Bilateral rhomboid intercostal block to reduce pain after breast implant surgery
Official title: The Effect of Bilateral Rhomboid Intercostal Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Bilateral Breast Implant Surgery: A Prospective Controlled Study
Run by Aydin Adnan Menderes University · NCT07448246 · Data updated 2026-11-12
This trial will test whether adding an ultrasound-guided bilateral rhomboid intercostal block to general anesthesia reduces pain and tramadol use after elective bilateral breast implant surgery in adults aged 18–65.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Aydin Adnan Menderes University Academic / other |
| Locations | 1 site (Aydin, Efeler) |
| Status | Recruiting |
| Started | February 15, 2026 |
| Main results expected | February 15, 2027 |
| Study ends | April 15, 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07448246 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women aged 18–65 with ASA physical status I–II who are scheduled for elective bilateral breast prosthesis surgery, able to consent, not chronically using opioids, and without major comorbidities are the intended participants.
✕Probably not a fit
Patients with contraindications to regional anesthesia (coagulopathy, infection at the site), allergies to the local anesthetics or tramadol, chronic opioid use, BMI >35, pregnancy or severe organ disease are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this single-center, randomized, single-blind study, adults scheduled for elective bilateral breast prosthesis surgery are assigned to receive either an ultrasound-guided bilateral rhomboid intercostal block plus standardized general anesthesia or general anesthesia alone. The block uses a defined mixture of lidocaine and bupivacaine administered under ultrasound guidance on both sides. All patients receive standardized intraoperative care and postoperative patient-controlled analgesia with intravenous tramadol. The primary outcome is total tramadol consumption in the first 24 postoperative hours, with secondary outcomes including pain scores, time to first analgesic request, rescue analgesia need, and nausea incidence.
Why it matters
Potential benefit: If effective, the block could lower early postoperative pain and reduce opioid (tramadol) use and related side effects after breast implant surgery.
How similar studies have gone: Small trials and case series of the rhomboid intercostal block and other chest-wall plane blocks have reported reduced postoperative pain and opioid use after breast surgery, but large high-quality randomized data remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation
Aydin, Efeler, Turkey (Türkiye) Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.