MastectomyNCT06789146
Comparison of the Postoperative Analgesic Effects of SPSIPB and TPB in Mastectomy Operations
A study testing Serratus posterior superior intercostal plane block and Thoracic Paravertebral Block in people with Mastectomy and Peripheral Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common malignancy in women, and surgery is one of the cornerstone treatments for breast cancer. Postoperative pain can significantly reduce patients' quality of life and acute pain may even trigger chronic pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Mastectomy, Peripheral Nerve Block, Pain Management
- What is being tested?
- Serratus posterior superior intercostal plane block and Thoracic Paravertebral Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2025to 23 Feb 2026
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Who cannot join
- Patients under 18 and over 80 years of age
- ASA score IV and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: Comparison of the Postoperative Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block and Thoracic Paravertebral Block in Mastectomy Operations
Breast cancer is the most common malignancy in women, and surgery is one of the cornerstone treatments for breast cancer. Postoperative pain can significantly reduce patients' quality of life and acute pain may even trigger chronic pain syndrome.
Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.
In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and thoracic paravertebral block in the postoperative period in patients who underwent mastectomy.
- Conditions
- Mastectomy, Peripheral Nerve Block, Pain Management
- Being tested
- Serratus posterior superior intercostal plane block, Thoracic Paravertebral Block
- Keywords
- Mastectomy, Serratus Posterior Superior Intercostal Plane Block, Thoracic Paravertebral Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane blockProcedure or surgery
Serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance.
Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
Thoracic Paravertebral BlockProcedure or surgery
Thoracic paravertebral block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance.
Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Serratus posterior superior intercostal plane block | Active comparator | After the patients are monitored and in the supine position, after appropriate field sterilization, a serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. Receives: Procedure: Serratus posterior superior intercostal plane block |
| Thoracic Paravertebral Block | Active comparator | After the patients are monitored and in the supine position, after appropriate field sterilization, a thoracic paravertebral block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. Receives: Procedure: Thoracic Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
Measured: On the operation day
Secondary outcomes (2)
Intraoperative opioid consumption
Remifentanil consumption for intraoperative period will be recorded
Measured: Intraoperative period
Postoperative Tramadol Consumption
Tramadol consumption for 24 hours will be recorded
Measured: On the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start12 Feb 2025
- Primary completion2 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789146
- Sponsor's protocol ID
- AEŞH-EK-2025-07
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block and Thoracic Paravertebral Block in Mastectomy Operations
- ClinicalTrials.gov ID
- NCT06789146
- Acronym / sponsor ID
- AEŞH-EK-2025-07
- Conditions
- Mastectomy, Peripheral Nerve Block, Pain Management
- Keywords
- Mastectomy, Serratus Posterior Superior Intercostal Plane Block, Thoracic Paravertebral Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 23 Jan 2025 (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.
Breast cancer is the most common malignancy in women, and surgery is one of the cornerstone treatments for breast cancer. Postoperative pain can significantly reduce patients' quality of life and acute pain may even trigger chronic pain syndrome.
Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.
In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and thoracic paravertebral block in the postoperative period in patients who underwent mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus posterior superior intercostal plane block | Active comparator | Procedure: Serratus posterior superior intercostal plane blockAfter the patients are monitored and in the supine position, after appropriate field sterilization, a serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. |
| Thoracic Paravertebral Block | Active comparator | Procedure: Thoracic Paravertebral BlockAfter the patients are monitored and in the supine position, after appropriate field sterilization, a thoracic paravertebral block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Key exclusion criteria (4 listed)
- Patients under 18 and over 80 years of age
- ASA score IV and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
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 blockSerratus posterior superior intercostal plane block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. | Procedure or surgery | Serratus posterior superior intercostal plane block |
| Thoracic Paravertebral BlockThoracic paravertebral block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. | Procedure or surgery | Thoracic Paravertebral Block |
Primary outcome
Pain Scores
Time frame: On the operation day
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
2 secondary outcomes
Intraoperative opioid consumption
Time frame: Intraoperative period
Postoperative Tramadol Consumption
Time frame: On the operation day
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 24 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 block and Thoracic Paravertebral Block in people with Mastectomy and Peripheral Nerve Block, run by Ankara Etlik City Hospital 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 3 inclusion and 4 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 24 Feb 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?
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?
Pain Scores (time frame: On the operation day). 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 Feb 2026.