Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT07448246

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

Led by Aydin Adnan Menderes University · Updated on 2026-03-04

40

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Refusal to participate
  • Known allergy or hypersensitivity to lidocaine, 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/m�b2
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation

Aydin, Efeler, Turkey (Türkiye), 09010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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