RATS SurgerySPRATSNCT06545409
Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy
A study testing Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine in people with RATS Surgery and Thymectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) for postoperative pain control, reducing opioid analgesic consumption, minimizing postoperative respiratory complications, and enhancing patient satisfaction (measured using the QoR-15 index) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RATS Surgery, Thymectomy, Locoregional Anesthesia
- What is being tested?
- Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to 15 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study.
Who cannot join
- Patients who refuse to participate in the study by not signing the informed consent;
- Patients with myasthenia gravis, severe obesity (BMI > 35), history of OSAS with or without CPAP;
- Patients belonging to ASA classes > 3, according to the system developed by the American Society of Anesthesiologists;
- Patients unable to understand the functioning of the NPR Scale or the PCA device that will be used for postoperative analgesia;
- Patients with allergies to analgesic and/or anesthetic drugs;
- Patients on anticoagulant therapy;
Show all 11Show fewer
- Patients with a history of chronic pain;
- Patients with an infection at the site where SPSIPB will be performed;
- Patients who have had previous thoracic surgery and/or thoracic trauma with rib fractures on the side of the surgery;
- Patients with chest deformities and/or neuromuscular diseases that interfere with normal ventilatory function.
- Additionally, patients whose surgery is intraoperatively converted to sternotomy thymectomy will be excluded post-hoc from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dania Nachira, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico A.Gemelli IRCCs
Rome, 00135
Giovanni Punzo, MD, 0039 0630153212, giovanni.punzo@policlinicogemelli.it
About this study
Official title: Use of Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thoracoscopic Surgery for Thymectomy: A Randomized Controlled Trial
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) for postoperative pain control, reducing opioid analgesic consumption, minimizing postoperative respiratory complications, and enhancing patient satisfaction (measured using the QoR-15 index) in patients undergoing robotic thymectomy, compared to patients who do not receive the block.
Read the detailed description
All patients enrolled in the study will receive the SPSIP Block under ultrasound guidance 15 minutes before entering the operating room. The SPSIP Block will be performed by the attending anesthetist (investigator 1), who will use a syringe pre-filled with 30 ml of a solution prepared in advance by another investigator (investigator 2). According to the randomization scheme, the solution in the syringe used for the SPSIP Block will contain either 0.25% bupivacaine for 50% of the cases (SPSIP group) or sterile saline solution (0.9% NaCl) for the remaining 50% of the cases (control group). Postoperatively, data collection will be managed by a third investigator (investigator 3). Neither the investigator 1, the patient, nor the investigator 3 will be informed of the syringe's contents, ensuring the study is conducted blind.
All patients enrolled in the study will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of the surgery, during skin closure. Additionally, upon arrival in the recovery room, all patients will be connected to a PCA (Patient Controlled Analgesia) pump filled with a solution containing opioids. Patients who have NPRS scores greater than 4 during postoperative pain reassessments, despite PCA use, will be given a rescue analgesic dose of 1000 mg of paracetamol (which can be repeated after 8 hours, up to a maximum of 3000 mg in 24 hours).
Postoperative pain intensity will be assessed by investigator 3 at 0, 2, 6, 12, and 24 hours after the end of surgery using the Numeric Pain Rating Scale (NPRS). Assessments will be conducted both at rest and during coughing. Total opioid and rescue analgesic consumption, incidence of postoperative complications, and length of hospital stay will also be recorded. Twenty-four hours after the surgery, investigator 3 will administer the Quality of Recovery 15 (QoR-15) questionnaire to all patients enrolled in the study. The responses will be used by investigator 3 to calculate the QoR-15 Index, which summarizes the degree of patient satisfaction.
- Conditions
- RATS Surgery, Thymectomy, Locoregional Anesthesia, Postoperative Pain Management, Serratus Posterior Superior Intercostal Plane Block, Robotic-Assisted Thoracoscopic Surgery
- Being tested
- Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine, Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)
- Keywords
- SPSIP, RATS Thymectomy, Thymoma
- Medical subject headings
- Thymoma
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 Block performed with 0.25% bupivacaineProcedure or surgery
Also called SPSIP Block with 0.25% bupivacaine
While the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.25% bupivacaine is administered superficially to the intercostal muscle.
Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)Procedure or surgery
Also called SPSIP Block with placebo solution (0.9% NaCl)
While the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.9% NaCl is administered superficially to the intercostal muscle
| Study group | Role | What they receive |
|---|---|---|
| SPSIP group | Experimental | Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed by administering 30 ml of 0.25% bupivacaine. Receives: Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine |
| Placebo group | Placebo comparator | Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed using 30 ml of a placebo solution without an active ingredient (0.9% NaCl) Receives: Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups.
Measured: 0, 2, 6, 12, and 24 hours after the end of the surgical procedure
Secondary outcomes (5)
Total opioid drug consumption
The total number of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery
Measured: 24 hours after surgery
Consumption of rescue analgesics
The total dose of acetaminophen administered upon the patient's request during the first 24 postoperative hours
Measured: 24 hours after surgery
postoperative respiratory complications
The number of any postoperative respiratory complications in the two study groups
Measured: 24 hours after surgery
postoperative quality of recovery
the patient's level of satisfaction measured using the QoR-15 index, a numerical parameter calculated by administering the Quality of Recovery 15 (QoR-15) questionnaire to the patient
Measured: 24 hours after surgery
Length of Hospital Stay
the duration of postoperative hospitalization
Measured: from the end of the surgical procedure to patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Mar 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Sep 2026 (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 RATS SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Punzo, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSDania Nachira, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545409
- Sponsor's protocol ID
- 6729
- Acronym
- SPRATS
- Status last verified
- Mar 2025
- First submitted
- 30 Jul 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CQ, Wang J, Liu FY, Wang W. Robot-assisted thoracoscopic surgery vs. sternotomy for thymectomy: A systematic review and meta-analysis. Front Surg. 2023 Jan 6;9:1048547. doi: 10.3389/fsurg.2022.1048547. eCollection 2022.
PubMed 36684131Chao YK, Lee JY, Lu HI, Tseng YL, Lee JM, Huang WC. Robot-assisted surgery outperforms video-assisted thoracoscopic surgery for anterior mediastinal disease: a multi-institutional study. J Robot Surg. 2024 Jan 13;18(1):21. doi: 10.1007/s11701-023-01745-1.
PubMed 38217569Tulgar 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 36883093Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.
PubMed 38343684Shintani Y, Funaki S, Ose N, Kanou T, Fukui E, Kimura K, Minami M. Surgical management of thymic epithelial tumors. Surg Today. 2021 Mar;51(3):331-339. doi: 10.1007/s00595-020-02070-y. Epub 2020 Jul 10.
PubMed 32647929
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thoracoscopic Surgery for Thymectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06545409
- Acronym / sponsor ID
- SPRATS / 6729
- Conditions
- RATS Surgery, Thymectomy, Locoregional Anesthesia, Postoperative Pain Management, Serratus Posterior Superior Intercostal Plane Block, Robotic-Assisted Thoracoscopic Surgery
- Keywords
- SPSIP, RATS Thymectomy, Thymoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 9 Aug 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.
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) for postoperative pain control, reducing opioid analgesic consumption, minimizing postoperative respiratory complications, and enhancing patient satisfaction (measured using the QoR-15 index) in patients undergoing robotic thymectomy, compared to patients who do not receive the block.
Detailed description
All patients enrolled in the study will receive the SPSIP Block under ultrasound guidance 15 minutes before entering the operating room. The SPSIP Block will be performed by the attending anesthetist (investigator 1), who will use a syringe pre-filled with 30 ml of a solution prepared in advance by another investigator (investigator 2). According to the randomization scheme, the solution in the syringe used for the SPSIP Block will contain either 0.25% bupivacaine for 50% of the cases (SPSIP group) or sterile saline solution (0.9% NaCl) for the remaining 50% of the cases (control group). Postoperatively, data collection will be managed by a third investigator (investigator 3). Neither the investigator 1, the patient, nor the investigator 3 will be informed of the syringe's contents, ensuring the study is conducted blind.
All patients enrolled in the study will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of the surgery, during skin closure. Additionally, upon arrival in the recovery room, all patients will be connected to a PCA (Patient Controlled Analgesia) pump filled with a solution containing opioids. Patients who have NPRS scores greater than 4 during postoperative pain reassessments, despite PCA use, will be given a rescue analgesic dose of 1000 mg of paracetamol (which can be repeated after 8 hours, up to a maximum of 3000 mg in 24 hours).
Postoperative pain intensity will be assessed by investigator 3 at 0, 2, 6, 12, and 24 hours after the end of surgery using the Numeric Pain Rating Scale (NPRS). Assessments will be conducted both at rest and during coughing. Total opioid and rescue analgesic consumption, incidence of postoperative complications, and length of hospital stay will also be recorded. Twenty-four hours after the surgery, investigator 3 will administer the Quality of Recovery 15 (QoR-15) questionnaire to all patients enrolled in the study. The responses will be used by investigator 3 to calculate the QoR-15 Index, which summarizes the degree of patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| SPSIP group | Experimental | Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacainePatients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed by administering 30 ml of 0.25% bupivacaine. |
| Placebo group | Placebo comparator | Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed using 30 ml of a placebo solution without an active ingredient (0.9% NaCl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study.
Key exclusion criteria (11 listed)
- Patients who refuse to participate in the study by not signing the informed consent;
- Patients with myasthenia gravis, severe obesity (BMI > 35), history of OSAS with or without CPAP;
- Patients belonging to ASA classes > 3, according to the system developed by the American Society of Anesthesiologists;
- Patients unable to understand the functioning of the NPR Scale or the PCA device that will be used for postoperative analgesia;
- Patients with allergies to analgesic and/or anesthetic drugs;
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 Block performed with 0.25% bupivacaineAlso: SPSIP Block with 0.25% bupivacaineWhile the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.25% bupivacaine is administered superficially to the intercostal muscle. | Procedure or surgery | SPSIP group |
| Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)Also: SPSIP Block with placebo solution (0.9% NaCl)While the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.9% NaCl is administered superficially to the intercostal muscle | Procedure or surgery | Placebo group |
Primary outcome
Postoperative pain intensity
Time frame: 0, 2, 6, 12, and 24 hours after the end of the surgical procedure
The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups.
5 secondary outcomes
Total opioid drug consumption
Time frame: 24 hours after surgery
Consumption of rescue analgesics
Time frame: 24 hours after surgery
postoperative respiratory complications
Time frame: 24 hours after surgery
postoperative quality of recovery
Time frame: 24 hours after surgery
Length of Hospital Stay
Time frame: from the end of the surgical procedure to patient discharge
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 Mar 2025.
- Background: PubMed 36684131Wang CQ, Wang J, Liu FY, Wang W. Robot-assisted thoracoscopic surgery vs. sternotomy for thymectomy: A systematic review and meta-analysis. Front Surg. 2023 Jan 6;9:1048547. doi: 10.3389/fsurg.2022.1048547. eCollection 2022.
- Background: PubMed 38217569Chao YK, Lee JY, Lu HI, Tseng YL, Lee JM, Huang WC. Robot-assisted surgery outperforms video-assisted thoracoscopic surgery for anterior mediastinal disease: a multi-institutional study. J Robot Surg. 2024 Jan 13;18(1):21. doi: 10.1007/s11701-023-01745-1.
- 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 38343684Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.
- Results publication: PubMed 32647929Shintani Y, Funaki S, Ose N, Kanou T, Fukui E, Kimura K, Minami M. Surgical management of thymic epithelial tumors. Surg Today. 2021 Mar;51(3):331-339. doi: 10.1007/s00595-020-02070-y. Epub 2020 Jul 10.
- Individual participant dataSharing planned: No
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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.
Dania Nachira, MD contact
Giovanni Punzo, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dania Nachira, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 performed with 0.25% bupivacaine in people with RATS Surgery and Thymectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 inclusion and 11 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 Mar 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 Italy. 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. Some participants in this study may receive a placebo. 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 Giovanni Punzo, MD (0630153212 ext. +39, giovanni.punzo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: 0, 2, 6, 12, and 24 hours after the end of the surgical procedure). 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 NCT06545409, 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 Mar 2025.