briefTitle': 'Local Wound Infiltration for Tracheal Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.', 'orgStudyIdInfo': {'id': 'R ∕16.08.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Superficial cervical plexus block', 'description': 'Patients will receive bilateral superficial cervical plexus block using levobupivacaine', 'interventionNames': ['Procedure: Superficial cervical plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local wound infiltration', 'description': 'Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery', 'interventionNames': ['Procedure: Local wound infiltration']}], 'interventions': [{'name': 'Superficial cervical plexus block', 'type': 'PROCEDURE', 'description': 'Patients will receive bilateral superficial cervical plexus block', 'armGroupLabels': ['Superficial cervical plexus block']}, {'name': 'Local wound infiltration', 'type': 'PROCEDURE', 'description': 'Patients will receive local wound infiltration', 'armGroupLabels': ['Local wound infiltration']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hanaa M Elbendary, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}