Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery
Recruiting now · Not applicable
Conditions studied: Breast Prosthesis; Pain, Postoperative Pain, Breast Augmentation
In brief
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.
Key facts
- Study ID
- NCT07448246
- Run by
- Aydin Adnan Menderes University
- People needed
- 40
- Starts
- 2026-02-15
- Expected to finish
- 2027-04-15
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Chronic opioid use or chronic pain syndromes
- Severe hepatic, renal, or cardiac disease
- Neurological or psychiatric conditions interfering with pain assessment
- Body mass index (BMI) > 35 kg/m²
- Pregnancy or breastfeeding
Where it is running
- Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation — Aydin, Efeler, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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