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Effects of Rhomboid Intercostal Block on Postoperative Pain Management and Chronic Pain Incidence in Mastectomies

NCT06756048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-01-01

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effects of the Rhomboid Intercostal Block (RIB) on postoperative chronic pain prevalence at 3 months (primary outcome) and on acute pain control, total opioid consumption, and the incidence of opioid-related side effects within the first 24 hours (secondary outcomes) in patients undergoing elective mastectomy surgery.

The main questions it aims to answer are:

Does the application of RIB reduce the prevalence of chronic pain at 3 months postoperatively? Does RIB improve acute pain control and reduce opioid consumption and related side effects in the first 24 hours postoperatively? Researchers will compare patients who receive RIB under general anesthesia to those who do not receive the block to determine its effectiveness in reducing chronic pain prevalence, acute pain scores, and opioid-related outcomes.

Conditions

  • Mastectomy
  • Rhomboid Intercostal Block
  • Chronic Pain Following Surgical Procedure for Cancer

Interventions

PROCEDURE

Rhomboid Intercostal Nerve Block

Following standard ASA monitoring, patients were positioned on the surgical table with their backs facing the operator. Skin antisepsis was achieved using povidone. A high-frequency 8-18 MHz linear ultrasound probe was used. After palpating the rhomboid muscles and intercostal spaces at the T6-T7 levels, the medial border of the scapula and the vertebral column were identified. The ultrasound probe was placed horizontally along the medial border of the scapula. Using ultrasound guidance, the ribs, rhomboid muscles, intercostal muscles, and pleura were visualized. Once these anatomical structures were clearly identified, a 50 mm, 22G regional block needle was advanced in-plane from caudal to cranial under ultrasound guidance until the interfascial plane beneath the rhomboid muscles was reached and total of 20 ml of 0.25% bupivacaine (Marcaine® 0.5%, AstraZeneca PLC, London, UK) was injected.

Sponsors & Collaborators

  • Koç University

    lead OTHER

Principal Investigators

  • Yavuz Gürkan, Prof. · Koc University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2024-11-27
Completion
2024-11-27

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 NCT06756048 on ClinicalTrials.gov