SPSIP Block and Opioid Use After MICS

NCT ID: NCT07259824

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-22
• Study Completion Date: 2026-05-01

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, and patient satisfaction.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SPSIPB Group

Patients in this group will receive ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with 30 mL of 0.25% bupivacaine in addition to standard anesthesia and analgesia.

Group Type: EXPERIMENTAL

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

Intervention Type: 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 Block Group

Patients in this group will undergo the same ultrasound-guided block procedure using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. All other anesthesia and analgesia protocols will be identical to the experimental group.

Group Type: SHAM_COMPARATOR

Sham Serratus Posterior Superior Intercostal Plane Block

Intervention Type: 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.

Interventions

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

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.

Intervention Type: PROCEDURE

Sham 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Nisan Özsan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeliha A Demir, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Aslıhan Aykut, M.D.

Role: STUDY_DIRECTOR

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

Nisan Özsan, M.D.

Role: STUDY_CHAIR

Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Nisan Özsan, M.D.

Role: CONTACT

nisanntass@gmail.com

+905057154560

Facility Contacts

Nisan Özsan, M.D.

Role: primary

nisanntass@gmail.com

+905057154560

Zeliha Aslı Demir, Professor

Role: backup

zaslidem@gmail.com

+90 5052491598

References

Turan EI, Isik S, Baydemir AE, Sahin AS. Serratus posterior superior intercostal plane block for postoperative analgesia in clavicle surgeries: new indications for a novel block. Minerva Anestesiol. 2024 Nov;90(11):1058-1060. doi: 10.23736/S0375-9393.24.18275-2. Epub 2024 Aug 5. No abstract available.

Reference Type: BACKGROUND

PMID: 39101308 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38343684 (View on PubMed)

Shimizu C, Wakimoto M, Kita T. Efficacy of epidural anesthesia in minimally invasive cardiac surgery. Saudi J Anaesth. 2024 Oct-Dec;18(4):528-533. doi: 10.4103/sja.sja_334_24. Epub 2024 Oct 2.

Reference Type: BACKGROUND

PMID: 39600439 (View on PubMed)

Dost B, Turunc E, Aydin ME, Kaya C, Aykut A, Demir ZA, Narayanan M, De Cassai A. Pain Management in Minimally Invasive Cardiac Surgery: A Review of Current Clinical Evidence. Pain Ther. 2025 Jun;14(3):913-930. doi: 10.1007/s40122-025-00739-1. Epub 2025 Apr 24.

Reference Type: BACKGROUND

PMID: 40272720 (View on PubMed)

Piekarski F, Rohner M, Monsefi N, Bakhtiary F, Velten M. Anesthesia for Minimal Invasive Cardiac Surgery: The Bonn Heart Center Protocol. J Clin Med. 2024 Jul 5;13(13):3939. doi: 10.3390/jcm13133939.

Reference Type: BACKGROUND

PMID: 38999504 (View on PubMed)

Other Identifiers

NisanOzsan

Identifier Type: -

Identifier Source: org_study_id