Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAydin Adnan Menderes University
About this trial
This prospective, randomized, single-center, study aims to evaluate the postoperative analgesic effectiveness of bilateral Rhomboid Intercostal Block (RIB) in patients undergoing elective bilateral breast prosthesis surgery. Effective postoperative pain management is essential to improve patient comfort and reduce opioid consumption.
Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to either receive ultrasound-guided bilateral RIB block in addition to standard general anesthesia or undergo surgery without any regional block (control group). All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia (PCA) with intravenous tramadol.
The primary outcome of the study is total tramadol consumption within the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at predefined time points, time to first analgesic requirement, need for rescue analgesia, incidence of nausea and vomiting, and block-related complications.
The results of this study will help determine whether bilateral RIB block provides superior postoperative pain control compared to standard analgesic management alone in bilateral breast prosthesis surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18-65 years
American Society of Anesthesiologists (ASA) physical status I-II
Scheduled for elective bilateral breast prosthesis surgery
Ability to understand the study protocol and provide written informed consent
Disqualifiers
Refusal to participate
Known allergy or hypersensitivity to local anesthetics (lidocaine or bupivacaine) or tramadol
Coagulation disorders or current anticoagulant therapy
Infection at the injection site
Trial design
Design model
Parallel
Treatments tested in this trial
Rhomboid intercostal plane block
Procedure/SurgeryUltrasound-guided bilateral rhomboid intercostal plane block performed preoperatively under aseptic conditions while patients are awake. A total of 30 mL local anesthetic solution per side will be injected between the rhomboid major muscle and the intercostal muscles at the medial border of the scapula around the 5th intercostal level. The local anesthetic mixture will consist of lidocaine and bupivacaine diluted with normal saline, ensuring that maximum safe dosage limits are not exceeded
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Rhomboid Intercostal Plane BlockExperimental treatment 1 intervention
Group B: Control Group (No Block)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total Tramadol Consumption Within the First 24 Hours Postoperatively
Total amount of tramadol (mg) administered via patient-controlled analgesia (PCA) during the first 24 postoperative hours.
Time frame
0 to 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov