MastectomyNCT06438211
Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks for Mastectomy
A study testing superficial or deep serratus anterior plane block for mastectomy in people with Mastectomy and Postoperative Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Mastectomy, Postoperative Pain, Analgesia
- What is being tested?
- superficial or deep serratus anterior plane block for mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2024to 25 May 2025
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who will undergo mastectomy surgery
- patients who agreed to participate in the study
- ASA I-II patients
Who cannot join
- Patients planned for bilateral breast surgery
- Patients who have had previous breast surgery
- Patients with existing neuropathic pain or receiving treatment for neuropathic pain
- Patients with psychiatric disorders
- Patients with opioid addiction
- Patients allergic to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks in Patients Undergoing Mastectomy
Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. It is known that by using regional techniques, the use of general anesthetics and opioids can be reduced and their harmful effects can be limited. In this study, it will be compared the analgesic effectiveness of superficial and deep serratus plane blocks in the postoperative acute and chronic periods.
Read the detailed description
Acute and chronic pain is a serious problem in patients undergoing breast surgery. Apart from the feeling of pain, it also causes psychological difficulties, increased hospital stays, delays or difficulties in mobilization, and so on. Due to all these reasons, postoperative pain control is very important.
Although opioids are the gold standard in the treatment of pain, their side effect profiles (sedation, respiratory depression, constipation, tolerance development, etc.) limit their use and different searches are on the agenda. There are studies showing that superficial and deep serratus plane blocks are effective in mastectomy operations. In this study, patients who underwent mastectomy these two blocks will be compared to see which one is superior and to investigate the differences that may occur in the acute and chronic periods.
After general anesthesia induction, a superficial serratus plane block will be performed on the first group of patients undergoing surgery by applying local anesthetic to the fascia between the serratus anterior and latissimus dorsi muscles at the level of the 4th and 5th ribs under ultrasound. then the patient will undergo surgical procedure. Likewise, for the second group of patients, after general anesthesia induction, a deep serratus plane block will be performed by applying local anesthetic between the rib and the serratus anterior muscle at the level of the 4th and 5th ribs, under ultrasound guidance, and the patient will be taken into surgery. Both groups of patients will be monitored for 24 hours after the operation with a patient-controlled analgesia device. Patients' pain scores, satisfaction scores, nausea and vomiting scores, and additional analgesic needs will be recorded 24 hours postoperatively.
- Conditions
- Mastectomy, Postoperative Pain, Analgesia
- Being tested
- superficial or deep serratus anterior plane block for mastectomy
- Keywords
- serratus anterior plane block, local anesthetic, regional anesthesia, postoperative analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial or deep serratus anterior plane block for mastectomyProcedure or surgery
group I: superficial SAP Block for postoperative analgesia for mastectomy group II: deep SAP Block for postoperative analgesia for mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Group I (superficial serratus anterior plane block) | Active comparator | Single-shot ultrasound (Esaote Mylab30) guided Superficial SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level (between the latissimus dorsi muscle and the serratus anterior muscle) was performed preoperatively to patients in the Superficial SAP group (Group I) Receives: Procedure: superficial or deep serratus anterior plane block for mastectomy |
| Group II (deep serratus anterior plane block) | Active comparator | Single- shot ultrasound (Esaote Mylab30) guided Deep SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level ( between the serratus anterior muscle and the ribs) was performed preoperatively to patients in the Deep SAP group (Group I) Receives: Procedure: superficial or deep serratus anterior plane block for mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption
How much morphine the patient consumed in the first 24 hours postoperatively with a patient-controlled anesthesia device
Measured: 24 hours
Secondary outcomes (1)
measuring pain scors
Determining patients' pain levels with a visual analog scale (VAS) between the scale of 1-10
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start24 Jun 2024
- Primary completion24 Feb 2025
- Study completion25 May 2025
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 MastectomyStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ulgey, TC Erciyes University
- Investigators
- Ayşe Ülgey, MD, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438211
- Sponsor's protocol ID
- 2024/58
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tasar A, Talih G, Sonmez E, Gok M, Ulgey A. Comparison of the analgesic efficacy of superficial and deep serratus anterior plane blocks in patients undergoing breast cancer surgery: a prospective randomized single blind study. BMC Anesthesiol. 2026 Jan 15;26(1):107. doi: 10.1186/s12871-026-03627-z.
PubMed 41540334
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks in Patients Undergoing Mastectomy
- ClinicalTrials.gov ID
- NCT06438211
- Acronym / sponsor ID
- 2024/58
- Conditions
- Mastectomy, Postoperative Pain, Analgesia
- Keywords
- serratus anterior plane block, local anesthetic, regional anesthesia, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 31 May 2024 (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.
Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. It is known that by using regional techniques, the use of general anesthetics and opioids can be reduced and their harmful effects can be limited. In this study, it will be compared the analgesic effectiveness of superficial and deep serratus plane blocks in the postoperative acute and chronic periods.
Detailed description
Acute and chronic pain is a serious problem in patients undergoing breast surgery. Apart from the feeling of pain, it also causes psychological difficulties, increased hospital stays, delays or difficulties in mobilization, and so on. Due to all these reasons, postoperative pain control is very important.
Although opioids are the gold standard in the treatment of pain, their side effect profiles (sedation, respiratory depression, constipation, tolerance development, etc.) limit their use and different searches are on the agenda. There are studies showing that superficial and deep serratus plane blocks are effective in mastectomy operations. In this study, patients who underwent mastectomy these two blocks will be compared to see which one is superior and to investigate the differences that may occur in the acute and chronic periods.
After general anesthesia induction, a superficial serratus plane block will be performed on the first group of patients undergoing surgery by applying local anesthetic to the fascia between the serratus anterior and latissimus dorsi muscles at the level of the 4th and 5th ribs under ultrasound. then the patient will undergo surgical procedure. Likewise, for the second group of patients, after general anesthesia induction, a deep serratus plane block will be performed by applying local anesthetic between the rib and the serratus anterior muscle at the level of the 4th and 5th ribs, under ultrasound guidance, and the patient will be taken into surgery. Both groups of patients will be monitored for 24 hours after the operation with a patient-controlled analgesia device. Patients' pain scores, satisfaction scores, nausea and vomiting scores, and additional analgesic needs will be recorded 24 hours postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (superficial serratus anterior plane block) | Active comparator | Procedure: superficial or deep serratus anterior plane block for mastectomySingle-shot ultrasound (Esaote Mylab30) guided Superficial SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level (between the latissimus dorsi muscle and the serratus anterior muscle) was performed preoperatively to patients in the Superficial SAP group (Group I) |
| Group II (deep serratus anterior plane block) | Active comparator | Procedure: superficial or deep serratus anterior plane block for mastectomySingle- shot ultrasound (Esaote Mylab30) guided Deep SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level ( between the serratus anterior muscle and the ribs) was performed preoperatively to patients in the Deep SAP group (Group I) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who will undergo mastectomy surgery
- patients who agreed to participate in the study
- ASA I-II patients
Key exclusion criteria (6 listed)
- Patients planned for bilateral breast surgery
- Patients who have had previous breast surgery
- Patients with existing neuropathic pain or receiving treatment for neuropathic pain
- Patients with psychiatric disorders
- Patients with opioid addiction
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 |
|---|---|---|
| superficial or deep serratus anterior plane block for mastectomygroup I: superficial SAP Block for postoperative analgesia for mastectomy group II: deep SAP Block for postoperative analgesia for mastectomy | Procedure or surgery | Group I (superficial serratus anterior plane block), Group II (deep serratus anterior plane block) |
Primary outcome
postoperative morphine consumption
Time frame: 24 hours
How much morphine the patient consumed in the first 24 hours postoperatively with a patient-controlled anesthesia device
1 secondary outcome
measuring pain scors
Time frame: 24 hours
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 12 Aug 2025.
- Derived from this study: PubMed 41540334Tasar A, Talih G, Sonmez E, Gok M, Ulgey A. Comparison of the analgesic efficacy of superficial and deep serratus anterior plane blocks in patients undergoing breast cancer surgery: a prospective randomized single blind study. BMC Anesthesiol. 2026 Jan 15;26(1):107. doi: 10.1186/s12871-026-03627-z.
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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.
Ayşe Ülgey, MD study director
TC Erciyes 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 superficial or deep serratus anterior plane block for mastectomy in people with Mastectomy and Postoperative Pain, run by TC Erciyes 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 3 inclusion and 6 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 12 Aug 2025. 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?
postoperative morphine consumption (time frame: 24 hours). 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 NCT06438211, 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 12 Aug 2025.