Breast Cancer Clinical Trial
— RIBSABOfficial title:
The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery
Verified date | April 2023 |
Source | Mugla Sitki Koçman University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.
Status | Completed |
Enrollment | 64 |
Est. completion date | April 14, 2023 |
Est. primary completion date | April 13, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - ASA I-II patients - Female - Ages between 18-65 - Patients who will receive breast cancer surgery under general anesthesia Exclusion Criteria: - Known respiratory diseases - Rhinitis and atopic dermatitis story - New York Heart Association Class equal to higher than class 2 - Respiratory diseases story in the last two weeks - Alchol or substance or chronic opioid consumption story - Any pain killers intake in the last 24 hours prior to surgery - Active smokers or ex-smokers - Body mass index over 35 kg/m2 - Infection at the injection sites - Known allergy to local anesthetics - Known psychiatric diseases - Operations longer than 3 hours |
Country | Name | City | State |
---|---|---|---|
Turkey | Mugla Sitki Koçman University | Mugla |
Lead Sponsor | Collaborator |
---|---|
Mugla Sitki Koçman University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced Expiratory Volume in 1 second (FEV1) | FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group | postoperative 2nd hour | |
Secondary | Postoperative pain | The pain scores of the patients in the block group will be lower than the patients in the control group at the postoperative second hour. | Postoperative second hour | |
Secondary | Postoperative opioid consumption | The opioid consumption of the patients in the block group will be lower than the patients in the control group at the postoperative 24th hour. | Postoperative 24th hour | |
Secondary | Forced Vital Capacity (FVC) | FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group | postoperative 2nd hour | |
Secondary | FEV1/FVC | FEV1/FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group | postoperative 2nd hour | |
Secondary | forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) | FEF25-75 values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group | postoperative 2nd hour | |
Secondary | Peak expiratory flow (PEF) | PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group | postoperative 2nd hour |
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