Muğla Sıtkı Koçman University
Muğla, 48000, Turkey (Türkiye)
NCT Number: NCT05547932
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.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
Muğla, 48000, Turkey (Türkiye)
The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.
Time frame: postoperative 2nd hour
FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Time frame: Postoperative second hour
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.
Time frame: Postoperative 24th hour
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.
Time frame: postoperative 2nd hour
FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Time frame: postoperative 2nd hour
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
Time frame: postoperative 2nd hour
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
Time frame: postoperative 2nd hour
PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Muğla Sıtkı Koçman University
Other
The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery
Acronym: RIBSAB
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