Uniportal-VATSSPUVNCT07250373
Serratus Posterior Superior Intercostal Plane (SPSIP) Block Versus Intercostal Nerve (ICN) Block in Patients Undergoing Uniportal-VATS.
A study testing SPSIP block and ICN block in people with Uniportal-VATS and Lung Resection Procedures, 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 (SPSIP) block compared to the Intercostal Nerve (ICN) block for postoperative pain control, reduction of opioid analgesic consumption, minimization of postoperative respiratory complications, and enhancement of patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uniportal-VATS, Lung Resection Procedures, Locoregional Anesthesia
- What is being tested?
- SPSIP block and ICN block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2025to 30 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with lung neoplasm who are candidates for pulmonary resection surgery via Uniportal-VATS
- Patients who have provided informed consent to participate in the study
Who cannot join
- Patients who refuse to participate in the study by not signing the informed consent;
- Patients with severe obesity (BMI > 35), history of OSAS with or without CPAP;
- Patients classified as ASA > 3, according to the system established by the American Society of Anesthesiologists;
- Patients unable to understand the use 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 undergoing anticoagulant therapy;
Show all 11Show fewer
- Patients with a history of chronic pain;
- Patients with an infection at the site where SPSIPB or ICNB will be performed;
- Patients with a history of thoracic surgery and/or thoracic trauma with rib fractures on the side of surgery;
- Patients with chest wall deformities and/or neuromuscular diseases that interfere with normal ventilatory function.
- Additionally, patients whose surgical procedure is intraoperatively converted to an open pulmonary resection will be excluded post hoc from the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00135
About this study
Official title: Serratus Posterior Superior Intercostal Nerve (SPSIP) Block Versus Intercostal Nerve (ICN) Block in Patients Undergoing Uniportal Video-Assisted Thoracic Surgery (Uniportal-VATS): a Randomized Controlled Trial
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane (SPSIP) block compared to the Intercostal Nerve (ICN) block for postoperative pain control, reduction of opioid analgesic consumption, minimization of postoperative respiratory complications, and enhancement of patient satisfaction (measured using the QoR-15 index) in patients undergoing Uniportal Video-Assisted Thoracic Surgery (Uniportal VATS).
Read the detailed description
Patients enrolled in the study will be divided into two groups: the SPSIP group and the ICN group. Patients in the SPSIP group will receive the Serratus Posterior Superior Intercostal Plane (SPSIP) block , while those in the ICN group will receive the Intercostal Nerve (ICN) block. Both blocks will be performed at the end of surgery: the SPSIP block will be administered by the attending anesthesiologist (Investigator 1) under ultrasound guidance immediately after skin closure and before extubation, while the ICN block will be performed by the surgeon under direct vision immediately before skin closure.
All patients will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of surgery, during skin closure. Upon arrival in the recovery room, each patient will be connected to a patient-controlled analgesia (PCA) pump containing an opioid-based solution. Patients reporting a Numeric Pain Rating Scale (NPRS) score greater than 4 during postoperative reassessments, despite PCA use, will be administered a rescue analgesic dose of 1000 mg of paracetamol (repeatable after 8 hours, with a maximum of 3000 mg in 24 hours).
Postoperative pain intensity will be assessed by another investigator (Investigator 2) at 0, 2, 6, 12, and 24 hours after surgery using the NPRS, both at rest and during coughing. Total opioid consumption, rescue analgesic use, incidence of postoperative complications, and length of hospital stay will also be recorded.
Twenty-four hours after surgery, Investigator 2 will administer the Quality of Recovery-15 (QoR-15) questionnaire to all patients. The responses will be used to calculate the QoR-15 index, summarizing overall patient satisfaction. Both patients and Investigator 2 will be blinded to the type of block administered, ensuring the study is conducted in a blinded manner.
- Conditions
- Uniportal-VATS, Lung Resection Procedures, Locoregional Anesthesia, Post-operative Pain Management, Serratus Posterior Superior Intercostal Plane Block, Intercostal Nerve Block
- Being tested
- SPSIP block, ICN block
- Keywords
- SPSIP block, ICN block, Uniportal-VATS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPSIP blockOther
While the patient is in the lateral decubitus 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 local anesthetic is administered superficially to the intercostal muscle.
ICN blockOther
The ICN block will be performed by the surgeon under direct vision at the end of surgery, immediately after skin closure, by injecting 4-5 ml of local anesthetic into the intercostal spaces from levels III-IV to VII-VIII.
| 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 by the attending anesthesiologist immediately after skin closure and before extubation . Receives: Other: SPSIP block |
| ICN group | Active comparator | Patients in this group will be treated with the ICN block, administered by the surgeon under direct vision at the end of surgery and immediately before skin closure. Receives: Other: ICN block |
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: - immediately after the end of surgery; - 2 hours after the end of surgery; - 6 hours after the end of surgery; - 12 hours after the end of surgery; - 24 hours after the end of surgery.
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 the end of 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 the end of surgery.
postoperative respiratory complications
The number of any postoperative respiratory complications in the two study groups
Measured: 24 hours after the end of 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..The QoR-15 score ranges from 0 to 150, with 0 indicating the poorest postoperative recovery quality and 150 the best
Measured: 24 hours after surgery
Length of Hospital Stay
The duration of postoperative hospitalization
Measured: from the end of surgery to the date of patient discharge, assessed up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Aug 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 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 Uniportal-VATSStudies 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
- Double blind
- Who is masked
- Participant, 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
- NCT07250373
- Sponsor's protocol ID
- 7594
- Acronym
- SPUV
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avci 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 38343684Tulgar 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 36883093Guerra-Londono CE, Privorotskiy A, Cozowicz C, Hicklen RS, Memtsoudis SG, Mariano ER, Cata JP. Assessment of Intercostal Nerve Block Analgesia for Thoracic Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Nov 1;4(11):e2133394. doi: 10.1001/jamanetworkopen.2021.33394.
PubMed 34779845Nachira D, Meacci E, Petracca Ciavarella L, Chiappetta M, De Santis G, Ferretti GM, Mastromarino MG, Porziella V, Vita ML, Congedo MT, Cesario A, Ismail M, Gonzalez-Rivas D, Margaritora S. Uniportal video-assisted thoracic surgery Roman experience-a report of the first 16-month Roman experience. J Thorac Dis. 2018 Nov;10(Suppl 31):S3678-S3685. doi: 10.21037/jtd.2018.03.119.
PubMed 30505552Gonzalez-Rivas D, Paradela M, Fieira E, Velasco C. Single-incision video-assisted thoracoscopic lobectomy: initial results. J Thorac Cardiovasc Surg. 2012 Mar;143(3):745-7. doi: 10.1016/j.jtcvs.2011.07.049. Epub 2011 Aug 25. No abstract available.
PubMed 21868042
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Posterior Superior Intercostal Nerve (SPSIP) Block Versus Intercostal Nerve (ICN) Block in Patients Undergoing Uniportal Video-Assisted Thoracic Surgery (Uniportal-VATS): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07250373
- Acronym / sponsor ID
- SPUV / 7594
- Conditions
- Uniportal-VATS, Lung Resection Procedures, Locoregional Anesthesia, Post-operative Pain Management, Serratus Posterior Superior Intercostal Plane Block, Intercostal Nerve Block
- Keywords
- SPSIP block, ICN block, Uniportal-VATS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 26 Nov 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.
This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane (SPSIP) block compared to the Intercostal Nerve (ICN) block for postoperative pain control, reduction of opioid analgesic consumption, minimization of postoperative respiratory complications, and enhancement of patient satisfaction (measured using the QoR-15 index) in patients undergoing Uniportal Video-Assisted Thoracic Surgery (Uniportal VATS).
Detailed description
Patients enrolled in the study will be divided into two groups: the SPSIP group and the ICN group. Patients in the SPSIP group will receive the Serratus Posterior Superior Intercostal Plane (SPSIP) block , while those in the ICN group will receive the Intercostal Nerve (ICN) block. Both blocks will be performed at the end of surgery: the SPSIP block will be administered by the attending anesthesiologist (Investigator 1) under ultrasound guidance immediately after skin closure and before extubation, while the ICN block will be performed by the surgeon under direct vision immediately before skin closure.
All patients will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of surgery, during skin closure. Upon arrival in the recovery room, each patient will be connected to a patient-controlled analgesia (PCA) pump containing an opioid-based solution. Patients reporting a Numeric Pain Rating Scale (NPRS) score greater than 4 during postoperative reassessments, despite PCA use, will be administered a rescue analgesic dose of 1000 mg of paracetamol (repeatable after 8 hours, with a maximum of 3000 mg in 24 hours).
Postoperative pain intensity will be assessed by another investigator (Investigator 2) at 0, 2, 6, 12, and 24 hours after surgery using the NPRS, both at rest and during coughing. Total opioid consumption, rescue analgesic use, incidence of postoperative complications, and length of hospital stay will also be recorded.
Twenty-four hours after surgery, Investigator 2 will administer the Quality of Recovery-15 (QoR-15) questionnaire to all patients. The responses will be used to calculate the QoR-15 index, summarizing overall patient satisfaction. Both patients and Investigator 2 will be blinded to the type of block administered, ensuring the study is conducted in a blinded manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| SPSIP group | Experimental | Other: SPSIP blockPatients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance by the attending anesthesiologist immediately after skin closure and before extubation . |
| ICN group | Active comparator | Other: ICN blockPatients in this group will be treated with the ICN block, administered by the surgeon under direct vision at the end of surgery and immediately before skin closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age with lung neoplasm who are candidates for pulmonary resection surgery via Uniportal-VATS
- Patients who have provided informed consent to participate in the study
Key exclusion criteria (11 listed)
- Patients who refuse to participate in the study by not signing the informed consent;
- Patients with severe obesity (BMI > 35), history of OSAS with or without CPAP;
- Patients classified as ASA > 3, according to the system established by the American Society of Anesthesiologists;
- Patients unable to understand the use 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 |
|---|---|---|
| SPSIP blockWhile the patient is in the lateral decubitus 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 local anesthetic is administered superficially to the intercostal muscle. | Other | SPSIP group |
| ICN blockThe ICN block will be performed by the surgeon under direct vision at the end of surgery, immediately after skin closure, by injecting 4-5 ml of local anesthetic into the intercostal spaces from levels III-IV to VII-VIII. | Other | ICN group |
Primary outcome
Postoperative pain intensity
Time frame: - immediately after the end of surgery; - 2 hours after the end of surgery; - 6 hours after the end of surgery; - 12 hours after the end of surgery; - 24 hours after the end of surgery.
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 the end of surgery.
Consumption of rescue analgesics
Time frame: 24 hours after the end of surgery.
postoperative respiratory complications
Time frame: 24 hours after the end of surgery
postoperative quality of recovery
Time frame: 24 hours after surgery
Length of Hospital Stay
Time frame: from the end of surgery to the date of patient discharge, assessed up to 3 weeks
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 26 Nov 2025.
- 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.
- 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 34779845Guerra-Londono CE, Privorotskiy A, Cozowicz C, Hicklen RS, Memtsoudis SG, Mariano ER, Cata JP. Assessment of Intercostal Nerve Block Analgesia for Thoracic Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Nov 1;4(11):e2133394. doi: 10.1001/jamanetworkopen.2021.33394.
- Background: PubMed 30505552Nachira D, Meacci E, Petracca Ciavarella L, Chiappetta M, De Santis G, Ferretti GM, Mastromarino MG, Porziella V, Vita ML, Congedo MT, Cesario A, Ismail M, Gonzalez-Rivas D, Margaritora S. Uniportal video-assisted thoracic surgery Roman experience-a report of the first 16-month Roman experience. J Thorac Dis. 2018 Nov;10(Suppl 31):S3678-S3685. doi: 10.21037/jtd.2018.03.119.
- Background: PubMed 21868042Gonzalez-Rivas D, Paradela M, Fieira E, Velasco C. Single-incision video-assisted thoracoscopic lobectomy: initial results. J Thorac Cardiovasc Surg. 2012 Mar;143(3):745-7. doi: 10.1016/j.jtcvs.2011.07.049. Epub 2011 Aug 25. No abstract available.
- 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. This study is not recruiting at the moment.
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 SPSIP block and ICN block in people with Uniportal-VATS and Lung Resection Procedures, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: - immediately after the end of surgery; - 2 hours after the end of surgery; - 6 hours after the end of surgery; - 12 hours after the end of surgery; - 24 hours after the end of 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 NCT07250373, 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 26 Nov 2025.