Breast CancerRIBSABNCT05547932
The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions
A study testing RIB+SAP blocks in people with Breast Cancer and Postoperative Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Pain, Respiratory Function Impaired
- What is being tested?
- RIB+SAP blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2022to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ASA I-II patients
- Female
- Ages between 18-65
- Patients who will receive breast cancer surgery under general anesthesia
Who cannot join
- Known respiratory diseases
- Rhinitis and atopic dermatitis story
- New York Heart Association Class equal to higher than class 2
- Respiratory diseases story in the last two weeks
- Alchol or substance or chronic opioid consumption story
- Any pain killers intake in the last 24 hours prior to surgery
Show all 12Show fewer
- Active smokers or ex-smokers
- Body mass index over 35 kg/m2
- İnfection at the injection sites
- Known allergy to local anesthetics
- Known psychiatric diseases
- Operations longer than 3 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery
Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.
Read the detailed description
The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.
- Being tested
- RIB+SAP blocks
- Keywords
- Analgesia, postoperative pain, rhomboid intercostal block, serratus anterior plane block, respiratory function
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Respiratory Insufficiency, Agnosia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIB+SAP blocksProcedure or surgery
RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Block Group | Experimental | After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 20 ml of bupivacaine 0.25%. In the same position, the probe will be placed at the midaxillary line at the level of T3, and the landmark points (latissimus dorsi muscle and serratus muscle and intercostal muscles) will be observed. Under sterile conditions, a SAP block will be performed by injecting 20 ml of Bupivacaine 0.25% into the plane between serratus muscle and intercostal muscle. Receives: Procedure: RIB+SAP blocks |
| Control Group | No intervention | No block procedures will be performed in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Measured: postoperative 2nd hour
Secondary outcomes (6)
Postoperative pain
The pain scores of the patients in the block group will be lower than the patients in the control group at the postoperative second hour.
Measured: Postoperative second hour
Postoperative opioid consumption
The opioid consumption of the patients in the block group will be lower than the patients in the control group at the postoperative 24th hour.
Measured: Postoperative 24th hour
Forced Vital Capacity (FVC)
FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Measured: postoperative 2nd hour
FEV1/FVC
FEV1/FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Measured: postoperative 2nd hour
forced expiratory flow at 25-75% of forced vital capacity (FEF25-75)
FEF25-75 values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Measured: postoperative 2nd hour
Peak expiratory flow (PEF)
PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Measured: postoperative 2nd hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start21 Sep 2022
- Primary completion13 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak Altıparmak, Muğla Sıtkı Koçman University
- Investigators
- Bakiye Uğur, MD, Study chair, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547932
- Sponsor's protocol ID
- MSK8/22
- Acronym
- RIBSAB
- Status last verified
- Apr 2023
- First submitted
- 10 Aug 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with anyone
Publications
Akgun G, Altiparmak B, Pinarbasi A, Toker MK, Pektas S, Ugur B. Impact of ultrasound-guided rhomboid intercostal and serratus anterior plane blocks on respiratory function after modified radical mastectomy: a randomized controlled trial. Korean J Anesthesiol. 2026 Feb;79(1):104-113. doi: 10.4097/kja.25150. Epub 2025 Jun 26.
PubMed 40567200
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery
- ClinicalTrials.gov ID
- NCT05547932
- Acronym / sponsor ID
- RIBSAB / MSK8/22
- Keywords
- Analgesia, postoperative pain, rhomboid intercostal block, serratus anterior plane block, respiratory function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 21 Sep 2022 (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.
Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.
Detailed description
The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Block Group | Experimental | Procedure: RIB+SAP blocksAfter endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 20 ml of bupivacaine 0.25%. In the same position, the probe will be placed at the midaxillary line at the level of T3, and the landmark points (latissimus dorsi muscle and serratus muscle and intercostal muscles) will be observed. Under sterile conditions, a SAP block will be performed by injecting 20 ml of Bupivacaine 0.25% into the plane between serratus muscle and intercostal muscle. |
| Control Group | No intervention | –No block procedures will be performed in this group. |
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)
- ASA I-II patients
- Female
- Ages between 18-65
- Patients who will receive breast cancer surgery under general anesthesia
Key exclusion criteria (12 listed)
- Known respiratory diseases
- Rhinitis and atopic dermatitis story
- New York Heart Association Class equal to higher than class 2
- Respiratory diseases story in the last two weeks
- Alchol or substance or chronic opioid consumption story
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 |
|---|---|---|
| RIB+SAP blocksRIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients. | Procedure or surgery | Block Group |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: postoperative 2nd hour
FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
6 secondary outcomes
Postoperative pain
Time frame: Postoperative second hour
Postoperative opioid consumption
Time frame: Postoperative 24th hour
Forced Vital Capacity (FVC)
Time frame: postoperative 2nd hour
FEV1/FVC
Time frame: postoperative 2nd hour
forced expiratory flow at 25-75% of forced vital capacity (FEF25-75)
Time frame: postoperative 2nd hour
Peak expiratory flow (PEF)
Time frame: postoperative 2nd hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 40567200Akgun G, Altiparmak B, Pinarbasi A, Toker MK, Pektas S, Ugur B. Impact of ultrasound-guided rhomboid intercostal and serratus anterior plane blocks on respiratory function after modified radical mastectomy: a randomized controlled trial. Korean J Anesthesiol. 2026 Feb;79(1):104-113. doi: 10.4097/kja.25150. Epub 2025 Jun 26.
- Individual participant dataSharing planned: No. IPD will not be shared with anyone
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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. This study is not recruiting at the moment.
Bakiye Uğur, MD study chair
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIB+SAP blocks in people with Breast Cancer and Postoperative Pain, run by Muğla Sıtkı Koçman 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 12 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: finished, as of the sponsor's last update on 19 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in 1 second (FEV1) (time frame: postoperative 2nd hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547932, which also lists 1 linked publication.
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 19 Apr 2023.