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SPSIP Block and Opioid Use After MICS

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07259824
Acronym
SPSIPB-MICS
Enrollment
50
Registered
2025-12-02
Start date
2026-01-22
Completion date
2026-04-22
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valvular Disease, Minimally Invasive Cardiac Surgery, Postoperative Pain Management, Serratus Posterior Superior Intercostal Plane Block

Keywords

postoperative pain management, minimally invasive cardiac surgery, serratus posterior superior intercostal plane block, opioid consumption

Brief summary

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.

Detailed description

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.

Interventions

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.

PROCEDURESham Serratus Posterior Superior Intercostal Plane Block

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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

The anesthesiologist performing the block will be aware of group allocation, while the patients and the anesthesiologist responsible for postoperative data collection will remain blinded to the intervention. Pain assessments and other outcome measurements will be conducted by a blinded senior anesthesia resident who is unaware of which treatment each patient received.

Intervention model description

This is a prospective, randomized, controlled, parallel-group clinical trial conducted at a single center. Eligible patients scheduled for minimally invasive cardiac surgery will be randomly assigned in a 1:1 ratio to receive either the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in addition to standard analgesia or standard analgesia alone. Both groups will be managed and evaluated under the same perioperative protocol, and outcomes will be assessed by blinded observers.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total opioid consumption within 24 hours after surgery24 hours postoperativelyThe 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

MeasureTime frameDescription
Postoperative pain scores (NRS)6, 12, and 24 hours postoperativelyPain intensity will be assessed using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at rest and during deep breathing/coughing.
Extubation timeImmediate postoperative periodTime from the end of surgery to tracheal extubation (minutes).
Intraoperative opioid consumptionDuring surgeryTotal intraoperative opioid dose.
Block-related complicationsWithin 24 hours postoperativelyIncidence of pneumothorax, vascular puncture, hematoma, local anesthetic systemic toxicity, or injection site pain.
Postoperative recovery parametersWithin 48 hours postoperativelyTime to first oral intake, time to first mobilization assesment
Quality of Recovery (QoR-15) score24 and 48 hours postoperativelyPatient 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.
Modified Radiological Atelectasis Score24 and 48 hours postoperativelymodified 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORZeliha A Demir, M.D.

Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Professor of Aneshesiology

STUDY_DIRECTORAslıhan Aykut, M.D.

Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Associate Professor of Anesthesiology

STUDY_CHAIRNisan Özsan, M.D.

Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026