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PainNCT07420712

Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery

A study testing Serratus Posterior Superior Intercostal Plane Block in people with Pain and Analgesia, run by Kartal Kosuyolu High Speciality Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-centre, prospective, randomised controlled trial investigates whether preoperative ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) reduces postoperative opioid consumption and pain scores in adults undergoing elective minimally invasive cardiac surgery through a right or left… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Analgesia
What is being tested?
Serratus Posterior Superior Intercostal Plane Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2026to 1 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • Age 18 years or older
  • American Society of Anesthesiologists physical status I-III
  • Elective minimally invasive cardiac surgery through a right or left minithoracotomy, irrespective of the cardiac procedure (coronary artery bypass grafting with or without cardiopulmonary bypass, valve surgery, atrial septal defect closure or cardiac tumour excision)
  • Written informed consent

Who cannot join

  • Bleeding diathesis
  • Anticoagulant therapy
  • Known allergy to local anaesthetics, non-steroidal anti-inflammatory drugs or opioids
  • Infection at the block site
  • Severe preoperative haemodynamic instability or uncontrolled arrhythmia
  • Refusal to participate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kosuyolu High Specialization Training and Research Hospital

    Istanbul, 34870

Other trials in Turkey (Türkiye)

About this study

Official title: Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Minimally Invasive Cardiac Surgery Via Thoracotomy: A Randomised Controlled Trial

This single-centre, prospective, randomised controlled trial investigates whether preoperative ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) reduces postoperative opioid consumption and pain scores in adults undergoing elective minimally invasive cardiac surgery through a right or left minithoracotomy. Patients are randomly allocated in a 1:1 ratio to receive SPSIPB with 30 mL of 0.25% bupivacaine or no block. Both groups receive the same postoperative analgesic regimen, consisting of intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia. The primary outcome is cumulative tramadol consumption during the first 24 h after extubation. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption and haemodynamic responses.

Read the detailed description

Study design and setting: This is a single-centre, prospective, randomised controlled, parallel-group trial with a 1:1 allocation ratio, conducted at Kosuyolu High Specialization Education and Research Hospital, Istanbul, Turkey. Ethics committee approval (2025/12/1164) covers elective minimally invasive cardiac procedures performed through a right or left minithoracotomy.

Participants: Adults with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective minimally invasive cardiac surgery through a right or left minithoracotomy, irrespective of the cardiac procedure (coronary artery bypass grafting with or without cardiopulmonary bypass, valve surgery, atrial septal defect closure or cardiac tumour excision).

Randomisation and blinding: An investigator who is not involved in block performance or outcome assessment generates the allocation sequence using block randomisation (block size of six; 1:1 allocation) and places assignments in sequentially numbered, sealed, opaque envelopes. The principal investigator, who performs all blocks, opens the envelope immediately before the procedure. The anaesthesiologist responsible for intraoperative management, surgical team, intensive care unit staff, nurses and acute pain team performing postoperative assessments are unaware of group allocation. Patients are not explicitly informed of their allocation; no sham block is performed in the control group.

Intervention: In the SPSIPB group, ultrasound-guided serratus posterior superior intercostal plane block is performed in the block room approximately 30 min before transfer to the operating room, with the patient in the lateral decubitus position and the operative side uppermost. The needle is advanced in-plane in a caudocranial direction until its tip is positioned between the serratus posterior superior muscle and the third rib, followed by injection of 30 mL of 0.25% bupivacaine. No regional block is performed in the control group.

Anaesthesia and analgesia: General anaesthesia is standardised in both groups using propofol, rocuronium and sevoflurane. Intraoperative remifentanil infusion is titrated to maintain systolic blood pressure within ±20% of the pre-incision value. Postoperatively, all patients receive intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia (10-mg bolus, 15-min lockout interval, no basal infusion, maximum 100 mg over 4 h and 400 mg over 24 h). Intravenous tenoxicam 20 mg is administered as rescue analgesia for a numeric rating scale (NRS) score ≥4 at rest and/or on movement.

Assessments and outcomes: The primary outcome is cumulative tramadol consumption recorded from the patient-controlled analgesia device during the first 24 h after extubation. Blinded nurses and the acute pain team assess NRS pain scores at rest and during shoulder flexion, as well as postoperative nausea and vomiting, at 1, 4, 8, 16 and 24 h after extubation. Secondary outcomes include rescue analgesia requirements, intraoperative remifentanil consumption, the change in systolic blood pressure 1 min after skin incision, time to extubation and intensive care unit length of stay. The timing of the first rescue analgesic dose and other perioperative haemodynamic variables are also recorded.

Conditions
Pain, Analgesia
Being tested
Serratus Posterior Superior Intercostal Plane Block
Keywords
Serratus posterior superior intercostal plane block (SPSIPB), minimally invasive cardiac surgery, minithoracotomy, regional anaesthesia, postoperative analgesia
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery

    Procedure: Serratus posterior superior intercostal plane block With the patient in the lateral decubitus position (operative side up), an 80-mm, 22-G block needle is advanced in-plane in a caudocranial direction under ultrasound guidance until its tip lies between the serratus posterior superior muscle and the third rib; after hydrodissection with 1-2 mL of saline, 30 mL of 0.25% bupivacaine is injected. The block is performed approximately 30 min before transfer to the operating room.

    Other name: SPSIPB Arm: SPSIPB group

    .

Study groups in NCT07420712
Study groupRoleWhat they receive
SPSIPB GroupExperimentalUltrasound-guided serratus posterior superior intercostal plane block on the side of the thoracotomy (30 mL of 0.25% bupivacaine), performed before induction of general anaesthesia, plus standard postoperative analgesia (intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia).
Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block
Control GroupNo interventionNo regional block. Standard postoperative analgesia only (intravenous paracetamol 1 g every 8 h and intravenous tramadol patient-controlled analgesia).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative tramadol consumption

    Total tramadol delivered by intravenous patient-controlled analgesia (mg).

    Measured: First 24 hours after extubation

Secondary outcomes (8)
  1. Resting pain scores 1 to 24 hours after extubation

    Pain at rest on the NRS (0-10).

    Measured: 1, 4, 8, 16 and 24 hours after extubation

  2. Pain scores on movement

    Pain during shoulder flexion on the NRS (0-10).

    Measured: 1, 4, 8, 16 and 24 hours after extubation

  3. Rescue analgesia requirement

    Number of patients who receive intravenous tenoxicam 20 mg as rescue analgesia for an NRS score ≥ 4 at rest and/or on movement.

    Measured: First 24 hours after extubation

  4. Intraoperative remifentanil consumption

    Total remifentanil infused during surgery (µg).

    Measured: From induction of anaesthesia to the end of surgery

  5. Change in systolic blood pressure at skin incision

    Change in invasive systolic blood pressure from the pre-incision value to 1 minute after skin incision (mmHg).

    Measured: Immediately before and 1 minute after skin incision

  6. Postoperative nausea and vomiting

    Number of patients with nausea or vomiting, defined as a highest score ≥ 1 within 24 hours on a 0-3 scale (0 = none; 1 = nausea without vomiting; 2 = a single episode of vomiting or persistent nausea; 3 = recurrent vomiting or severe retching), assessed at 1, 4, 8, 16 and 24 hours after extubation.

    Measured: First 24 hours after extubation

  7. Time to extubation

    Time from the end of surgery to tracheal extubation (h).

    Measured: From the end of surgery to extubation, up to 24 hours

  8. Length of intensive care unit stay

    Time from intensive care unit admission to discharge (h).

    Measured: From intensive care unit admission to discharge, up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start20 Feb 2026
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

Resources

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
Single-centre, prospective, randomised, controlled, parallel-group trial with 1:1 allocation.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07420712
Sponsor's protocol ID
2025/12/1164
Status last verified
Oct 2026
First submitted
4 Feb 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published results, the study protocol and the statistical analysis code will be available from the corresponding author on reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Serratus Posterior Superior Intercostal Plane Block in people with Pain and Analgesia, run by Kartal Kosuyolu High Speciality 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 4 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: finished, as of the sponsor's last update on 26 Oct 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cumulative tramadol consumption (time frame: First 24 hours after extubation). 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 26 Oct 2026.

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