Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:48 AM
Study NCT ID:
NCT01089933
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2010-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Pain and Disability After Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mchiu@toh.ca', 'phone': '613-798-5555', 'title': 'Dr Michelle Chiu', 'phoneExt': '14169', 'organization': 'OHRI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'through study completion, an average of 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Thoracic PVB + Multimodal Anesthesia', 'description': 'Thoracic PVB + multimodal anesthesia\n\nThoracic Paravertebral Block (TPVB): The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Local Anesthetic + Multi-modal Analgesia', 'description': 'Local anesthetic + multi-modal analgesia\n\nLocal Anesthetic: At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.', 'otherNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic PVB + Multimodal Anesthesia', 'description': 'Thoracic PVB + multimodal anesthesia\n\nThoracic Paravertebral Block (TPVB): The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.'}, {'id': 'OG001', 'title': 'Local Anesthetic + Multi-modal Analgesia', 'description': 'Local anesthetic + multi-modal analgesia\n\nLocal Anesthetic: At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Arm Morbidity, Shoulder Range of Motion, Quality of Analgesia, Arm Lymphedema, Time to Meet Discharge Criteria, Quality of Recovery, Quality of Life, Incidence of Postoperative Side Effects.', 'timeFrame': '1 year', 'description': 'Brief Pain Inventory (BPI); Flexion, extension, abduction, internal, and external rotation of the shoulder; Constant score; Quality of life was assessed using the FACTB4 and the SF-12 Health Survey (SF12); Details of the surgery, chemotherapy, and/or radiation therapy were recorded', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thoracic PVB + Multimodal Anesthesia', 'description': 'Thoracic PVB + multimodal anesthesia\n\nThoracic Paravertebral Block (TPVB): The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.'}, {'id': 'FG001', 'title': 'Local Anesthetic + Multi-modal Analgesia', 'description': 'Local anesthetic + multi-modal analgesia\n\nLocal Anesthetic: At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thoracic PVB + Multimodal Anesthesia', 'description': 'Thoracic PVB + multimodal anesthesia\n\nThoracic Paravertebral Block (TPVB): The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.'}, {'id': 'BG001', 'title': 'Local Anesthetic + Multi-modal Analgesia', 'description': 'Local anesthetic + multi-modal analgesia\n\nLocal Anesthetic: At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '56', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '55', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'survey was done to collect participant age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2010-03-17', 'resultsFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2010-03-18', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-05', 'studyFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Arm Morbidity, Shoulder Range of Motion, Quality of Analgesia, Arm Lymphedema, Time to Meet Discharge Criteria, Quality of Recovery, Quality of Life, Incidence of Postoperative Side Effects.', 'timeFrame': '1 year', 'description': 'Brief Pain Inventory (BPI); Flexion, extension, abduction, internal, and external rotation of the shoulder; Constant score; Quality of life was assessed using the FACTB4 and the SF-12 Health Survey (SF12); Details of the surgery, chemotherapy, and/or radiation therapy were recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Local Anesthetics', 'Analgesia', 'Quality of life', 'Paravertebral blocks', 'Arm morbidity'], 'conditions': ['Breast Cancer', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '24165901', 'type': 'RESULT', 'citation': 'Chiu M, Bryson GL, Lui A, Watters JM, Taljaard M, Nathan HJ. Reducing persistent postoperative pain and disability 1 year after breast cancer surgery: a randomized, controlled trial comparing thoracic paravertebral block to local anesthetic infiltration. Ann Surg Oncol. 2014 Mar;21(3):795-801. doi: 10.1245/s10434-013-3334-6. Epub 2013 Oct 29.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1245/s10434-013-3334-6', 'label': 'full publication, including results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the combination of thoracic paravertebral block and multimodal analgesia will decrease chronic pain and arm morbidity in patients undergoing breast cancer surgery with lymph node dissection as compared to patients receiving local anesthesia with multimodal analgesia.', 'detailedDescription': "Sixty percent of breast cancer patients undergo some form of breast surgery in the treatment of the early stages of the disease. The recovery from surgery can be associated with severe disabling pain persisting beyond 12 months after surgery. Research in pain has shown that early intervention of acute pain can prevent long term chronic pain.\n\nAt The Ottawa Hospital, patients receive either paravertebral blocks or wound infiltration with local anesthetic for postoperative pain management. We would like to compare these two methods of pain control to determine an analgesic technique that will reduce acute and chronic pain, and maximally improve long-term functional recovery and patient's quality of life."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of breast cancer\n* Scheduled for elective modified radical mastectomy, simple mastectomy with SLNB, breast conserving surgery (ie lumpectomy, segmental mastectomy) with ALND or ALND alone (after positive SLNB)\n\nExclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) class 4 or 5\n* Patients with contraindications to TPVB\n* Allergy to study medications\n* Chronic opioid use defined as daily consumption of greater than 20 mg of oral morphine or equivalent for \\>7days\n* Renal insufficiency defined as a creatinine clearance \\<40ml/min as calculated using the Cockroft-Gault formula\n* Preoperative radiation therapy\n* Inability to achieve normal shoulder range of motion as defined as \\<100o of shoulder abduction or flexion'}, 'identificationModule': {'nctId': 'NCT01089933', 'acronym': 'RELIeF', 'briefTitle': 'Reducing Pain and Disability After Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection', 'orgStudyIdInfo': {'id': '2006711-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thoracic PVB + multimodal anesthesia', 'description': 'Thoracic PVB + multimodal anesthesia', 'interventionNames': ['Procedure: Thoracic Paravertebral Block (TPVB)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local anesthetic + multi-modal analgesia', 'description': 'Local anesthetic + multi-modal analgesia', 'interventionNames': ['Procedure: Local Anesthetic']}], 'interventions': [{'name': 'Thoracic Paravertebral Block (TPVB)', 'type': 'PROCEDURE', 'otherNames': ['Regional analgesia; neural blockade'], 'description': 'The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.', 'armGroupLabels': ['Thoracic PVB + multimodal anesthesia']}, {'name': 'Local Anesthetic', 'type': 'PROCEDURE', 'otherNames': ['local anesthesia'], 'description': 'At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.', 'armGroupLabels': ['Local anesthetic + multi-modal analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Michelle Chiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital / Ottawa Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Breast Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}