Postoperative PainRSMRMNCT07659990
RISS Versus SPSIP Block in Modified Radical Mastectomy
A study testing Rhomboid Intercostal-Subserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Postoperative Pain and Breast Cancer, run by Ferit Yetik at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain, Breast Cancer
- What is being tested?
- Rhomboid Intercostal-Subserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2026to Nov 2026
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-75 years
- ASA physical status I-III
- Scheduled for elective unilateral modified radical mastectomy with axillary dissection under general anesthesia
- Provision of written informed consent
Who cannot join
- Anticoagulant therapy
- Bleeding diathesis
- Known allergy to local anesthetics or opioids
- Infection at the block application site or previous surgery in the block area
- Cognitive impairment preventing NRS assessment
- Pregnancy or lactation
Show all 10Show fewer
- Chronic opioid use
- Severe hepatic or renal failure
- Refusal to participate in the study
- Technical inability to perform the block or failed block
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
Bursa City Hospital
Bursa, Nilüfer, 16100
Yusuf Alan, MD, 05396210977, dryusufalan@gmail.com
About this study
Official title: Comparison of Rhomboid Intercostal-Subserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia and Dermatomal Spread After Modified Radical Mastectomy: A Randomized Double-Blind Trial
This prospective randomized double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Postoperative pain scores, opioid consumption, rescue analgesic requirements, block-related complications, and quality of recovery outcomes will be evaluated.
Read the detailed description
Breast cancer surgery is frequently associated with moderate to severe postoperative pain, which may negatively affect recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia strategies for breast surgery.
The rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block are recently described regional anesthesia techniques that may provide effective postoperative analgesia by blocking the lateral and posterior branches of the thoracic spinal nerves. However, comparative clinical evidence regarding their analgesic efficacy and dermatomal coverage in modified radical mastectomy remains limited.
This prospective randomized double-blind controlled trial will compare RISS block and SPSIP block in adult patients undergoing modified radical mastectomy under general anesthesia. Participants will be randomly allocated to receive either RISS block or SPSIP block before surgery. The primary objective is to compare postoperative opioid consumption. Secondary outcomes include postoperative pain scores, dermatomal sensory spread, time to first rescue analgesia, quality of recovery, opioid-related adverse events, and block-related complications.
- Conditions
- Postoperative Pain, Breast Cancer
- Being tested
- Rhomboid Intercostal-Subserratus Plane Block, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Breast Neoplasms, Postoperative Pain, Anesthesia, Conduction
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid Intercostal-Subserratus Plane BlockProcedure or surgery
Ultrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Ultrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| RISS Block | Experimental | Patients will receive an ultrasound-guided rhomboid intercostal-subserratus plane (RISS) block before modified radical mastectomy for postoperative analgesia. Receives: Procedure: Rhomboid Intercostal-Subserratus Plane Block |
| SPSIP Block | Experimental | Patients will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before modified radical mastectomy for postoperative analgesia. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Opioid Consumption
Total opioid consumption during the first 24 hours after modified radical mastectomy.
Measured: 24 hours after surgery
Secondary outcomes (6)
Postoperative Pain Scores
Postoperative pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Measured: 0-24 hours after surgery
Compartmental Pain Scores Using Numeric Rating Scale
Numeric Rating Scale (NRS) score (0-10 points) measured separately for axillary pain, anterolateral chest wall pain, and surgical drain insertion site pain. A score of 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 0-24 hours after surgery
Dermatomal Sensory Block Distribution
Number of dermatomes blocked, assessed by pinprick sensory testing 30 minutes after block performance. Higher values indicate wider sensory block distribution.
Measured: 30 minutes after block performance
Quality of Recovery-15 Score
Quality of Recovery-15 (QoR-15) questionnaire score ranging from 0 to 150, where higher scores indicate better postoperative recovery and patient satisfaction.
Measured: 24 hours after surgery
Intraoperative Remifentanil Consumption
Total intraoperative remifentanil consumption will be recorded and compared between groups.
Measured: During surgery
Block- and Opioid-Related Complications
Complications related to block performance and opioid use will be recorded.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start19 Jun 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a Rhomboid Intercostal-Subserratus Plane (RISS) block or a Serratus Posterior Superior Intercostal Plane (SPSIP) block before modified radical mastectomy. Outcomes will be compared between two parallel groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferit Yetik
- Sponsor type
- Other government
- Collaborators
- Bursa City Hospital
- Responsible party
- Sponsor-investigator, Ferit Yetik, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Mürsel Ekinci, MD, Principal investigator, Bursa City HospitalYusuf Alan, MD, Study chair, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659990
- Sponsor's protocol ID
- MRM-2025-KAEK47
- Other IDs
- 2025-KAEK-47
- Acronym
- RSMRM
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rhomboid Intercostal-Subserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia and Dermatomal Spread After Modified Radical Mastectomy: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07659990
- Acronym / sponsor ID
- RSMRM / MRM-2025-KAEK47
- Conditions
- Postoperative Pain, Breast Cancer
- Keywords
- Breast Neoplasms, Postoperative Pain, Anesthesia, Conduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ferit YetikOther government
- Collaborators
- Bursa City Hospital
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jun 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 double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Postoperative pain scores, opioid consumption, rescue analgesic requirements, block-related complications, and quality of recovery outcomes will be evaluated.
Detailed description
Breast cancer surgery is frequently associated with moderate to severe postoperative pain, which may negatively affect recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia strategies for breast surgery.
The rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block are recently described regional anesthesia techniques that may provide effective postoperative analgesia by blocking the lateral and posterior branches of the thoracic spinal nerves. However, comparative clinical evidence regarding their analgesic efficacy and dermatomal coverage in modified radical mastectomy remains limited.
This prospective randomized double-blind controlled trial will compare RISS block and SPSIP block in adult patients undergoing modified radical mastectomy under general anesthesia. Participants will be randomly allocated to receive either RISS block or SPSIP block before surgery. The primary objective is to compare postoperative opioid consumption. Secondary outcomes include postoperative pain scores, dermatomal sensory spread, time to first rescue analgesia, quality of recovery, opioid-related adverse events, and block-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a Rhomboid Intercostal-Subserratus Plane (RISS) block or a Serratus Posterior Superior Intercostal Plane (SPSIP) block before modified radical mastectomy. Outcomes will be compared between two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| RISS Block | Experimental | Procedure: Rhomboid Intercostal-Subserratus Plane BlockPatients will receive an ultrasound-guided rhomboid intercostal-subserratus plane (RISS) block before modified radical mastectomy for postoperative analgesia. |
| SPSIP Block | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockPatients will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before modified radical mastectomy for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18-75 years
- ASA physical status I-III
- Scheduled for elective unilateral modified radical mastectomy with axillary dissection under general anesthesia
- Provision of written informed consent
Key exclusion criteria (10 listed)
- Anticoagulant therapy
- Bleeding diathesis
- Known allergy to local anesthetics or opioids
- Infection at the block application site or previous surgery in the block area
- Cognitive impairment preventing NRS assessment
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-Subserratus Plane BlockUltrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia. | Procedure or surgery | RISS Block |
| Serratus Posterior Superior Intercostal Plane BlockUltrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia. | Procedure or surgery | SPSIP Block |
Primary outcome
Total Postoperative Opioid Consumption
Time frame: 24 hours after surgery
Total opioid consumption during the first 24 hours after modified radical mastectomy.
6 secondary outcomes
Postoperative Pain Scores
Time frame: 0-24 hours after surgery
Compartmental Pain Scores Using Numeric Rating Scale
Time frame: 0-24 hours after surgery
Dermatomal Sensory Block Distribution
Time frame: 30 minutes after block performance
Quality of Recovery-15 Score
Time frame: 24 hours after surgery
Intraoperative Remifentanil Consumption
Time frame: During surgery
Block- and Opioid-Related Complications
Time frame: 24 hours after surgery
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 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mürsel Ekinci, MD principal investigator
Bursa City Hospital
Yusuf Alan, MD study chair
Bursa City Hospital
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-Subserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Postoperative Pain and Breast Cancer, run by Ferit Yetik 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 10 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 24 Jun 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?
Contact Yusuf Alan, MD (+905396210977, dryusufalan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postoperative Opioid Consumption (time frame: 24 hours after surgery). 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 24 Jun 2026.