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NCT Number: NCT07259824

SPSIP Block and Opioid Use After MICS

This prospective, randomized, controlled, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients undergoing minimally invasive cardiac surgery (MICS). A total of 50 patients undergoing MICS will be randomized into two groups: one receiving standard analgesia plus ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine, and a control group receiving standard analgesia only. The primary outcome is total postoperative opioid consumption within 24 hours. Secondary outcomes include postoperative pain scores, extubation time, block-related complications, and recovery parameters such as early mobilization, oral intake, Modified radiological atelectasis score and Quality of Recovery-15 scores.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

Minimally invasive cardiac surgery (MICS) is increasingly performed as an alternative to traditional sternotomy-based procedures, providing benefits such as shorter recovery time, reduced hospital stay, and improved cosmetic outcomes. However, despite smaller incisions, patients frequently experience moderate to severe postoperative pain due to rib, pleural, and intercostal nerve injury. Uncontrolled pain may impair respiratory function, delay mobilization, and increase postoperative complications, including chronic post-thoracotomy pain.

Regional anesthesia techniques play an important role in multimodal analgesia after MICS, but the optimal approach remains uncertain. Thoracic epidural and paravertebral blocks have been widely used but are often limited by safety concerns in anticoagulated patients. Recently, ultrasound-guided interfascial plane blocks have gained attention due to their simplicity and low complication rates. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB), first described in 2023, targets the fascial plane between the serratus posterior superior and intercostal muscles, typically at the second or third intercostal level, and provides broad sensory coverage from C3 to T10 dermatomes. To date, there is no published study investigating its use for pain control in MICS.

This study will be conducted at Ankara Bilkent City Hospital as a prospective, randomized, controlled, single-center clinical trial. A total of 50 patients (25 per group) aged 18-75 years (ASA II-III) scheduled for MICS will be enrolled after obtaining informed consent. Participants will be randomly assigned (1:1) to one of two groups using a computer-based randomization method:

Group SPSIPB (n=25): Standard anesthesia and analgesia + ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine (unilateral, on the surgical side).

Group Control (n=25): Standard anesthesia and analgesia only. All patients will receive intravenous tramadol (1 mg/kg) and paracetamol (1 g) at the end of surgery. Postoperative patient-controlled analgesia (PCA) with tramadol (15 mg bolus, 15-min lockout, no basal infusion) will be used in both groups. Rescue morphine (0.05 mg/kg) will be administered when NRS >4. Pain scores (NRS 0-10) will be recorded at 6, 12, and 24 hours postoperatively, both at rest and during deep breathing/coughing.

The primary outcome is total postoperative opioid consumption (morphine equivalent, mg) in the first 24 hours.

Secondary outcomes include intraoperative opioid use, postoperative pain scores, extubation time, block-related complications (e.g., pneumothorax, vascular puncture, hematoma, local anesthetic toxicity), postoperative recovery indicators (first oral intake, mobilization, respiratory function), Modified radiological atelectasis score, Quality of Recovery-15 (QoR-15) scores.

All postoperative assessments will be performed by a blinded senior anesthesia resident unaware of group allocation. Statistical analysis will be conducted using SPSS v26. Continuous variables will be analyzed with the independent t-test or Mann-Whitney U test as appropriate; categorical variables will be evaluated with chi-square or Fisher's exact test. Repeated pain scores will be compared using repeated-measures ANOVA or Friedman test. A p value <0.05 will be considered statistically significant.

The study is expected to start in January 2026. The results may provide new evidence on the effectiveness and safety of SPSIPB for postoperative analgesia in minimally invasive cardiac surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for elective minimally invasive cardiac surgery (MICS)
  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) physical status II-III
  • Body mass index (BMI) between 18 and 35 kg/m²
  • Patients who provide written informed consent for participation

Exclusion criteria

  • Known allergy or hypersensitivity to local anesthetics
  • Coagulopathy or current anticoagulant therapy
  • Pregnancy or breastfeeding
  • Impaired consciousness or inability to communicate
  • Failed or technically inadequate block
  • Refusal to undergo the block procedure
  • Cognitive or mental disorders preventing valid pain assessment
  • Opioid intolerance or contraindication to opioid use
  • Development of intraoperative or postoperative complications requiring reoperation, prolonged mechanical ventilation, or intensive care
  • Incomplete postoperative data or patient withdrawal from the study

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

Procedure

The SPSIPB will be performed under ultrasound guidance using an in-plane technique. The needle will be advanced into the fascial plane between the serratus posterior superior and intercostal muscles at the 2nd-3rd intercostal level, and 30 mL of 0.25% bupivacaine will be injected unilaterally on the surgical side. This procedure will be applied in addition to standard anesthesia and analgesia.

Sham Serratus Posterior Superior Intercostal Plane Block

Procedure

The same ultrasound-guided procedure will be performed using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. This sham block will be performed to maintain blinding, while all other anesthesia and analgesia protocols will be identical to the experimental group.

Primary outcomes

  1. Total opioid consumption within 24 hours after surgery

    Time frame: 24 hours postoperatively

    The total amount of opioids (converted to intravenous morphine equivalent, mg) administered during the first 24 postoperative hours will be recorded from the patient-controlled analgesia (PCA) device and rescue analgesic doses.

Secondary outcomes

  1. Postoperative pain scores (NRS)

    Time frame: 6, 12, and 24 hours postoperatively

    Pain intensity will be assessed using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at rest and during deep breathing/coughing.

  2. Extubation time

    Time frame: Immediate postoperative period

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

  3. Intraoperative opioid consumption

    Time frame: During surgery

    Total intraoperative opioid dose.

  4. Block-related complications

    Time frame: Within 24 hours postoperatively

    Incidence of pneumothorax, vascular puncture, hematoma, local anesthetic systemic toxicity, or injection site pain.

  5. Postoperative recovery parameters

    Time frame: Within 48 hours postoperatively

    Time to first oral intake, time to first mobilization assesment

  6. Quality of Recovery (QoR-15) score

    Time frame: 24 and 48 hours postoperatively

    Patient recovery quality will be assessed using the validated QoR-15 questionnaire.The QoR-15 is a patient-reported outcome measure consisting of 15 items scored from 0 to 10. The total score ranges from 0 (extremely poor recovery) to 150 (excellent recovery), with higher scores reflecting better postoperative quality of recovery.

  7. Modified Radiological Atelectasis Score

    Time frame: 24 and 48 hours postoperatively

    modified radiological atelectasis score will be evaluated at 24 and 48 hours after surgery. Each lung lobe, including the lingula, is scored from 0 (normal) to 3 (total atelectasis), with higher total scores indicating more severe atelectasis.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Evaluation of the Effectiveness of Serratus Posterior Superior Intercostal Plane Block in Perioperative Pain Management in Patients Undergoing Minimally Invasive Cardiac Surgery

Acronym: SPSIPB-MICS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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