Breast Cancer Surgery Painbreast surgeryNCT07601490
The Effect of Nerve Blocks on Analgesia in Breast Cancer Surgery
A study testing Serratus Posterior Superior Intercostal Plane Block and Serratus anterior plane block (SAP) in people with Breast Cancer Surgery Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain following modified radical mastectomy remains a significant clinical concern and may adversely affect patient recovery, opioid consumption, and overall patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Surgery Pain
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block and Serratus anterior plane block (SAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 16 Oct 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body Mass Index (BMI) <35 kg/m²
- Normal International Normalized Ratio (INR) value and platelet count
- Normal liver and renal function tests
- Patients scheduled for elective modified radical mastectomy surgery
Who cannot join
- Bleeding diathesis
- Allergy to local anesthetic agents
- Suspected infection or inflammation at the planned block site
- ASA physical status IV or higher
- Long-term medication use due to chronic pain
- Advanced hepatic or renal failure
Show all 10Show fewer
- Presence of severe pulmonary disease
- Use of any opioid medication within 24 hours before surgery
- Cognitive impairment
- Patients undergoing revision surgery
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
Health Sciences University 2. Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Uskudar, 34668
Dilek Metin Yamac, Medicine Doctor, +90216 542 20 00, ddilekmetin@hotmail.com
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Modified Radical Mastectomy Surgery
Postoperative pain following modified radical mastectomy remains a significant clinical concern and may adversely affect patient recovery, opioid consumption, and overall patient satisfaction. Ultrasound-guided regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies in breast surgery. The serratus anterior plane (SAP) block is a commonly used interfascial plane block for postoperative analgesia in thoracic and breast procedures. Recently, the serratus posterior superior intercostal plane (SPSIP) block has emerged as a novel regional anesthesia technique with potentially wider thoracic dermatomal spread and effective analgesic properties.
This prospective randomized controlled study aims to compare the postoperative analgesic efficacy of the SPSIP block and SAP block in patients undergoing modified radical mastectomy under general anesthesia. Patients will be randomly allocated into two groups to receive either ultrasound-guided SPSIP block or SAP block preoperatively. Primary outcomes will include postoperative pain scores and opioid consumption within the first 24 hours after surgery. Secondary outcomes will include time to first analgesic request, rescue analgesic requirements, intraoperative hemodynamic parameters, postoperative nausea and vomiting, block-related complications, and patient satisfaction.
The study is designed to evaluate whether SPSIP block provides superior postoperative analgesia compared with SAP block in modified radical mastectomy surgery.
Read the detailed description
This prospective, randomized, controlled clinical study is designed to compare the postoperative analgesic efficacy of the ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block and Serratus Anterior Plane (SAP) block in patients undergoing modified radical mastectomy under general anesthesia. Postoperative pain after breast cancer surgery remains an important clinical problem and may negatively affect respiratory function, early mobilization, recovery quality, patient satisfaction, and postoperative opioid consumption. Effective perioperative analgesia is therefore an essential component of enhanced recovery protocols in breast surgery.
Regional anesthesia techniques have increasingly been incorporated into multimodal analgesia strategies to reduce opioid-related adverse effects and improve postoperative pain control. The SAP block is widely used in breast and thoracic surgery due to its ability to provide analgesia to the lateral thoracic wall through blockade of the lateral cutaneous branches of the intercostal nerves. However, recently described fascial plane blocks such as the SPSIP block may provide broader dermatomal spread and more effective thoracic analgesia. Despite growing interest in the SPSIP block, evidence regarding its analgesic efficacy in breast surgery remains limited.
The study will include adult female patients scheduled for elective modified radical mastectomy under general anesthesia. Following enrollment and randomization, patients will be allocated to receive either ultrasound-guided SPSIP block or SAP block preoperatively in addition to standardized general anesthesia and multimodal analgesia protocols. All regional blocks will be performed under sterile conditions using ultrasound guidance by experienced anesthesiologists. Standard intraoperative monitoring will be applied throughout the surgical procedure.
Perioperative anesthetic management will be standardized as much as possible to minimize confounding factors affecting postoperative pain outcomes. Intraoperative opioid administration, hemodynamic parameters, and anesthetic requirements will be recorded. Postoperative analgesia protocols, including rescue analgesic administration criteria, will also be standardized for all participants.
The primary aim of the study is to evaluate and compare postoperative analgesic effectiveness between SPSIP and SAP blocks. Analgesic efficacy will be assessed using postoperative pain scores at predefined time intervals and cumulative opioid consumption during the postoperative period. Additional perioperative parameters related to recovery and analgesic quality will also be evaluated to determine the clinical utility of these interfascial plane blocks in breast surgery.
This study is expected to contribute to the current literature regarding novel regional anesthesia techniques for breast surgery and may help define the role of SPSIP block as an alternative or superior analgesic approach compared with SAP block in modified radical mastectomy patients.
- Conditions
- Breast Cancer Surgery Pain
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, Serratus anterior plane block (SAP)
- Keywords
- modified radical mastectomy, Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block, Postoperative analgesia
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
Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
Serratus anterior plane block (SAP)Procedure or surgery
Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane (SPSIP) block | Experimental | Participants assigned to this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| Serratus Anterior Plane (SAP) block | Active comparator | Participants assigned to this group will receive an ultrasound-guided Serratus Anterior Plane (SAP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated. Receives: Procedure: Serratus anterior plane block (SAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain." VAS scores at rest and during movement will be recorded and compared between patients receiving ultrasound-guided superior posterior serratus intercostal plane (SPSIP) block and serratus anterior plane (SAP) block following modified radical mastectomy surgery. Higher VAS scores indicate greater pain severity and poorer analgesic efficacy.
Measured: At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
Secondary outcomes (3)
Intraoperative remifentanil consumption
Total intraoperative remifentanil consumption will be recorded and compared between the SPSIP block group and SAP block group.
Measured: During surgery
Total postoperative tramadol consumption within 24 hours
Total tramadol consumption during the first 24 postoperative hours will be recorded to evaluate postoperative opioid requirements in both groups.
Measured: First 24 hours after surgery
Postoperative nausea and vomiting (PONV) scores
Postoperative nausea and vomiting will be assessed using a standardized Postoperative Nausea and Vomiting (PONV) severity scale ranging from 0 to 3, where 0 indicates no nausea or vomiting, 1 indicates mild nausea, 2 indicates severe nausea or a single episode of vomiting, and 3 indicates multiple episodes of vomiting. PONV scores will be recorded and compared between groups during the postoperative period. Higher scores indicate more severe postoperative nausea and vomiting and therefore worse clinical outcomes.
Measured: First 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 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion16 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Surgery 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 scheduled for elective modified radical mastectomy will be randomly assigned in a parallel-group design to receive either ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block or Serratus Anterior Plane (SAP) block prior to induction of general anesthesia. Randomization will be performed using a computer-generated allocation sequence. Both groups will receive standardized general anesthesia and postoperative multimodal analgesia protocols to minimize confounding variables. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be compared between groups. Outcome assessments will be conducted at predefined postoperative time intervals by investigators blinded to group allocation whenever feasible. The study is designed to evaluate the comparative analgesic efficacy and safety profile of the two regional anesthesia techniques in breast surgery patients.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yamac, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601490
- Sponsor's protocol ID
- SBU-ANESTEZİ-DMY-05
- Acronym
- breast surgery
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y.
PubMed 41318393Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.
PubMed 36107549
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Modified Radical Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT07601490
- Acronym / sponsor ID
- breast surgery / SBU-ANESTEZİ-DMY-05
- Conditions
- Breast Cancer Surgery Pain
- Keywords
- modified radical mastectomy, Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 22 May 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.
Postoperative pain following modified radical mastectomy remains a significant clinical concern and may adversely affect patient recovery, opioid consumption, and overall patient satisfaction. Ultrasound-guided regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies in breast surgery. The serratus anterior plane (SAP) block is a commonly used interfascial plane block for postoperative analgesia in thoracic and breast procedures. Recently, the serratus posterior superior intercostal plane (SPSIP) block has emerged as a novel regional anesthesia technique with potentially wider thoracic dermatomal spread and effective analgesic properties.
This prospective randomized controlled study aims to compare the postoperative analgesic efficacy of the SPSIP block and SAP block in patients undergoing modified radical mastectomy under general anesthesia. Patients will be randomly allocated into two groups to receive either ultrasound-guided SPSIP block or SAP block preoperatively. Primary outcomes will include postoperative pain scores and opioid consumption within the first 24 hours after surgery. Secondary outcomes will include time to first analgesic request, rescue analgesic requirements, intraoperative hemodynamic parameters, postoperative nausea and vomiting, block-related complications, and patient satisfaction.
The study is designed to evaluate whether SPSIP block provides superior postoperative analgesia compared with SAP block in modified radical mastectomy surgery.
Detailed description
This prospective, randomized, controlled clinical study is designed to compare the postoperative analgesic efficacy of the ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block and Serratus Anterior Plane (SAP) block in patients undergoing modified radical mastectomy under general anesthesia. Postoperative pain after breast cancer surgery remains an important clinical problem and may negatively affect respiratory function, early mobilization, recovery quality, patient satisfaction, and postoperative opioid consumption. Effective perioperative analgesia is therefore an essential component of enhanced recovery protocols in breast surgery.
Regional anesthesia techniques have increasingly been incorporated into multimodal analgesia strategies to reduce opioid-related adverse effects and improve postoperative pain control. The SAP block is widely used in breast and thoracic surgery due to its ability to provide analgesia to the lateral thoracic wall through blockade of the lateral cutaneous branches of the intercostal nerves. However, recently described fascial plane blocks such as the SPSIP block may provide broader dermatomal spread and more effective thoracic analgesia. Despite growing interest in the SPSIP block, evidence regarding its analgesic efficacy in breast surgery remains limited.
The study will include adult female patients scheduled for elective modified radical mastectomy under general anesthesia. Following enrollment and randomization, patients will be allocated to receive either ultrasound-guided SPSIP block or SAP block preoperatively in addition to standardized general anesthesia and multimodal analgesia protocols. All regional blocks will be performed under sterile conditions using ultrasound guidance by experienced anesthesiologists. Standard intraoperative monitoring will be applied throughout the surgical procedure.
Perioperative anesthetic management will be standardized as much as possible to minimize confounding factors affecting postoperative pain outcomes. Intraoperative opioid administration, hemodynamic parameters, and anesthetic requirements will be recorded. Postoperative analgesia protocols, including rescue analgesic administration criteria, will also be standardized for all participants.
The primary aim of the study is to evaluate and compare postoperative analgesic effectiveness between SPSIP and SAP blocks. Analgesic efficacy will be assessed using postoperative pain scores at predefined time intervals and cumulative opioid consumption during the postoperative period. Additional perioperative parameters related to recovery and analgesic quality will also be evaluated to determine the clinical utility of these interfascial plane blocks in breast surgery.
This study is expected to contribute to the current literature regarding novel regional anesthesia techniques for breast surgery and may help define the role of SPSIP block as an alternative or superior analgesic approach compared with SAP block in modified radical mastectomy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants scheduled for elective modified radical mastectomy will be randomly assigned in a parallel-group design to receive either ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block or Serratus Anterior Plane (SAP) block prior to induction of general anesthesia. Randomization will be performed using a computer-generated allocation sequence. Both groups will receive standardized general anesthesia and postoperative multimodal analgesia protocols to minimize confounding variables. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be compared between groups. Outcome assessments will be conducted at predefined postoperative time intervals by investigators blinded to group allocation whenever feasible. The study is designed to evaluate the comparative analgesic efficacy and safety profile of the two regional anesthesia techniques in breast surgery patients.
| Arm | Type | Receives |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane (SPSIP) block | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants assigned to this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated. |
| Serratus Anterior Plane (SAP) block | Active comparator | Procedure: Serratus anterior plane block (SAP)Participants assigned to this group will receive an ultrasound-guided Serratus Anterior Plane (SAP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body Mass Index (BMI) <35 kg/m²
- Normal International Normalized Ratio (INR) value and platelet count
- Normal liver and renal function tests
Key exclusion criteria (10 listed)
- Bleeding diathesis
- Allergy to local anesthetic agents
- Suspected infection or inflammation at the planned block site
- ASA physical status IV or higher
- Long-term medication use due to chronic pain
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 BlockUltrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane (SPSIP) block |
| Serratus anterior plane block (SAP)Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery. | Procedure or surgery | Serratus Anterior Plane (SAP) block |
Primary outcome
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Time frame: At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain." VAS scores at rest and during movement will be recorded and compared between patients receiving ultrasound-guided superior posterior serratus intercostal plane (SPSIP) block and serratus anterior plane (SAP) block following modified radical mastectomy surgery. Higher VAS scores indicate greater pain severity and poorer analgesic efficacy.
3 secondary outcomes
Intraoperative remifentanil consumption
Time frame: During surgery
Total postoperative tramadol consumption within 24 hours
Time frame: First 24 hours after surgery
Postoperative nausea and vomiting (PONV) scores
Time frame: First 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 27 May 2026.
- Results publication: PubMed 41318393Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y.
- Results publication: PubMed 36107549Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.
- 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.
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 Serratus anterior plane block (SAP) in people with Breast Cancer Surgery Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 6 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: opening soon, as of the sponsor's last update on 27 May 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 Dilek Metin Yamac, MD (+905054959792, ddilekmetin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity assessed by Visual Analog Scale (VAS) (time frame: At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery). 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 NCT07601490, which also lists 2 linked publications.
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 27 May 2026.