Modified Radical MastectomyNCT07670078
Comparıson of Analgesıc Effıcacy of Dıfferent Volumes of Serratus Posterior Superıor Intercostal Plane Block After Modıfıed Radıcal Mastectomy Surgery
A study testing Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine and Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine in people with Modified Radical Mastectomy and Post Operative Pain, Acute, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of researchers is to compare the effects of three different local anesthetic concentrations and volumes on opioid consumption, postoperative analgesic efficacy, and pain scores during ultrasound-guided SPSIP blocks in patients undergoing modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Modified Radical Mastectomy, Post Operative Pain, Acute, Facial Plane Blocks
- What is being tested?
- Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine and Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2026to 30 Aug 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
- The study included adult patients over 18 years of age who underwent modified radical mastectomy under general anesthesia and were classified in risk groups I-II-III according to the American Society of Anesthesiologists (ASA) risk classification.
Who cannot join
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients with ASA IV
- patients with known allergies to any of the study drugs,
- patients with ineffective block
- patients who could not cooperate during postoperative pain assessment
Show all 11Show fewer
- patients who wanted to withdraw from the study,
- patients with alcohol and drug addiction,
- patients with musculoskeletal abnormalities
- patients with kidney and liver failure
- patients with obesity (body mass ≥ 35 kg/m2)
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
Sivas Cumhuriyet University
Sivas, Sivas, 58140
Oğuz Gündoğdu, +905544595469, oguzgundogdu@cumhuriyet.edu.tr
About this study
Official title: Comparıson of Analgesıc Effectıveness of Dıfferent Volumes of Serratus Posterıor Superıor Intercostal Plane Block In Patıents Undergoıng Modıfıed Radıcal Mastectomy Surgery
The aim of researchers is to compare the effects of three different local anesthetic concentrations and volumes on opioid consumption, postoperative analgesic efficacy, and pain scores during ultrasound-guided SPSIP blocks in patients undergoing modified radical mastectomy. Additionally, we aim to map and identify the dermatomal areas where different concentrations and volumes of SPSIP blocks provide analgesia.
Read the detailed description
The researchers' hypothesis is that a lower concentration but higher volume of SPSIP block could provide similar analgesic efficacy to a higher concentration and lower volume block, while also improving the safety profile in terms of local anesthetic systemic toxicity by reducing the total local anesthetic load. In other words, we believe that using less than the 0.25% bupivacaine used in previous studies on this block could provide similar analgesic efficacy. This is because, in fascial plane blocks, separating the fascia is as important a technique as the local anesthetic administered. Facial plane blocks are volume-dependent blocks.
The Modified Aldrete scoring system is a routine assessment performed in our clinic's postoperative recovery room to determine whether a patient has recovered. Patients with an NRS score of 4 or higher, despite routine analgesia, will receive 50 mg tramadol hydrochloride as a rescue analgesic, administered intravenously over 30 minutes in 150 ml of saline solution.
- Being tested
- Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine
- Keywords
- postoperative pain, regional anesthesia, Modified radical mastectomy, opioid free analgesia, facial plan block, serratus posterior superior intercostal plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaineProcedure or surgery
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.1875% bupivacaine (15 ml of the drug + 25 ml of isotonic solution).
Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaineProcedure or surgery
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.15% bupivacaine (15 ml of the drug + 35 ml of isotonic solution).
Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaineProcedure or surgery
A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution).
| Study group | Role | What they receive |
|---|---|---|
| 30 ml of 0.25% Bupivacaine | Active comparator | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution). Receives: Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine |
| 40 ml of 0.1875% Bupivacaine | Active comparator | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.1875% bupivacaine (15 ml of the drug + 25 ml of isotonic solution). Receives: Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine |
| 50 ml of 0.15% bupivacaine | Active comparator | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.15% bupivacaine (15 ml of the drug + 35 ml of isotonic solution). Receives: Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tramadol consumption
Postoperative total analgesic need was recorded as "milligram" in unit.
Measured: Postoperative 24 hours
Secondary outcomes (2)
Dermatome Area
Thirty minutes after the block procedure, we will perform a pinprick test by inserting a sterile needle from the tip of the syringe into the patient's skin and recording the areas where skin analgesia has developed.
Measured: 30th minute after the block
Numeric Rating Scale (NRS) Scores
Description: Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start25 Aug 2026 (estimated)
- Primary completion25 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670078
- Sponsor's protocol ID
- 2026-06/47
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparıson of Analgesıc Effectıveness of Dıfferent Volumes of Serratus Posterıor Superıor Intercostal Plane Block In Patıents Undergoıng Modıfıed Radıcal Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT07670078
- Acronym / sponsor ID
- 2026-06/47
- Keywords
- postoperative pain, regional anesthesia, Modified radical mastectomy, opioid free analgesia, facial plan block, serratus posterior superior intercostal plane block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 26 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.
The aim of researchers is to compare the effects of three different local anesthetic concentrations and volumes on opioid consumption, postoperative analgesic efficacy, and pain scores during ultrasound-guided SPSIP blocks in patients undergoing modified radical mastectomy. Additionally, we aim to map and identify the dermatomal areas where different concentrations and volumes of SPSIP blocks provide analgesia.
Detailed description
The researchers' hypothesis is that a lower concentration but higher volume of SPSIP block could provide similar analgesic efficacy to a higher concentration and lower volume block, while also improving the safety profile in terms of local anesthetic systemic toxicity by reducing the total local anesthetic load. In other words, we believe that using less than the 0.25% bupivacaine used in previous studies on this block could provide similar analgesic efficacy. This is because, in fascial plane blocks, separating the fascia is as important a technique as the local anesthetic administered. Facial plane blocks are volume-dependent blocks.
The Modified Aldrete scoring system is a routine assessment performed in our clinic's postoperative recovery room to determine whether a patient has recovered. Patients with an NRS score of 4 or higher, despite routine analgesia, will receive 50 mg tramadol hydrochloride as a rescue analgesic, administered intravenously over 30 minutes in 150 ml of saline solution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 ml of 0.25% Bupivacaine | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaineA Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution). |
| 40 ml of 0.1875% Bupivacaine | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaineA Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.1875% bupivacaine (15 ml of the drug + 25 ml of isotonic solution). |
| 50 ml of 0.15% bupivacaine | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaineA Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.15% bupivacaine (15 ml of the drug + 35 ml of isotonic solution). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study included adult patients over 18 years of age who underwent modified radical mastectomy under general anesthesia and were classified in risk groups I-II-III according to the American Society of Anesthesiologists (ASA) risk classification.
Key exclusion criteria (11 listed)
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients with ASA IV
- patients with known allergies to any of the study drugs,
- patients with ineffective block
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 |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaineA Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.1875% bupivacaine (15 ml of the drug + 25 ml of isotonic solution). | Procedure or surgery | 40 ml of 0.1875% Bupivacaine |
| Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaineA Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.15% bupivacaine (15 ml of the drug + 35 ml of isotonic solution). | Procedure or surgery | 50 ml of 0.15% bupivacaine |
| Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaineA Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution). | Procedure or surgery | 30 ml of 0.25% Bupivacaine |
Primary outcome
Total tramadol consumption
Time frame: Postoperative 24 hours
Postoperative total analgesic need was recorded as "milligram" in unit.
2 secondary outcomes
Dermatome Area
Time frame: 30th minute after the block
Numeric Rating Scale (NRS) Scores
Time frame: Postoperative 24 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 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine and Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine in people with Modified Radical Mastectomy and Post Operative Pain, Acute, run by Cumhuriyet 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 1 inclusion and 11 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: opening soon, as of the sponsor's last update on 25 Aug 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 OĞUZ GÜNDOĞDU (+905545945469, oguzgundogdu@cumhuriyet.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total tramadol consumption (time frame: Postoperative 24 hours). 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 25 Aug 2026.