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Recruiting Not applicable

Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery

NCT07448246 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-02-15
Last updated
2026-03-04

Condition(s) studied

Breast Prosthesis; PainPostoperative PainBreast Augmentation

Investigational drug(s) / intervention(s)

Rhomboid intercostal plane block

Rhomboid intercostal plane block: Ultrasound-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

Study 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

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Total Tramadol Consumption Within the First 24 Hours Postoperatively — 0 to 24 hours postoperatively
    Total amount of tramadol (mg) administered via patient-controlled analgesia (PCA) during the first 24 postoperative hours.

Trial sites (1)

FacilityCityRegionStatus
Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation Aydin Efeler Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07448246 on ClinicalTrials.gov ↗ ← All trials in Turkey