Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-02 @ 9:58 AM
Study NCT ID:
NCT04427904
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2020-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], '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'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000083', 'term': 'Acetanilides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '30 minutes after surgery', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative Pain', 'timeFrame': '1 hour after surgery', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative Pain', 'timeFrame': '2 hours after surgery', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative Pain', 'timeFrame': '3 hours after surgery', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative Pain', 'timeFrame': '4 hours after surgery', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative Pain', 'timeFrame': '8 hours after surgery', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative Pain', 'timeFrame': '12 hours after surgery', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}], 'secondaryOutcomes': [{'measure': 'First dose of additional postoperative analgesia', 'timeFrame': 'Up to 72 hours after surgery', 'description': 'Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered'}, {'measure': 'Inpatient analgesia utilization', 'timeFrame': 'Up to 72 hours after surgery', 'description': 'Quantity of standardized analgesia used during admission'}, {'measure': 'Outpatient analgesia utilization', 'timeFrame': 'Up to 4 weeks after surgery', 'description': 'Quantity of standardized analgesia used between discharge and 4 week outpatient follow up'}, {'measure': 'Time to return of sensation', 'timeFrame': 'Up to 4 weeks after surgery', 'description': 'Patient reported time to return of sensation at surgical site'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': '4 weeks', 'description': 'Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia'}, {'measure': 'Incidence of local anesthesia related adverse events', 'timeFrame': '4 weeks', 'description': 'Incidence of adverse events including CNS (tinnitus, blurred vision, dizziness, tongue paresthesias, circumoral numbness, seizures, CNS depression) and cardiovascular (hear block, sinus bradycardia, sinus arrest, ventricular arrhythmias) events.'}, {'measure': 'Postoperative pain', 'timeFrame': '1 week', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative pain', 'timeFrame': '2 week', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}, {'measure': 'Postoperative pain', 'timeFrame': '4 week', 'description': 'Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroidectomy', 'Bupivacaine', 'Lidocaine'], 'conditions': ['Postoperative Pain', 'Thyroid Diseases', 'Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.', 'detailedDescription': 'Patients planned for total thyroidectomy will be recruited for participation. After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility for study entry. Patients that meet inclusion and exclusion criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or Lidocaine (2% with 1:100 000 epinephrine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of thyroid disease (malignant tumors T1-T3/NX-N1a, benign tumors)\n* Planned for thyroid surgery with midline neck incision (total thyroidectomy, completion thyroidectomy, with or without central neck dissection)\n* Will be admitted for at least 12h postoperatively\n\nExclusion Criteria:\n\n* Thyroid cancer staged as T4 (invasion, anaplastic) or requiring sternotomy\n* Thyroid cancer staged as N1b (cervical, retropharyngeal, superior mediastinal nodal involvement)\n* Previous ipsilateral thyroid surgery to operation side\n* Previous total thyroidectomy or completion thyroidectomy\n* History of neck radiation therapy\n* Neck dissection beyond central neck (levels 1-5)\n* Goiter extending beyond sternal notch (intrathoracic) or requiring sternotomy\n* Surgery requiring extension of incision beyond 8 cm\n* History of diabetes mellitus\n* History of renal or liver disease\n* History of narcotic abuse\n* History of chronic pain medications use in past 6 months for any condition\n* History of coagulation defect\n* Allergy to Bupivacaine or Lidocaine'}, 'identificationModule': {'nctId': 'NCT04427904', 'briefTitle': 'Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Healthcare Hamilton"}, 'officialTitle': 'Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '7336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine', 'description': 'Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.', 'interventionNames': ['Drug: Bupivacaine 0.5% with 1:200 000 epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.', 'interventionNames': ['Drug: Lidocaine 2% with 1:100 000 epinephrine']}], 'interventions': [{'name': 'Bupivacaine 0.5% with 1:200 000 epinephrine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.', 'armGroupLabels': ['Bupivacaine']}, {'name': 'Lidocaine 2% with 1:100 000 epinephrine', 'type': 'DRUG', 'otherNames': ['Xylocaine'], 'description': 'Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.', 'armGroupLabels': ['Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N4A6', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michael Xie, MD', 'role': 'CONTACT', 'email': 'michael.xie@medportal.ca', 'phone': '(905) 522-1155', 'phoneExt': '4765'}, {'name': 'Han Zhang, MD FRCSC', 'role': 'CONTACT', 'email': 'hanzhang@stjosham.on.ca', 'phone': '(905) 521-2100', 'phoneExt': '37031'}], 'facility': "St. Joeseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Michael Xie, MD', 'role': 'CONTACT', 'email': 'michael.xie@medportal.ca', 'phone': '(905) 522-1155', 'phoneExt': '4765'}, {'name': 'Han Zhang, MD FRCSC', 'role': 'CONTACT', 'email': 'hanzhang@stjosham.on.ca', 'phone': '(905) 521-2100', 'phoneExt': '37031'}], 'overallOfficials': [{'name': 'Han Zhang, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Hospital Hamilton"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician', 'investigatorFullName': 'Michael Xie', 'investigatorAffiliation': "St. Joseph's Healthcare Hamilton"}}}}