Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery (RIB-BREAST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Breast Augmentation; Breast Prosthesis; Pain
• Intervention / Treatment: Procedure: Rhomboid intercostal plane block

Detailed Description

This prospective, randomized, single-center, single-blind clinical study is designed to evaluate the postoperative analgesic efficacy of bilateral Rhomboid Intercostal Block (RIB) in patients undergoing elective bilateral breast prosthesis surgery.

Patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective bilateral breast prosthesis surgery will be screened for eligibility. After obtaining written informed consent, participants will be randomly allocated into two groups using a computer-generated randomization sequence.

Group RIB: Patients will receive ultrasound-guided bilateral Rhomboid Intercostal Block in addition to standardized general anesthesia.

Control Group: Patients will undergo surgery under standardized general anesthesia without any regional block intervention.

The RIB procedure will be performed under aseptic conditions using ultrasound guidance. For each side, a total volume of 30 mL local anesthetic solution will be administered. The solution will consist of 5 mL of 2% lidocaine, 10 mL of 0.25% bupivacaine, and 15 mL of 0.9% sodium chloride, ensuring that maximum safe dosage limits are not exceeded.

All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using intravenous tramadol via patient-controlled analgesia (PCA). Tramadol dosing will be calculated according to body weight, with a reference dose of 0.1 mg/kg. The PCA bolus dose will be set at one-quarter of this reference dose, and the hourly maximum limit will be set at twelve times the bolus dose.

Postoperative assessments will be conducted at 0, 1, 2, 6, 12, and 24 hours. Pain intensity will be measured using a validated Visual Analog Scale (VAS) or Numeric Rating Scale (NRS). Rescue analgesia will be administered when pain scores are ≥4, and additional analgesic consumption will be recorded.

The primary endpoint is total tramadol consumption within the first 24 postoperative hours. Secondary endpoints include pain scores at predefined time points, time to first analgesic requirement, need for rescue analgesia, incidence of postoperative nausea and vomiting, analgesia-related adverse effects, and block-related complications.

Data will be analyzed using appropriate statistical methods. The study will be conducted in accordance with ethical principles and will commence after approval from the institutional ethics committee.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Efeler
    • Aydin, Efeler, Turkey (Türkiye), 09010
      • Recruiting
      • Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation
      • Contact: Kamil Varlık Erel, Prof; Phone Number: +905324439202; Email: varlık.erel@gmail.com
      • Contact: Konul Karaja, Anesthesiology Research Fellow; Phone Number: +905550948199; Email: konul2992@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group (No Block); Patients in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.
Experimental: Rhomboid Intercostal Plane Block; Ultrasound-guided bilateral rhomboid intercostal plane block (RIPB) will be performed preoperatively under aseptic conditions while patients are awake. A total of 30 mL local anesthetic solution will be administered per side 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 5 mL of 2% lidocaine, 10 mL of 0.25% bupivacaine, and 15 mL of 0.9% normal saline, ensuring that maximum safe dosage limits are not exceeded.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Tramadol Consumption Within the First 24 Hours Postoperatively	Total amount of tramadol (mg) administered via patient-controlled analgesia (PCA) during the first 24 postoperative hours.	0 to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Postoperative Analgesia; Breast Surgery; Rhomboid Intercostal Block; Ultrasound-Guided Block; RIB Block; Tramadol PCA
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative
• Other Study ID Numbers: ADU-RIPB-BREAST IMPLANT -2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) underlying the results reported in this study, after de-identification, will be available upon reasonable request. Data will be shared beginning 6 months and ending 36 months following article publication. Proposals should be directed to the corresponding investigator. Data will be provided after approval of a methodologically sound proposal and with a signed data access agreement.
• IPD Sharing Time Frame: Available beginning 6 months after publication and ending 36 months after publication
• IPD Sharing Access Criteria: De-identified individual participant data (IPD), study protocol, statistical analysis plan, and analytic code will be available to qualified researchers who provide a methodologically sound research proposal. Requests should be directed to the corresponding investigator. Data will be shared after approval of the proposal and execution of a data access agreement. Data will be provided for purposes consistent with the original study objectives and ethical approvals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No