Serratus Posterior Superior Plane Block for Postoperative Pain in Cardiac Surgery

NCT07164677 | Recruiting

• 1 other identifier: SPSIPB2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the efficacy of bilateral serratus posterior superior intercostal plane (SPSIP) block on postoperative acute pain and opioid consumption in patients undergoing on-pump open-heart surgery. Postoperative outcomes including pain scores, cumulative morphine use, quality of recovery, and opioid-related side effects will be evaluated within the first 24 hours after surgery.

Conditions

Cardiac Surgery; Post Operative Pain, Acute

Keywords

Cardiac surgery; Serratus Posterior Superior Plane Block

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption in the first 24 hours after surgery

  The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA- administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.

  Postoperative day 1

Secondary Outcomes (8)

• Cumulative opioid consumption in the first 12 hours after surgery

  Postoperative12 hours

• Numerical Rating Scale Assessment of Postoperative Pain

  Postoperative day 1

• Intraoperative Remifentanil Consumption

  The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 250 minutes

• Time to First Opioid Demand via PCA

  Postoperative day 1

• The number of patients who required rescue analgesia.

  Postoperative day 1

Study Arms (2)

Group SPSIP

ACTIVE COMPARATOR

A bilaterally Serratus Posterior Superior Plane Block (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

Procedure: Bilateral ultrasound guided Serratus Posterior Superior Plane Block; Drug: IV morphine patient-controlled analgesia

Group Control

SHAM COMPARATOR

A bilaterally Sham block + IV morphine patient-controlled analgesia (PCA)

Drug: IV morphine patient-controlled analgesia; Procedure: Bilateral ultrasound guided Sham Block

Interventions

Bilateral ultrasound guided Serratus Posterior Superior Plane Block PROCEDURE

Bilateral ultrasound-guided Serratus Posterior Superior Plane Block (total of 60 ml, %0.25 bupivacaine) will be performed Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis.

Also known as: Serratus Posterior Superior Plane Block

Group SPSIP

IV morphine patient-controlled analgesia DRUG

IV PCA of 0,5mg/ml morphine (the bolus dose is 20 μg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).

Also known as: morphine PCA

Group Control; Group SPSIP

Bilateral ultrasound guided Sham Block PROCEDURE

Bilateral ultrasound-guided needle placement will be performed in the same anatomical plane as in the SPSIP group, but instead of local anesthetic, an equivalent volume of normal saline (30 mL per side) will be injected. Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis.

Also known as: Sham Block

Group Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy.
• American Society of Anesthesiologists (ASA) classification II-III patients.
• Patients who can use PCA.
• Patients who will sign the informed consent form.

You may not qualify if:

• History of opioid use for more than four weeks
• Chronic pain syndromes
• Patients with a history of local anesthetic or opioid allergy, hypersensitivity
• Alcohol and drug addiction
• Conditions where regional anesthesia is contraindicated
• Failure in the dermatomal examination performed after the block
• Emergency surgeries and redo surgeries.
• Individuals with obstructive sleep apnea.
• Left ventricular ejection fraction less than 30%.
• Patients with severe psychiatric illnesses (such as psychosis, dementia) that limit cooperation with verbal numerical pain scales.
• Pregnant and breastfeeding patients.
• Hematological disorders.
• Significant impairment in the function of a major organ (e.g., severe hepatic or renal disease). • Patients who cannot be extubated within the first 6 hours postoperatively.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Burhan Dost

Samsun, 55270, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Burhan Dost

  Ondokuz Mayis University, Samsun, Atakum 55139

  STUDY DIRECTOR

Central Study Contacts

Burhan Dost

CONTACT

05327042493; burhandost@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 13, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

TU (1)