Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.


Clinical Trial Description

Patients will be randomly allocated into three groups based on a computerized randomization table with specific ID for each patient (23 per group). Each patient will be prepared in Preoperative Holding Area with sedation with midazolam 0.05mg/kg patients allotted to the RIB group were positioned in the lateral decubitus position with the breast on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RISS was performed after application of antiseptic solution. A high-frequency using a 6-13 MHz linear ultrasound probe set to B mode (SonoSite M-turbo ultrasound machine) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, a 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected. All block procedures were performed by the same anesthesiologist who had administered the RIB and RISS blocks in more than 30 cases before this study. In control group (Group C), no block intervention was performed. After disinfection, using 30 mL of levobupivacaine 0.25% (10 mL between pectoralis minor muscle and pectoralis major muscle, and 20 mL between the pectoralis major muscle and serratus muscle). With the patient in supine position. (Group B) After shifting to the operative area, all patients underwent conventional monitoring procedures including electrocardiography, noninvasive monitoring of blood pressure, and peripheral oxygen saturation measurements. Intravenous access was gained using a 22-gauge intravenous needle, and isotonic saline was infused at a rate of 15 mL kg-1 h-1. Anesthetic management was in accordance with a standard protocol. Anesthesia was induced with pre-oxygenation for 3 min followed by intravenous injection of midazolam (0.05 mg/kg), fentanyl (0.1 µg/kg), propofol (1-2 mg/kg), and atracurium (0.5 mg/kg). An endotracheal tube was used for positive-pressure ventilation to maintain the end-tidal carbon dioxide level of 35-40 mmHg. Anesthesia was maintained using 2% sevoflurane with 50% oxygen, fentanyl (0.1 µg kg-1 min-1), and propofol (100 µg kg-1 min-1). Additionally, atracurium (0. 1 mg/kg) was administered according to the surgical protocol. Surgery (Unilateral conservative mastectomy) was started. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. If the blood pressure decreased by > 20% from the baseline value, 250 mL of 0.9% (physiologic) saline and ephedrine (0.1 mg/kg) were administered. If the heart rate decreased to less than 50 bpm, atropine (0.5 mg/kg) was administered. At the end of the surgery, the effect of atracurium was reversed using neostigmine and atropine as needed. After the surgery, the endotracheal tube was removed when the patient fulfills criteria of extubation. Then the patient will be transferred to the PACU. Data will be collected: A. Intraoperative assessment: (readings will be taken just after induction and every 15 min throughout surgery) 1. Heart rate intraoperative. 2. Mean arterial blood pressure intraoperative. 3. Analgesic consumption: recorded during intraoperative period to maintain maximum 20% change of basal vital signs after exclusion of other causes. (Intraoperative fentanyl consumption) B. Postoperative: 1. Recovery time: the time taken to be fully awake and responding to commands. 2. Pain score: VAS score at 0, 3, 6, 9,24h post-operative. 3. Hemodynamic: pulse, B.P (systolic, diastolic, and mean blood pressure) at 0,3,6,9,24h postoperative. 4. Side effects (nausea, vomiting, hematoma, hypotension, bradycardia). 5. Rescue analgesia plane will be given for VAS≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine). Time of the first rescue analgesia together with frequency and total dose of the given drug through the 24 hours will be recorded. 6. Hospital discharge. Primary outcome: 1. Total morphine consumption in first 24 hours post operative. 2. VAS score postoperative. Secondary outcome: 1. Heart rate intraoperative. 2. Mean arterial blood pressure intraoperative. 3. Timing of first rescue analgesia. 4. Intraoperative fentanyl consumption. 5. Side effects (nausea, vomiting, hematoma, hypotension, bradycardia). 6. Body mass index (BMI). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06274814
Study type Interventional
Source National Cancer Institute, Egypt
Contact ahmed soliman
Phone 00201286979695
Email ams21787arif@hotmail.com
Status Recruiting
Phase N/A
Start date June 1, 2023
Completion date May 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT03980626 - Study on Physical Activity's Relationship With Cancer and Cognition N/A
Completed NCT04329819 - Satisfaction and QUality of Life After Breast REconstruction
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Active, not recruiting NCT03900884 - Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer Phase 1
Completed NCT05042999 - The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures N/A
Not yet recruiting NCT03662633 - Diagnosis Value of SEMA4C in Breast Cancer
Recruiting NCT05075512 - The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer Phase 2
Recruiting NCT04456855 - Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Not yet recruiting NCT03629509 - BEFORE Decision Aid Implementation Study N/A
Completed NCT04811378 - HaemoCerTM Application in Breast Cancer Surgery N/A
Completed NCT03198442 - Breast PET Feasibility N/A
Not yet recruiting NCT05577442 - Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer Phase 2
Enrolling by invitation NCT04047823 - Temperature and Injury in Radiotherapy Radiation Skin Injury
Recruiting NCT05452213 - Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients Phase 4
Recruiting NCT05027321 - Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies N/A
Active, not recruiting NCT04812652 - Digitally Distributed Yoga for Women Treated for Breast Cancer N/A
Active, not recruiting NCT03425838 - Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer Phase 3
Completed NCT05473026 - Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors N/A
Completed NCT04509063 - Investigating Public Enthusiasm for Mammography Screening in Denmark N/A
Recruiting NCT05711030 - Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery N/A