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

NCT07448246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-04

No results posted yet for this 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.

Conditions

  • Breast Prosthesis; Pain
  • Postoperative Pain
  • Breast Augmentation

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Aydin Adnan Menderes University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2027-02-15
Completion
2027-04-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448246 on ClinicalTrials.gov