Postoperative Pain Breast ReductionSPSIP-RMNCT07657949
SPSIP Block for Pain Control After Breast Reduction Surgery
A study testing Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block and Standard Perioperative Pain Treatment in people with Postoperative Pain Breast Reduction and Mammaplasty, run by Cumhuriyet University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain Breast Reduction, Mammaplasty, Analgesia
- What is being tested?
- Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block and Standard Perioperative Pain Treatment
- 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
- 24 Aug 2026to 30 Sep 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
- Female participants aged 18 to 65 years
- Scheduled for elective bilateral reduction mammaplasty
- Planned surgery under general anesthesia
- American Society of Anesthesiologists physical status class I to III
- Planned postoperative clinical follow-up for the first 24 hours after surgery
- Able to understand and report pain using the 0 to 10 Numeric Rating Scale
- Able to provide written informed consent for study participation
Who cannot join
- Known allergy or hypersensitivity to local anesthetic drugs
- Contraindication to regional anesthesia or fascial plane block
- Coagulopathy or clinically significant bleeding disorder
- Use of anticoagulant or antiplatelet medication that prevents safe block application
- Infection at the planned block injection site
- Chronic opioid use, chronic pain syndrome, or regular analgesic use that may affect postoperative pain assessment
Show all 10Show fewer
- Revision breast surgery
- Planned major additional surgical procedure other than reduction mammaplasty
- Pregnancy or lactation
- Unable to reliably report pain scores
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
Sivas Cumhuriyet University
Sivas, Sivas, 58050
Murat Çelik, 05546902104, mucetr@gmail.com
Onur Avcı, Associate Professor, 90 530 112 64 08, dronuravci@gmail.com
About this study
Official title: Effect of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block on Opioid Consumption After Reduction Mammaplasty: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery.
The main question it aims to answer is: Does adding an SPSIP block to standard anesthesia and pain treatment lower opioid use during the first 24 hours after surgery? Researchers will compare participants who receive standard anesthesia and pain treatment with participants who receive standard anesthesia and pain treatment plus an SPSIP block.
Read more
Participants will:
- Have planned bilateral breast reduction surgery under general anesthesia
- Be randomly assigned to the SPSIP block group or the control group
- Receive standard local anesthetic infiltration during surgery and standard pain treatment after surgery
- Have their pain score and pain medicine use recorded during the first 24 hours after surgery
- Be followed for safety and complications for 30 days after surgery
Read the detailed description
Reduction mammaplasty, also known as breast reduction surgery, may be associated with early postoperative pain because it is usually performed bilaterally and involves wide surgical dissection and tissue resection. Multimodal pain treatment is commonly used after this procedure to provide adequate pain control and to limit opioid exposure.
The serratus posterior superior intercostal plane block (SPSIP block) is an ultrasound-guided fascial plane block used for thoracic wall analgesia. Recent studies have evaluated this block in breast surgery, but data specific to reduction mammaplasty remain limited. In routine practice, surgical local anesthetic infiltration is often used during reduction mammaplasty. Therefore, this trial will evaluate whether adding bilateral SPSIP block to standard anesthesia, surgical local infiltration, and standard postoperative pain treatment provides additional opioid-sparing benefit.
This study is designed as a prospective, randomized, parallel-group, assessor-blinded, single-center clinical trial. Participants scheduled for elective bilateral reduction mammaplasty will be assigned in a 1:1 ratio to either the SPSIP block group or the control group. In the SPSIP block group, bilateral SPSIP block will be performed under ultrasound guidance after induction of general anesthesia and before surgical local infiltration and skin incision. The control group will not receive SPSIP block.
Both groups will receive the same standardized general anesthesia, surgical local anesthetic infiltration, postoperative multimodal analgesia, and rescue analgesia protocol. The local anesthetic agent, concentration, volume, and maximum safe dose limits for the block and surgical infiltration will be standardized before study enrollment.
The trial is planned to reflect routine plastic surgery practice. Surgical technique, pedicle selection, resection amount, drain use, and the use of dermal graft or internal support when clinically needed will be decided by the surgical team according to participant anatomy and routine clinical judgment. These variables will be recorded to describe surgical variability and may be considered in additional analyses if needed.
Postoperative pain assessments will be performed by ward nurses who are blinded to group allocation. Opioid use will be obtained from medication administration records. Block-related events and surgical complications will be recorded during routine postoperative care and up to 30 days after surgery.
- Conditions
- Postoperative Pain Breast Reduction, Mammaplasty, Analgesia, Nerve Block, Opioid Consumption, Postoperative
- Being tested
- Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block, Standard Perioperative Pain Treatment
- Keywords
- Serratus posterior superior intercostal plane block, Ultrasound-guided regional anesthesia, Reduction mammaplasty, Breast reduction surgery, Postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Also called SPSIP block
Bilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed after induction of general anesthesia and before surgical local anesthetic infiltration and skin incision.
Standard Perioperative Pain TreatmentOther
Also called Standard anesthesia and postoperative analgesia
Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
| Study group | Role | What they receive |
|---|---|---|
| SPSIP Block Group | Experimental | Participants in this arm will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block after induction of general anesthesia and before surgical local infiltration and skin incision. They will also receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment. Receives: Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block; Other: Standard Perioperative Pain Treatment |
| Control Group | Active comparator | Participants in this arm will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment. They will not receive serratus posterior superior intercostal plane block. Receives: Other: Standard Perioperative Pain Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption During the First 24 Hours After Surgery
Total opioid consumption will be calculated from all rescue opioid analgesics administered during the first 24 hours after surgery. Opioid use will be obtained from medication administration records and reported as intravenous morphine equivalent dose in milligrams. Higher values indicate greater opioid consumption.
Measured: From the end of surgery to 24 hours after surgery
Secondary outcomes (3)
Resting Pain Score at 6 Hours After Surgery
Pain intensity at rest will be assessed using the 0 to 10 Numeric Rating Scale. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Measured: 6 hours after surgery
Time to First Rescue Analgesic Requirement
The time from the end of surgery to the first administration of rescue analgesic medication will be recorded. Longer time indicates longer duration before additional analgesic treatment is needed.
Measured: From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours
The number of participants who develop postoperative nausea, vomiting, or require additional antiemetic medication during the first 24 hours after surgery will be recorded. This outcome will be assessed as present or absent for each participant.
Measured: From the end of surgery to 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 posted18 Jun 2026
- Study start24 Aug 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Breast ReductionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to two parallel groups: the SPSIP block group and the control group. The SPSIP block group will receive bilateral ultrasound-guided SPSIP block in addition to standard anesthesia and postoperative pain treatment. The control group will receive standard anesthesia and postoperative pain treatment without SPSIP block.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Çelik, Cumhuriyet University Hospital
- Investigators
- Handan Derebaşınlıoğlu, Associate Professor, Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657949
- Sponsor's protocol ID
- 26_06_04_35
- Acronym
- SPSIP-RM
- Status last verified
- Aug 2026
- First submitted
- 14 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: Individual participant data will not be shared because the study data contain clinical and perioperative information from surgical participants and sharing individual-level data was not included in the ethics approval or informed consent process.
Publications
Gundogdu O, Avci O, Balci F, Tekcan MN, Kol YC. Efficacy of Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: An Evidence Based Report. J Coll Physicians Surg Pak. 2024 Mar;34(3):348-350. doi: 10.29271/jcpsp.2024.03.348.
PubMed 38462873Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
PubMed 36883093Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18.
PubMed 31741068Singh NP, Makkar JK, Kuberan A, Guffey R, Uppal V. Efficacy of regional anesthesia techniques for postoperative analgesia in patients undergoing major oncologic breast surgeries: a systematic review and network meta-analysis of randomized controlled trials. Can J Anaesth. 2022 Apr;69(4):527-549. doi: 10.1007/s12630-021-02183-z. Epub 2022 Jan 31.
PubMed 35102494Chadbourne EB, Zhang S, Gordon MJ, Ro EY, Ross SD, Schnur PL, Schneider-Redden PR. Clinical outcomes in reduction mammaplasty: a systematic review and meta-analysis of published studies. Mayo Clin Proc. 2001 May;76(5):503-10. doi: 10.4065/76.5.503.
PubMed 11357797
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
- Effect of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block on Opioid Consumption After Reduction Mammaplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07657949
- Acronym / sponsor ID
- SPSIP-RM / 26_06_04_35
- Conditions
- Postoperative Pain Breast Reduction, Mammaplasty, Analgesia, Nerve Block, Opioid Consumption, Postoperative
- Keywords
- Serratus posterior superior intercostal plane block, Ultrasound-guided regional anesthesia, Reduction mammaplasty, Breast reduction surgery, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cumhuriyet University HospitalUniversity, hospital or other
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 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 goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery.
The main question it aims to answer is: Does adding an SPSIP block to standard anesthesia and pain treatment lower opioid use during the first 24 hours after surgery? Researchers will compare participants who receive standard anesthesia and pain treatment with participants who receive standard anesthesia and pain treatment plus an SPSIP block.
Participants will:
- Have planned bilateral breast reduction surgery under general anesthesia
- Be randomly assigned to the SPSIP block group or the control group
- Receive standard local anesthetic infiltration during surgery and standard pain treatment after surgery
- Have their pain score and pain medicine use recorded during the first 24 hours after surgery
- Be followed for safety and complications for 30 days after surgery
Detailed description
Reduction mammaplasty, also known as breast reduction surgery, may be associated with early postoperative pain because it is usually performed bilaterally and involves wide surgical dissection and tissue resection. Multimodal pain treatment is commonly used after this procedure to provide adequate pain control and to limit opioid exposure.
The serratus posterior superior intercostal plane block (SPSIP block) is an ultrasound-guided fascial plane block used for thoracic wall analgesia. Recent studies have evaluated this block in breast surgery, but data specific to reduction mammaplasty remain limited. In routine practice, surgical local anesthetic infiltration is often used during reduction mammaplasty. Therefore, this trial will evaluate whether adding bilateral SPSIP block to standard anesthesia, surgical local infiltration, and standard postoperative pain treatment provides additional opioid-sparing benefit.
This study is designed as a prospective, randomized, parallel-group, assessor-blinded, single-center clinical trial. Participants scheduled for elective bilateral reduction mammaplasty will be assigned in a 1:1 ratio to either the SPSIP block group or the control group. In the SPSIP block group, bilateral SPSIP block will be performed under ultrasound guidance after induction of general anesthesia and before surgical local infiltration and skin incision. The control group will not receive SPSIP block.
Both groups will receive the same standardized general anesthesia, surgical local anesthetic infiltration, postoperative multimodal analgesia, and rescue analgesia protocol. The local anesthetic agent, concentration, volume, and maximum safe dose limits for the block and surgical infiltration will be standardized before study enrollment.
The trial is planned to reflect routine plastic surgery practice. Surgical technique, pedicle selection, resection amount, drain use, and the use of dermal graft or internal support when clinically needed will be decided by the surgical team according to participant anatomy and routine clinical judgment. These variables will be recorded to describe surgical variability and may be considered in additional analyses if needed.
Postoperative pain assessments will be performed by ward nurses who are blinded to group allocation. Opioid use will be obtained from medication administration records. Block-related events and surgical complications will be recorded during routine postoperative care and up to 30 days after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to two parallel groups: the SPSIP block group and the control group. The SPSIP block group will receive bilateral ultrasound-guided SPSIP block in addition to standard anesthesia and postoperative pain treatment. The control group will receive standard anesthesia and postoperative pain treatment without SPSIP block.
| Arm | Type | Receives |
|---|---|---|
| SPSIP Block Group | Experimental | Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block, Other: Standard Perioperative Pain TreatmentParticipants in this arm will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block after induction of general anesthesia and before surgical local infiltration and skin incision. They will also receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment. |
| Control Group | Active comparator | Other: Standard Perioperative Pain TreatmentParticipants in this arm will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment. They will not receive serratus posterior superior intercostal plane block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female participants aged 18 to 65 years
- Scheduled for elective bilateral reduction mammaplasty
- Planned surgery under general anesthesia
- American Society of Anesthesiologists physical status class I to III
- Planned postoperative clinical follow-up for the first 24 hours after surgery
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to local anesthetic drugs
- Contraindication to regional anesthesia or fascial plane block
- Coagulopathy or clinically significant bleeding disorder
- Use of anticoagulant or antiplatelet medication that prevents safe block application
- Infection at the planned block injection site
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 |
|---|---|---|
| Ultrasound-Guided Serratus Posterior Superior Intercostal Plane BlockAlso: SPSIP blockBilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed after induction of general anesthesia and before surgical local anesthetic infiltration and skin incision. | Procedure or surgery | SPSIP Block Group |
| Standard Perioperative Pain TreatmentAlso: Standard anesthesia and postoperative analgesiaParticipants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed. | Other | Control Group, SPSIP Block Group |
Primary outcome
Total Opioid Consumption During the First 24 Hours After Surgery
Time frame: From the end of surgery to 24 hours after surgery
Total opioid consumption will be calculated from all rescue opioid analgesics administered during the first 24 hours after surgery. Opioid use will be obtained from medication administration records and reported as intravenous morphine equivalent dose in milligrams. Higher values indicate greater opioid consumption.
3 secondary outcomes
Resting Pain Score at 6 Hours After Surgery
Time frame: 6 hours after surgery
Time to First Rescue Analgesic Requirement
Time frame: From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours
Time frame: From the end of surgery to 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 25 Aug 2026.
- Background: PubMed 38462873Gundogdu O, Avci O, Balci F, Tekcan MN, Kol YC. Efficacy of Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: An Evidence Based Report. J Coll Physicians Surg Pak. 2024 Mar;34(3):348-350. doi: 10.29271/jcpsp.2024.03.348.
- Background: PubMed 36883093Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Background: PubMed 31741068Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18.
- Background: PubMed 35102494Singh NP, Makkar JK, Kuberan A, Guffey R, Uppal V. Efficacy of regional anesthesia techniques for postoperative analgesia in patients undergoing major oncologic breast surgeries: a systematic review and network meta-analysis of randomized controlled trials. Can J Anaesth. 2022 Apr;69(4):527-549. doi: 10.1007/s12630-021-02183-z. Epub 2022 Jan 31.
- Background: PubMed 11357797Chadbourne EB, Zhang S, Gordon MJ, Ro EY, Ross SD, Schnur PL, Schneider-Redden PR. Clinical outcomes in reduction mammaplasty: a systematic review and meta-analysis of published studies. Mayo Clin Proc. 2001 May;76(5):503-10. doi: 10.4065/76.5.503.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study data contain clinical and perioperative information from surgical participants and sharing individual-level data was not included in the ethics approval or informed consent process.
Related trials for Postoperative Pain Breast Reduction
Active, not recruiting
Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Breast Reduction Surgery
Postoperative Analgesia in Breast Reduction Surgery, Postoperative Pain
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.
Handan Derebaşınlıoğlu, Associate Professor study director
Cumhuriyet 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 Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block and Standard Perioperative Pain Treatment in people with Postoperative Pain Breast Reduction and Mammaplasty, run by Cumhuriyet University 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 7 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 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 Murat Çelik, Assistant Professor (+905546902104, mucetr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption During the First 24 Hours After Surgery (time frame: From the end of surgery to 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 NCT07657949, which also lists 5 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 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.