Shoulder PainNCT07278050
Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block
A study testing Erector spinae plane block, Serratus posterior superior intercostal plane block and Postoperative analgesia management in people with Shoulder Pain and Shoulder Disease, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and a shorter hospital stay. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are usually performed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain, Shoulder Disease
- What is being tested?
- Erector spinae plane block, Serratus posterior superior intercostal plane block and Postoperative analgesia management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2026to 25 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Who cannot join
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who do not accept the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yunus Atalay, Prof, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
Bahadir Ciftci, MD, +905325034428, bciftci@medipol.edu.tr
About this study
Official title: Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia Management After Arthroscopic Shoulder Surgery: A Randomized Prospective Study
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and a shorter hospital stay. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are usually performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.
Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after shoulder surgery.
The aim of this study is to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.
Read the detailed description
Postoperative pain is an important issue in patients who have undergone arthroscopic shoulder surgery. Pain causes a few problems: uncomfortable patients, negative outcomes, and longer rehabilitation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization, such as infection and thromboembolism, may be reduced. Various techniques may be used for postoperative pain treatment. Opioids are one of the most preferred drugs among analgesic agents. Parenteral opioids are generally administered to patients after surgery. However, opioids have undesirable adverse events such as nausea, vomiting, itching, sedation, and respiratory depression (opioid-related adverse events).
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are commonly used. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.
US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided.
In the cadaveric study of Tulgar et al., it was determined that the spread of the serratus posterior superior interfacial plane block, 7-10 intercostal levels on the left side, only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region, such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of the SPSP block for postoperative analgesia management after shoulder surgery.
This study aims to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery. The primary aim is to compare postoperative opioid consumption (fentanyl), and the secondary aim is to evaluate postoperative pain scores (NRS), adverse effects related to opioids (allergic reaction, nausea, vomiting).
- Conditions
- Shoulder Pain, Shoulder Disease
- Being tested
- Erector spinae plane block, Serratus posterior superior intercostal plane block, Postoperative analgesia management
- Keywords
- Arthroscopic Shoulder Surgery, Postoperative analgesia management, serratus posterior superior intercostal plane block, Interscalene brachial plexus block
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockDrug
The procedure will be performed with the patient in the supine position after surgery before extubation. ESPB will be performed. The US probe will be placed longitudinally 2-3 cm lateral to the T2 transverse process. The erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted in a caudo-cranial direction, and then, for correction, 5 ml of saline will be injected deep into the erector spinae muscle fascia. Following confirmation of the correct position of the needle, 30 mL %0.25 bupivacaine will be administered for the block.
Serratus posterior superior intercostal plane blockDrug
A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the sitting position after surgery before extubation. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.
Postoperative analgesia managementDrug
Patients will be administered ibuprofen 400 mg IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including a 10 mcg bolus without an infusion dose, a 10-minute lockout time, and a 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 IV meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group SPSIPB = SPSIPB group | Active comparator | SPSIPB will be performed Receives: Drug: Serratus posterior superior intercostal plane block; Drug: Postoperative analgesia management |
| Group ESPB = ESPB group | Active comparator | ESPB will be performed Receives: Drug: Erector spinae plane block; Drug: Postoperative analgesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption (fentanyl)
The primary aim is to compare postoperative opioid consumption
Measured: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 hours
Secondary outcomes (3)
Pain scores (Numerical rating scores-NRS)
The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
Measured: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Measured: Postoperative 24 hours period
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start10 Jan 2026
- Primary completion20 Sep 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. The first group is the serratus posterior superior intercostal plane block group. The second one is an interscalene brachial plexus block.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278050
- Sponsor's protocol ID
- E-10840098-202.3.02-1405
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.
PubMed 38240640Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
PubMed 35550031Zhang Y, Li H, Xu S, Guo R, Ma D, Wang Y. Understanding the Anatomy of Posterior Cervical Interfascial Space: Implications for Regional Blocks and Pain Management. A Narrative Review. Pain Ther. 2025 Aug;14(4):1203-1222. doi: 10.1007/s40122-025-00754-2. Epub 2025 Jun 16.
PubMed 40522591Tulgar 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 36883093
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia Management After Arthroscopic Shoulder Surgery: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07278050
- Acronym / sponsor ID
- E-10840098-202.3.02-1405
- Conditions
- Shoulder Pain, Shoulder Disease
- Keywords
- Arthroscopic Shoulder Surgery, Postoperative analgesia management, serratus posterior superior intercostal plane block, Interscalene brachial plexus block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 11 Dec 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.
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and a shorter hospital stay. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are usually performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.
Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after shoulder surgery.
The aim of this study is to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.
Detailed description
Postoperative pain is an important issue in patients who have undergone arthroscopic shoulder surgery. Pain causes a few problems: uncomfortable patients, negative outcomes, and longer rehabilitation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization, such as infection and thromboembolism, may be reduced. Various techniques may be used for postoperative pain treatment. Opioids are one of the most preferred drugs among analgesic agents. Parenteral opioids are generally administered to patients after surgery. However, opioids have undesirable adverse events such as nausea, vomiting, itching, sedation, and respiratory depression (opioid-related adverse events).
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are commonly used. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.
US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided.
In the cadaveric study of Tulgar et al., it was determined that the spread of the serratus posterior superior interfacial plane block, 7-10 intercostal levels on the left side, only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region, such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of the SPSP block for postoperative analgesia management after shoulder surgery.
This study aims to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery. The primary aim is to compare postoperative opioid consumption (fentanyl), and the secondary aim is to evaluate postoperative pain scores (NRS), adverse effects related to opioids (allergic reaction, nausea, vomiting).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. The first group is the serratus posterior superior intercostal plane block group. The second one is an interscalene brachial plexus block.
| Arm | Type | Receives |
|---|---|---|
| Group SPSIPB = SPSIPB group | Active comparator | Drug: Serratus posterior superior intercostal plane block, Drug: Postoperative analgesia managementSPSIPB will be performed |
| Group ESPB = ESPB group | Active comparator | Drug: Erector spinae plane block, Drug: Postoperative analgesia managementESPB will be performed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Key exclusion criteria (6 listed)
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
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 |
|---|---|---|
| Erector spinae plane blockThe procedure will be performed with the patient in the supine position after surgery before extubation. ESPB will be performed. The US probe will be placed longitudinally 2-3 cm lateral to the T2 transverse process. The erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted in a caudo-cranial direction, and then, for correction, 5 ml of saline will be injected deep into the erector spinae muscle fascia. Following confirmation of the correct position of the needle, 30 mL %0.25 bupivacaine will be administered for the block. | Drug | Group ESPB = ESPB group |
| Serratus posterior superior intercostal plane blockA high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the sitting position after surgery before extubation. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used. | Drug | Group SPSIPB = SPSIPB group |
| Postoperative analgesia managementPatients will be administered ibuprofen 400 mg IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including a 10 mcg bolus without an infusion dose, a 10-minute lockout time, and a 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 IV meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure. | Drug | Group ESPB = ESPB group, Group SPSIPB = SPSIPB group |
Primary outcome
Opioid consumption (fentanyl)
Time frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 hours
The primary aim is to compare postoperative opioid consumption
3 secondary outcomes
Pain scores (Numerical rating scores-NRS)
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
Time frame: Postoperative 24 hours period
Adverse events
Time frame: Postoperative 24 hours period
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 14 Jan 2026.
- Background: PubMed 38240640Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.
- Background: PubMed 35550031Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
- Background: PubMed 40522591Zhang Y, Li H, Xu S, Guo R, Ma D, Wang Y. Understanding the Anatomy of Posterior Cervical Interfascial Space: Implications for Regional Blocks and Pain Management. A Narrative Review. Pain Ther. 2025 Aug;14(4):1203-1222. doi: 10.1007/s40122-025-00754-2. Epub 2025 Jun 16.
- 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.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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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.
Yunus Atalay, Prof, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block, Serratus posterior superior intercostal plane block and Postoperative analgesia management in people with Shoulder Pain and Shoulder Disease, run by Medipol 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 2 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: looking for participants now, as of the sponsor's last update on 14 Jan 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 Bahadir Ciftci, Assoc Prof, MD (+905343736865, bciftci@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (fentanyl) (time frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 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 NCT07278050, which also lists 4 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 14 Jan 2026.