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IRCT20211215053419N1 IRCT 2022-02-26 Iran University of Medical Sciences Efficacy of ultrasound guided pectoral nerve block versus serratus anterior block on pain Comparison of efficacy of ultrasound guided pectoral nerve block (PECS II) versus serratus anterior block (SAB) on postoperative pain in breast cancer surgery 2022-03-06 anticipated 80 Complete https://irct.ir/trial/60902 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Patients will be randomly assigned to two groups by using a random number table. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 4. In each block, 2 individuals will be in intervention group 1 and 2 will be in intervention group 2. A total of 20 blocks will be considered for the study. Random Block Quadruple All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 20 blocks to select 80 people. We randomly select these blocks from 1 to 6. Using the software, we choose a random number between the numbers 1 to 6. For example, if the number 6 is selected as the first block and the number 2 as the second block, the people who enter the study will be given BAABAABB, respectively. Finally, group A receives control intervention and group B receives treatment intervention, Blinding description: Patients will be unaware and blind to the type of treatment. Similar envelopes were used for hiding, without the name tag of the block method and only with the code. Patients will be aware that they will be randomly assigned to one of two treatment groups, but will not know which treatment will be offered in that group. Patients will be placed in one of two groups using a table of random numbers. The data collector and analyst will collect and analyze the information based on groups 1 and 2, and will not be aware of the type of treatment provided in the groups and will be kept blind. N/A Breast cancer. Intervention 1: Intervention group 1: Type II pectoral nerve block. The block will be performed after general anesthesia. The purpose of this block is to penetrate the two fascia compartments by dividing the dose of local anesthesia between the pectoral nerve in the pectoralis minor muscle. This block is performed by placing the patient supine and placing the surgical side arm in a 90 degree position. The linear transducer is located on the outer side of the midline of the clavicle at the level of the third rib, and in the first injection approximately 0.2 ml per kg of ropivacine is injected 0.25 between the pectoralis major and minor muscles, for lateral and medial pectoral nerve blocks. The transducer is rotated slightly to create a path for the needle from the top and inside to the side. While the second injection was in the axillary anterior line and at the level of the fourth gear with 0.2 ml per kg of ropivacine 0.25 between the pectoralis minor and the anterior ceratus muscle, using a linear transducer with a depth of 1 to 4 cm and a needle. Local block is performed. The injection depth is usually 1 to 3 cm for the first injection and 3 to 6 cm for the second injection. Intervention 2: Intervention group 2:Anterior Ceratus block under ultrasound guide. The block will be performed after general anesthesia under an ultrasound guide with a portable ultrasound device. In this block the linear transducer is located on the midaxillary line and at the level of the fifth gear. A block needle is inserted from the outer edge of the transducer and moves forward until the tip of the needle reaches each plate between the thoracic fascia on the ultrasound image. Following the detection of ultrasound signs, a linear transducer with a depth of 1 to 4 cm and a local block needle can be performed and an injection of 0.4 ml per kg of ropivacaine 0.25 block will be performed. Device model: Portable Sono Site, HFL50X/15-6 MHz Trancducer، Made in USA.
public Parinaz Morovati Sharif Abadi
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 4608 8077 parinazmorovati43589@gmail.com Iran University of Medical Sciences scientific Parinaz Morovati Sharif Abadi
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 4608 8077 parinazmorovati43589@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old Candidate for lumpectomy or partial mastectomy Perform surgery under general anesthesia 18 years 60 years Female Prohibition of any nerve block History of bleeding disease Drug allergy History of liver or kidney failure Obesity Pregnancy or lactation History of drugs addiction History of neurological diseases Infection of the site of the block History of breast surgery Patients over 60 years old C50 Malignant neoplasm of breast Treatment - Surgery Treatment - Surgery Intervention group 1: Type II pectoral nerve block. The block will be performed after general anesthesia. The purpose of this block is to penetrate the two fascia compartments by dividing the dose of local anesthesia between the pectoral nerve in the pectoralis minor muscle. This block is performed by placing the patient supine and placing the surgical side arm in a 90 degree position. The linear transducer is located on the outer side of the midline of the clavicle at the level of the third rib, and in the first injection approximately 0.2 ml per kg of ropivacine is injected 0.25 between the pectoralis major and minor muscles, for lateral and medial pectoral nerve blocks. The transducer is rotated slightly to create a path for the needle from the top and inside to the side. While the second injection was in the axillary anterior line and at the level of the fourth gear with 0.2 ml per kg of ropivacine 0.25 between the pectoralis minor and the anterior ceratus muscle, using a linear transducer with a depth of 1 to 4 cm and a needle. Local block is performed. The injection depth is usually 1 to 3 cm for the first injection and 3 to 6 cm for the second injection. Intervention group 2:Anterior Ceratus block under ultrasound guide. The block will be performed after general anesthesia under an ultrasound guide with a portable ultrasound device. In this block the linear transducer is located on the midaxillary line and at the level of the fifth gear. A block needle is inserted from the outer edge of the transducer and moves forward until the tip of the needle reaches each plate between the thoracic fascia on the ultrasound image. Following the detection of ultrasound signs, a linear transducer with a depth of 1 to 4 cm and a local block needle can be performed and an injection of 0.4 ml per kg of ropivacaine 0.25 block will be performed. Device model: Portable Sono Site, HFL50X/15-6 MHz Trancducer، Made in USA. The amount of pain. Timepoint: 6, 12 and 24 hours after surgery. Method of measurement: Based on Numerical Rating Scale. Patient satisfaction. Timepoint: 6, 12 and 24 hours after surgery. Method of measurement: Based on Likert scale. Patient analgesia. Timepoint: 6, 12 and 24 hours after surgery. Method of measurement: Ramsay sedation scale. Total dose of anesthesia. Timepoint: After surgery. Method of measurement: Based on patient records. Iran University of Medical Sciences Approved 2021-12-04 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)