SPSIP Block and Opioid Use After MICS

NCT07259824 | Completed

• 1 other identifier: NisanOzsan
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption within 24 hours after surgery

  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.

  24 hours postoperatively

Secondary Outcomes (7)

• Postoperative pain scores (NRS)

  6, 12, and 24 hours postoperatively

• Extubation time

  Immediate postoperative period

• Intraoperative opioid consumption

  During surgery

• Block-related complications

  Within 24 hours postoperatively

• Postoperative recovery parameters

  Within 48 hours postoperatively

Study Arms (2)

SPSIPB Group

EXPERIMENTAL

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.

Procedure: Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

Sham Block Group

SHAM COMPARATOR

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.

Procedure: Sham Serratus Posterior Superior Intercostal Plane Block

Interventions

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.

Sham Block Group

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.

SPSIPB Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 39101308 BACKGROUND

• 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.

  PMID: 38343684 BACKGROUND

• 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.

  PMID: 39600439 BACKGROUND

• 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.

  PMID: 40272720 BACKGROUND

• 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.

  PMID: 38999504 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Zeliha A Demir, M.D.

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

  PRINCIPAL INVESTIGATOR

• Aslıhan Aykut, M.D.

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

  STUDY DIRECTOR

• Nisan Özsan, M.D.

  Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: January 22, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 22, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)