RecruitingNot ApplicableNCT07448246

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

The Effect of Bilateral Rhomboid Intercostal Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Bilateral Breast Implant Surgery: A Prospective Controlled Study


Sponsor

Aydin Adnan Menderes University

Enrollment

40 participants

Start Date

Feb 15, 2026

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

PROCEDURERhomboid 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


Locations(1)

Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation

Aydin, Efeler, Turkey (Türkiye)

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NCT07448246


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