NCT06756048

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

Study of the Effects of Rhomboid Intercostal Block on Acute Postoperative Pain Management and Chronic Pain Incidence in Patients Undergoing Oncologic Breast Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Koç University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Outcome Measures The primary outcome is the prevalence of chronic pain at 3 months in patients undergoing mastectomy surgery. For patients reporting pain, additional parameters will be assessed, including: Pain characteristics: location, frequency, intensity, and radiation. Factors that exacerbate or alleviate pain. Impact of pain on quality of life (measured on a 1-5 scale). Types and quantities of analgesics used. Secondary Outcome Measures Acute Pain Scores: Pain levels at 1, 6, 12, and 24 hours postoperatively at rest, measured using the Numeric Rating Scale (NRS). Opioid Consumption and Side Effects: Total opioid consumption (morphine and tramadol) within the first 24 hours postoperatively. Incidence of opioid-related side effects, such as nausea, vomiting, and pruritus. Patient Satisfaction and Sleep Quality: Satisfaction with the analgesic method (e.g., very satisfied, satisfied, neutral, dissatisfied, very dissatisfied). Sleep quality ratings (very good, good, moderate, poor, very poor). Willingness to use the same analgesic method again (yes/no). Chronic Pain Impact on Daily Life (for patients with pain at 3 months): Degree of limitation in physical activities, household/work tasks, and social life (scored on a scale from 0 = no limitation to 5 = constant limitation). Impact on psychological well-being (scored on a scale from 0 = no impact to 5 = constant impact). Study Design and Participants This prospective, randomized, controlled study will be conducted at Koç University Hospital. Participants will include 90 patients undergoing elective mastectomy surgery, aged 18-80 years, and classified as ASA I-III according to the American Society of Anesthesiologists. Written informed consent will be obtained from all participants. The sample size calculation was based on a 2020 meta-analysis reporting a 59% prevalence of chronic pain at 3 months in patients without any regional block. Using select-statistics.co.uk software, with a two-proportion sample test, a 50% reduction in chronic pain prevalence was considered significant. With a p-value of 0.05 and 80% power, 43 patients per group were required. To increase robustness and account for potential dropouts, 45 patients per group (90 total) will be enrolled. Randomization and Blinding: Participants will be randomized into two groups using randomizer.org software. RIB will be performed before induction of general anesthesia. No blinding will be performed due to the nature of the intervention.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2025-01-01
• Last updated: 2025-01-01

Locations

1 site across 1 country: Turkey (Türkiye)