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

NCT07448246 | Recruiting

• 1 other identifier: ADU-RIPB-BREAST IMPLANT -2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rhomboid Intercostal Block; RIB Block; Regional Anesthesia; Postoperative Analgesia; Breast Surgery; Tramadol PCA; Ultrasound-Guided Block

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rhomboid Intercostal Plane Block

EXPERIMENTAL

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

Control Group (No Block)

NO INTERVENTION

Patients in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.

Interventions

Rhomboid intercostal plane block PROCEDURE

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

Rhomboid Intercostal Plane Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Eligibility is limited to biologically female patients undergoing elective bilateral breast prosthesis surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation

Aydin, Efeler, 09010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 4, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Available beginning 6 months after publication and ending 36 months after publication
• 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.

Locations

TU (1)