Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04586751
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Pecs Blocks on Postmastectomy Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D059373', 'term': 'Mastodynia'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-05', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score 6 hours postoperatively', 'timeFrame': '6 hours after surgery', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}, {'measure': 'pain score 12 hours postoperatively', 'timeFrame': '12 hours after surgery', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}, {'measure': 'pain score 24 hours postoperatively', 'timeFrame': '24 hours after surgery', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}], 'secondaryOutcomes': [{'measure': 'incidence of chronic pain', 'timeFrame': '3 months after surgery', 'description': 'occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement'}, {'measure': 'incidence of chronic pain', 'timeFrame': '6 months after surgery', 'description': 'occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement'}, {'measure': 'time of first request for analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'time of first request for analgesia after the operation'}, {'measure': 'analgesic consumption in mg of morphine', 'timeFrame': '24 hours postoperatively', 'description': 'additional analgesic consumption in the first 24 hours after the operation'}, {'measure': 'satisfaction from postoperative analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction'}, {'measure': 'Pecs block related complications', 'timeFrame': '48 hours postoperatively', 'description': 'Pecs block-related complications at the site of the local anesthetic injection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Syndrome', 'Pain, Postoperative', 'Chronic Pain', 'Breast Cancer', 'Breast Soft Tissue Neoplasm', 'Breast Neoplasms', 'Breast Cancer Female', 'Breast Pain', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '25376971', 'type': 'BACKGROUND', 'citation': 'Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.'}, {'pmid': '30386013', 'type': 'BACKGROUND', 'citation': 'Thomas M, Philip FA, Mathew AP, Jagathnath Krishna KM. Intraoperative pectoral nerve block (Pec) for breast cancer surgery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):318-323. doi: 10.4103/joacp.JOACP_191_17.'}, {'pmid': '24796220', 'type': 'BACKGROUND', 'citation': 'Sykioti P, Zis P, Vadalouca A, Siafaka I, Argyra E, Bouhassira D, Stavropoulou E, Karandreas N. Validation of the Greek Version of the DN4 Diagnostic Questionnaire for Neuropathic Pain. Pain Pract. 2015 Sep;15(7):627-32. doi: 10.1111/papr.12221. Epub 2014 May 5.'}, {'pmid': '20562750', 'type': 'BACKGROUND', 'citation': 'Bras M, Dordevic V, Gregurek R, Bulajic M. Neurobiological and clinical relationship between psychiatric disorders and chronic pain. Psychiatr Danub. 2010 Jun;22(2):221-6.'}, {'pmid': '28949315', 'type': 'BACKGROUND', 'citation': 'Dujmovic A, Marcinko D, Bulic K, Kisic H, Dudukovic M, Mijatovic D. Quality of Life and Depression Among Female Patients Undergoing Surgical Treatment for Breast Cancer: A Prospective Study. Psychiatr Danub. 2017 Sep;29(3):345-350. doi: 10.24869/psyd.2017.345.'}, {'pmid': '20832052', 'type': 'BACKGROUND', 'citation': 'Khan RS, Ahmed K, Blakeway E, Skapinakis P, Nihoyannopoulos L, Macleod K, Sevdalis N, Ashrafian H, Platt M, Darzi A, Athanasiou T. Catastrophizing: a predictive factor for postoperative pain. Am J Surg. 2011 Jan;201(1):122-31. doi: 10.1016/j.amjsurg.2010.02.007. Epub 2010 Sep 15.'}, {'pmid': '31564259', 'type': 'BACKGROUND', 'citation': 'Najeeb HN, Mehdi SR, Siddiqui AM, Batool SK. Pectoral Nerves I, II and Serratus Plane Blocks in Multimodal Analgesia for Mastectomy: A Randomised Clinical Trial. J Coll Physicians Surg Pak. 2019 Oct;29(10):910-914. doi: 10.29271/jcpsp.2019.10.910.'}], 'seeAlsoLinks': [{'url': 'http://www.painconcern.org.uk', 'label': 'contains news, features and comments on every topic that matters to the pain community'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms', 'detailedDescription': 'Breast cancer is the commonest type of malignancy in women. Chronic postoperative neuropathic pain may appear either in the early postoperative period or at a later stage, usually 3-6 months post-operatively. Chronic post-operative pain syndrome of any magnitude usually involves 19-57% of patients that have undergone any kind of surgical procedure, while 5% of them experience intense symptoms. Risk factors for developing post-mastectomy pain syndrome include younger age, increased Body mass Index (BMI), psychological profile, co-existence of other painful conditions, pre-operative radiotherapy/chemotherapy, type of surgical procedure and anaesthesia, persistent acute postoperative pain, etc. Consequently, chronic post mastectomy pain syndrome results in significant psychosomatic sequelae with variable social impacts for the female patients.\n\nThe aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms.\n\nDuring the preoperative visit, the women will be informed about the study and will be instructed to the use of the pain numeric rating scale (NRS) graded from 0 to 10. Standardized anesthesia will be administered. All patients will receive 1000 mg of paracetamol and 0.07 mg/ Kg of morphine intraoperatively. In the Post-Anesthesia Care Unit (PACU), patients will receive additional morphine boluses on request, until NRS score is lesser or equal than 4. Postoperative nausea and vomiting will be treated with ondansetron 4 mg iv. After discharge from PACU, patients will receive a combination of paracetamol 1 gr/6h and im pethidine 75 mg on request, as per hospital protocol.\n\nNumerical rating scores (NRS) at rest and movement will be measured at 6h, 12h and 24h postoperatively. Additionally, the time to first request for analgesia after surgery will be noted.\n\nAll patients will also be evaluated 3 and 6 months after surgery with the use of NRS at rest and movement and additionally, via the use of Douleur Neuropathique (DN4) questionnaire for the occurence of neuropathic pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I-III patients\n* Breast cancer patients\n* Patients who receive operative treatment\n\nExclusion Criteria:\n\n* inability to consent to the study due to language barriers or cognitive dysfunction -\n* skin infection at the puncture site\n* contraindication to paracetamol administration\n* known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers"}, 'identificationModule': {'nctId': 'NCT04586751', 'briefTitle': 'The Impact of Pecs Blocks on Postmastectomy Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Aretaieion University Hospital'}, 'officialTitle': 'The Impact of Pecs Blocks on the Appearance of Post Mastectomy Chronic Pain Symptoms', 'orgStudyIdInfo': {'id': 'Breast-Nektaria'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group', 'description': 'Pecs block under real-time ultrasound guidance after anesthesia induction will be performed. In specific, using the in-plane insertion technique, after visualization of the entire needle as a bright hyperechoic line and aiming between pectoralis major and pectoralis minor at the 3rd rib level, 2 ml of normal saline 09% will be injected first, to verify the correct position of the needle. Followingly, 10 mL ropivacaine 0.5% will be injected in order to block the lateral and medial pectoral nerves. Finally, another 15 ml of ropivacaine 0.5% plus 4 mg of dexamethasone will be injected between the pectoralis minor muscle and the anterior serratus muscle,at the level of the 4th and 5th ribs, after negative aspiration, to block the intercostal and intercostobrachial nerves. Using the color Doppler the vessels will be identified, so that their puncture is avoided during the procedures.', 'interventionNames': ['Other: Pecs block']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'no regional block will be performed', 'interventionNames': ['Other: no Pecs block']}], 'interventions': [{'name': 'Pecs block', 'type': 'OTHER', 'description': 'Pecs block under real-time ultrasound guidance after anesthesia induction will be performed.', 'armGroupLabels': ['study group']}, {'name': 'no Pecs block', 'type': 'OTHER', 'description': 'no regional block will be performed in this arm', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Limassol', 'country': 'Cyprus', 'facility': 'General Hospital of Limassol', 'geoPoint': {'lat': 34.68406, 'lon': 33.03794}}, {'city': 'Nicosia', 'country': 'Cyprus', 'facility': 'General Hospital of Nicosia', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}, {'zip': '115 28', 'city': 'Athens', 'country': 'Greece', 'facility': 'Aretaieion University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Kassiani Theodoraki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aretaieion University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aretaieion University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Dr Kassiani Theodoraki', 'investigatorAffiliation': 'Aretaieion University Hospital'}}}}