Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT03602794
Status:
UNKNOWN
Last Update Posted:
2018-09-05
First Post:
2018-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-07-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-03', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption in 24 hour after surgery', 'timeFrame': '24 hour', 'description': 'Total morphine consumption in 24 hour after surgery'}], 'secondaryOutcomes': [{'measure': 'Duration of analgesia', 'timeFrame': '24 hours', 'description': 'time to first rescue analgesia after administration of block'}, {'measure': 'Postoperative pain score.', 'timeFrame': '24 hours', 'description': 'Post op pain score will be assessed using a visual analogue scale (VAS, 0-10; 0 = no pain and 10 = worst imaginable pain). The vital signs and pain score will be recorded at 0, 0.5, 1, 2, 4, 6, 8, 12, and 24 h after surgery by the attending staff nurses blinded to the group allocation'}, {'measure': 'Adverse Effects', 'timeFrame': '24 hours', 'description': 'Any adverse effects will be recorded (such as hypotension, respiratory depression, pruritus, shivering and urinary retention)'}, {'measure': 'Postoperative nausea vomiting (PONV)', 'timeFrame': '24 hours', 'description': 'Postoperative nausea vomiting (PONV)'}, {'measure': 'Intraoperative analgesia', 'timeFrame': '24 hours', 'description': 'total usage of IV Fentanyl intraoperatively'}, {'measure': 'Operative time', 'timeFrame': '24 hrs', 'description': 'duration of surgery'}, {'measure': 'Block performance time', 'timeFrame': '24 hours', 'description': 'time from needle insertion until needle exit from the skin'}, {'measure': 'Block related complications', 'timeFrame': '24 hours', 'description': 'pneumothorax'}, {'measure': 'Block related complications', 'timeFrame': '24 hours', 'description': 'vascular puncture'}, {'measure': 'Block related complications', 'timeFrame': '24 hours', 'description': 'local anaesthetic toxicity'}, {'measure': 'Post-operative complications', 'timeFrame': '24 hours', 'description': 'Bleeding'}, {'measure': 'Post-operative complications', 'timeFrame': '24 hours', 'description': 'Wound infection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mastectomy; Lymphedema', 'Local Infiltration', 'Anesthesia, Local', 'Block']}, 'referencesModule': {'references': [{'pmid': '22939099', 'type': 'BACKGROUND', 'citation': 'Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.'}], 'seeAlsoLinks': [{'url': 'http://dx.doi.org/10.1016/j.redar.2012.07.003', 'label': 'Ultrasound description of Pecs II (modified Pecs I): A novel approacj to breast surgery'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance for patients undergoing mastectomy with axillary dissection.', 'detailedDescription': 'Total breast removal with armpit dissection may be a painful surgery. Pectoral nerve block (Pecs block) is common pain relief method used to reduce pain after breast surgery.\n\nThe Pecs block is a pain relief method technique at targeted body part. The Pecs block numbs nerves which supply sensation to the upper chest wall, armpit and upper arm. This procedure is only possible under ultrasound guidance and is carried out by the anaesthetist (medical specialist who administers anaesthetics) after patients are put under general anaesthesia.\n\nDespite the advantages of Pecs block in pain management, this method is not always available to all patients due to various reasons. These reasons include the availability of ultrasound machine to facilitate the method, presence of anaesthetist to carry out the procedure and additional time required to perform this method in the operating theatre.\n\nAnother method has been modified by our surgeons (medical specialist who performs surgery, a different specialty from anaesthetist) to achieve pain relief among patients undergoing breast removal surgery. This method is called local infiltration analgesia (LIA). The pain control is achieved by having the surgeons to deliver a pain control drug surgically during the breast removal operation. LIA could be a good pain control alternative when a Pecs block could not be performed.\n\nThe investigators hope to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance. The investigators hope to show that LIA delivered by surgeon is as effective as Pecs block in patients undergoing mastectomy with axillary dissection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age above 21 years old\n* Able to give consent\n* Body weight \\> 50kg\n\nExclusion Criteria:\n\n* Patient's refusal and inability to give consent\n* Allergy or contraindicated to local anaesthetics, paracetamol, NSAIDS or opioids\n* Background history of chronic pain\n* Bilateral procedures"}, 'identificationModule': {'nctId': 'NCT03602794', 'briefTitle': 'A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study', 'orgStudyIdInfo': {'id': '2017/2894'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PECs Block', 'description': 'Total local anaesthetic dose: 30ml ropivacaine 0.5%\n\n•Pecs block will be performed by anaesthetist using ultrasound guidance in plane approach: 10ml ropivacaine 0.5% will be delivered at the plane between pectoralis major and pectoralis minor, another 20ml ropivacaine 0.5% will be delivered in the plane between the pectoralis minor and serratus anterior muscles at the level of the third and fourth ribs', 'interventionNames': ['Procedure: PECs Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Local Infiltration', 'description': 'LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles.', 'interventionNames': ['Procedure: Local infiltration']}], 'interventions': [{'name': 'PECs Block', 'type': 'PROCEDURE', 'description': 'Regional Anaesthesia Technique ie Pectoralis Nerve Block under ultrasound guidance', 'armGroupLabels': ['PECs Block']}, {'name': 'Local infiltration', 'type': 'PROCEDURE', 'description': 'LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles.', 'armGroupLabels': ['Local Infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Kwee Lian Woon', 'role': 'CONTACT', 'phone': '+65 81211037'}], 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Kwee Lian Woon', 'role': 'CONTACT', 'email': 'Kwee_Lian_Woon@cgh.com.sg', 'phone': '+6581211037'}], 'overallOfficials': [{'name': 'Kwee Lian Woon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louis Ng Xiang Long', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Co- Investigator', 'investigatorFullName': 'Louis Ng Xiang Long', 'investigatorAffiliation': 'Changi General Hospital'}}}}