Breast Prosthesis; PainRIB-BREASTNCT07448246
Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery
A study testing Rhomboid intercostal plane block in people with Breast Prosthesis; Pain and Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Prosthesis; Pain, Postoperative Pain, Breast Augmentation
- What is being tested?
- Rhomboid intercostal plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Neurological or psychiatric conditions interfering with pain assessment
- Body mass index (BMI) > 35 kg/m²
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation
Aydin, Efeler, 09010
Konul Karaja, Anesthesiology Research Fellow, +905550948199, konul2992@gmail.com
Kamil Varlık Erel, Prof, +905324439202, varlık.erel@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Rhomboid intercostal plane block
- Keywords
- Rhomboid Intercostal Block, RIB Block, Regional Anesthesia, Postoperative Analgesia, Breast Surgery, Tramadol PCA, Ultrasound-Guided Block
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid intercostal plane blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Feb 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Prosthesis; PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konul Karaja, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448246
- Sponsor's protocol ID
- ADU-RIPB-BREAST IMPLANT -2026
- Acronym
- RIB-BREAST
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Rhomboid Intercostal Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Bilateral Breast Implant Surgery: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07448246
- Acronym / sponsor ID
- RIB-BREAST / ADU-RIPB-BREAST IMPLANT -2026
- Keywords
- Rhomboid Intercostal Block, RIB Block, Regional Anesthesia, Postoperative Analgesia, Breast Surgery, Tramadol PCA, Ultrasound-Guided Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhomboid Intercostal Plane Block | Experimental | Procedure: Rhomboid intercostal plane blockUltrasound-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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhomboid intercostal plane blockUltrasound-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 | Procedure or surgery | Rhomboid Intercostal Plane Block |
Primary outcome
Total Tramadol Consumption Within the First 24 Hours Postoperatively
Time frame: 0 to 24 hours postoperatively
Total amount of tramadol (mg) administered via patient-controlled analgesia (PCA) during the first 24 postoperative hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation
Aydin, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhomboid intercostal plane block in people with Breast Prosthesis; Pain and Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Tramadol Consumption Within the First 24 Hours Postoperatively (time frame: 0 to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.