Heart Valve DiseaseNCT07588230
Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery
A study testing Serratus Posterior Superior Intercostal Plane Block With Bupivacaine and Serratus Posterior Superior Intercostal Plane Block With Saline in people with Heart Valve Disease and Postoperative Pain, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Valve Disease, Postoperative Pain
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block With Bupivacaine and Serratus Posterior Superior Intercostal Plane Block With Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2026to 26 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
- Adult patients aged 18-75 years
- ASA physical status I-III
- Scheduled for elective minimally invasive cardiac valve surgery via mini-thoracotomy
- Able to understand and use the Numeric Rating Scale (NRS)
- Provided written informed consent
Who cannot join
- Age >75 years
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
- Coagulopathy or ongoing anticoagulant therapy that cannot be discontinued
- Infection at the planned block site
- Chronic opioid use or chronic pain conditions
- Severe pulmonary disease affecting respiratory assessment
Show all 10Show fewer
- Neurological or psychiatric disorders interfering with pain assessment
- Emergency surgery
- Pregnancy or breastfeeding
- Refusal to participate
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
Fatma Acil
Diyarbakır, Outside of the US, 21070
Fatma Acil, M.D., +905337225225, acilfatma@gmail.com
About this study
Official title: Preoperative Serratus Posterior Superior Intercostal Plane Block for Analgesia and Opioid Sparing in Patients Undergoing Minimally Invasive Cardiac Valve Surgery Via Mini-Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled Trial
This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.
Read the detailed description
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential.
Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors.
The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.
- Conditions
- Heart Valve Disease, Postoperative Pain
- Being tested
- Serratus Posterior Superior Intercostal Plane Block With Bupivacaine, Serratus Posterior Superior Intercostal Plane Block With Saline
- Keywords
- Cardiac Surgery, Postoperative Pain
- Medical subject headings
- Heart Valve Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane Block With BupivacaineProcedure or surgery
Also called SPSIP Block
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.
Serratus Posterior Superior Intercostal Plane Block With SalineProcedure or surgery
Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block with Bupivacaine | Experimental | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with bupivacaine prior to surgery, in addition to standard general anesthesia and multimodal analgesia. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block With Bupivacaine |
| Serratus Posterior Superior Intercostal Plane Block with Saline | Placebo comparator | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block With Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour cumulative opioid consumption
Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME).
Measured: 24 hours after surgery
Secondary outcomes (7)
Postoperative pain intensity at rest (NRS)
Pain intensity at rest measured using the Numeric Rating Scale (0-10).
Measured: 4, 6, 12, and 24 hours after surgery
Postoperative pain during movement (NRS)
Pain intensity during coughing or deep breathing measured using the Numeric Rating Scale (0-10).
Measured: 4, 6, 12, and 24 hours after surgery
Time to first rescue analgesia
Time from the end of surgery to the first administration of rescue analgesia.
Measured: Within 24 hours after surgery
Time to extubation
Time from the end of surgery to extubation.
Measured: From the end of surgery until extubation, assessed up to 24 hours
Length of intensive care unit stay
Duration of stay in the intensive care unit.
Measured: Through study completion, an average of 48 hours
Length of hospital stay
Total duration of hospitalization.
Measured: From date of admission until discharge, up to 30 days
Inspiratory Spirometry Test
Inspiratory spirometry performance will be assessed using an incentive spirometer. Inspiratory capacity will be estimated based on the number of rising balls: 1 ball = 600 mL, 2 balls = 900 mL, and 3 balls = 1200 mL. The score ranges from a minimum of 1 ball to a maximum of 3 balls, with higher scores indicating better inspiratory function.
Measured: 4, 6, 12, and 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 posted14 May 2026
- Study start16 May 2026
- Primary completion25 Oct 2026 (estimated)
- Study completion26 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either SPSIP block with bupivacaine or SPSIP block with saline. Both groups will undergo identical procedures under standardized conditions, and outcomes will be compared between parallel groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, M.D., Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588230
- Sponsor's protocol ID
- 07/04/2026-132
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Serratus Posterior Superior Intercostal Plane Block for Analgesia and Opioid Sparing in Patients Undergoing Minimally Invasive Cardiac Valve Surgery Via Mini-Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07588230
- Acronym / sponsor ID
- 07/04/2026-132
- Conditions
- Heart Valve Disease, Postoperative Pain
- Keywords
- Cardiac Surgery, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 16 May 2026 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 26 Oct 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.
Detailed description
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential.
Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors.
The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either SPSIP block with bupivacaine or SPSIP block with saline. Both groups will undergo identical procedures under standardized conditions, and outcomes will be compared between parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block with Bupivacaine | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane Block With BupivacaineParticipants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with bupivacaine prior to surgery, in addition to standard general anesthesia and multimodal analgesia. |
| Serratus Posterior Superior Intercostal Plane Block with Saline | Placebo comparator | Procedure: Serratus Posterior Superior Intercostal Plane Block With SalineParticipants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18-75 years
- ASA physical status I-III
- Scheduled for elective minimally invasive cardiac valve surgery via mini-thoracotomy
- Able to understand and use the Numeric Rating Scale (NRS)
- Provided written informed consent
Key exclusion criteria (10 listed)
- Age >75 years
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
- Coagulopathy or ongoing anticoagulant therapy that cannot be discontinued
- Infection at the planned block site
- Chronic opioid use or chronic pain conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block With BupivacaineAlso: SPSIP BlockParticipants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block with Bupivacaine |
| Serratus Posterior Superior Intercostal Plane Block With SalineParticipants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block with Saline |
Primary outcome
24-hour cumulative opioid consumption
Time frame: 24 hours after surgery
Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME).
7 secondary outcomes
Postoperative pain intensity at rest (NRS)
Time frame: 4, 6, 12, and 24 hours after surgery
Postoperative pain during movement (NRS)
Time frame: 4, 6, 12, and 24 hours after surgery
Time to first rescue analgesia
Time frame: Within 24 hours after surgery
Time to extubation
Time frame: From the end of surgery until extubation, assessed up to 24 hours
Length of intensive care unit stay
Time frame: Through study completion, an average of 48 hours
Length of hospital stay
Time frame: From date of admission until discharge, up to 30 days
Inspiratory Spirometry Test
Time frame: 4, 6, 12, and 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 19 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
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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.
Fatma Acil, M.D. principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Intercostal Plane Block With Bupivacaine and Serratus Posterior Superior Intercostal Plane Block With Saline in people with Heart Valve Disease and Postoperative Pain, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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 5 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Fatma Acil, M.D. (+905337225225, acilfatma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour cumulative opioid consumption (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.