An interventional study of Rhomboid intercostal plane block in Breast Prosthesis; Pain, Postoperative Pain and Breast Augmentation, sponsored by Aydin Adnan Menderes University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Treatment
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.
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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.
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
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.
Time frame: 0 to 24 hours postoperatively
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aydin Adnan Menderes University