Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT04778267
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'randomization table created by a researcher who is not involved in the study. The researcher will assign the random ID to each patient and a blinded anesthesiologist will use this ID while collecting the postoperative data in the surgical ward. The block interventions of this study will be done by the same anesthesiologist (well trained to use US-guided regional techniques) while pre-operative and postoperative data collection will be done by another anesthesiologist blinded to the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The effectiveness of combined ultrasound guided erector spinae and pectointercostal fascial plane blocks versus ultrasound guided thoracic paravertebral block in controlling perioperative pain in modified radical mastectomy, a blinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The first time to ask for rescue analgesia post-operatively', 'timeFrame': '48 hours', 'description': 'after how many hours postoperatively the patient will ask for analgesia'}], 'secondaryOutcomes': [{'measure': 'The total postoperative opioid consumption (in the first 48 hrs)', 'timeFrame': '48 hours', 'description': 'total milligrams of opioid given to the patient in the 48 hours postoperatively'}, {'measure': 'NRS scores', 'timeFrame': '48 hours postoperative', 'description': 'Postoperative pain will be assessed, using numeric rating scale (NRS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Modified Radical Mastectomy']}, 'descriptionModule': {'briefSummary': 'Erector spinae plane block (ESPB) is a new evolving fascial pain block in the era of regional anaesthesia. ESPB was applied in varieties of surgeries and provided an eminent role in trauma patient especially those with fracture ribs. ESPB exhibits simple, safe and easy technique with minimal or no sympathetic blockade effects, thus gaining popularity in wide range of surgeries. The optimum effective dose of local anaesthetic, the effective volume of drug used for desired dermatomes. Comparison with different regional blocks is preferable to know the optimum analgesic technique for those population of patients (4). Many studies have already compared solo ESPB with thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), serratus anterior plane block (SAPB) and pectoral nerves block. Only few case reports described the combination effect of rhomboid intercostal, transversus thoracic muscle and parasternal plane blocks to ESPB in modified radical mastectomy.', 'detailedDescription': 'patients scheduled for modified radical mastectomy and axillary dissection under general anesthesia (GA) will be included in the study. The patients will be randomly allocated by a computer-generated table into one of the two study groups.Thoracic paravertebral block group (TPV group) and combined erector spinae and pecto-intercostal fascial plane blocks group (ES-PI group).\n\n0.25% bupivacaine and 1 mg dexamethasone will be injected with different volumes in each block.\n\nThe first time to ask for rescue analgesia post-operatively will be measured. Using MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium), 24 patients (12 patients per group) were calculated for a relative difference of 10% (0.635 hours) in the time to first analgesic request between both groups, with a study power of 95% and an alpha error of 0.05. This number will be increased to 30 patients (15 patients per group) to compensate for possible dropouts.\n\nAnalysis of data will be performed using the Statistical Package for Social Science (SPSS) software, version 21 for Microsoft Windows (SPSS Inc., Chicago, iL, USA). Categorical data will be reported as numbers and percentages and will be analyzed using the chi-squared test. Continuous data will be checked for normality using the Kolmogorov-Smirnov test. Normally distributed data will be presented as means (standard deviations) and will be analyzed using the unpaired student t-test. Skewed data will be expressed as medians(quartiles) and will be analyzed using the Mann Whitney U test. For repeated measures, a two-way repeated measures ANOVA will be used to evaluate block (between-groups factor) and time (repeated measures)". Post-hoc pairwise comparison will be performed using the Bonferroni test. A P value of 0.05 or less will be considered significant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • 18-60 years of age\n\n * ASA I-II\n * Elective unilateral modified radical mastectomy with axillary lymph node dissection\n * Body weight (50-90 kg)\n\nExclusion Criteria:\n\n* • Patient refusal\n\n * Known allergy to any of the study drugs\n * Bleeding disorders (platelets \\< 50 000, PC \\<60%, INR\\>1.5)\n * Infection at the site of needle puncture or sepsis\n * Obesity (BMI \\> 30 kg/m2)\n * Chronic opioid user eg; morphine addict\n * Chronic pain disease eg certain cancer patients, rheumatological disease\n * Inability to comprehend or use the numeric rating pain scoring system\n * Psychiatric illness eg, psychiatric patients on hypnotic treatment'}, 'identificationModule': {'nctId': 'NCT04778267', 'briefTitle': 'Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'The Effectiveness of Combined U.S. Guided Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus U.S.Guided Thoracic Paravertebral Block in Controlling Perioperative Pain in Modified Radical Mastectomy, a Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MD-342-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TPVB (thoracic paravertebral block)', 'description': 'TPVB will be performed in the sitting position A high frequency linear ultrasound probe will be applied in the parasagittal plane approximately 2-3 cm lateral to the midline till identification of the 3rd thoracic vertebra (T3) in the same side of surgery. Then the transducer will be moved progressively more medially until transverse processes are identified.The image acquired will have the transverse process located superiorly and an image of lower rib located inferiorly on the screen.The needle tip is to be observed to enter through the superior costotransverse ligament and loss of resistance sensation will be experienced. After confirming the anterior displacement of pleura with 2-3 mL of local anesthetic (LA), 30 ml of 0.25% bupivacaine and 4 mg dexamethasone will be administered for the block.', 'interventionNames': ['Drug: Bupivacaine Hydrochloride', 'Drug: Dexamethasone phosphate']}, {'type': 'EXPERIMENTAL', 'label': 'ES-PI (erector spinae-pectointercostal block)', 'description': 'ESPB In the second group (ES-PI) Using a high frequency linear ultrasound probe, it will be located in a longitudinal orientation at the level of T3 spinous process and then will be placed 3 cm laterally from the midline to the side involved in the surgery. .a 22-gauge block needle will be inserted in-plane at an angle of 30-40°. 20 mL of 0.25% bupivacaine hydrochloride and 3 mg dexamethasone will be injected in the plane deeper to the erector spinae muscle.\n\nPIPB While the patient is in the supine position, a high frequency linear probe will be placed parallel to the long axis of the sternum at a distance 2-3 cm from the attachment of the second rib and sternum to identify the Pectoralis major muscle, external intercostal muscles and the second rib in the superficial plane. by separation of fascial layers of between the external intercostal and the pectoralis muscles, a total of 10 ml of 0.25% bupivacaine and 1 mg dexamethasone will be injected.', 'interventionNames': ['Drug: Bupivacaine Hydrochloride', 'Drug: Dexamethasone phosphate']}], 'interventions': [{'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': 'We hypothesize that combined ESPB and PIPB are as effective as TPVB in controlling perioperative pain in patients undergoing modified radical mastectomy (MRM) with lesser complications using bupivacaine hydrocloride', 'armGroupLabels': ['ES-PI (erector spinae-pectointercostal block)', 'TPVB (thoracic paravertebral block)']}, {'name': 'Dexamethasone phosphate', 'type': 'DRUG', 'otherNames': ['decadrone'], 'description': 'used as additive to bupivacaine', 'armGroupLabels': ['ES-PI (erector spinae-pectointercostal block)', 'TPVB (thoracic paravertebral block)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2222', 'city': 'Cairo', 'state': 'Kasr Al Aini', 'country': 'Egypt', 'facility': 'Kase Al Aini teaching hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Sara Farouk Kassem Habib', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}