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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation
RECRUITING
Aydin
Time Frame
Start Date: 2026-02-15
Estimated Completion Date: 2027-04-15
Participants
Target number of participants: 40
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Aydin Adnan Menderes University

This content was sourced from clinicaltrials.gov