NCT07448246 Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery
| NCT ID | NCT07448246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aydin Adnan Menderes University |
| Condition | Breast Prosthesis; Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-15 |
| Primary Completion | 2027-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-02-15 with a primary completion date of 2027-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT07448246 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Breast Prosthesis; Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07448246 currently recruiting?
Yes, NCT07448246 is actively recruiting participants. Visit ClinicalTrials.gov or contact Aydin Adnan Menderes University to inquire about joining.
Where is the NCT07448246 trial being conducted?
This trial is being conducted at Aydin, Turkey (Türkiye).
Who is sponsoring the NCT07448246 clinical trial?
NCT07448246 is sponsored by Aydin Adnan Menderes University. The trial plans to enroll 40 participants.