Serratus Posterior Superior Plane Block for Postoperative Pain in Cardiac Surgery

NCT ID: NCT07164677

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-13
• Study Completion Date: 2026-04-01

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.

Detailed Description

Acute pain following cardiac surgery is a prevalent clinical problem that may negatively affect postoperative recovery, pulmonary function, and overall quality of life. Reported rates of moderate to severe pain after sternotomy range widely in the literature, largely due to factors such as vasospasm, heightened inflammatory responses, tissue and bone trauma during surgical dissection, and the placement of chest tubes. Although pain intensity usually subsides after the first 24 hours, inadequate analgesia during this critical period can prolong acute pain, delay mobilization, and increase the risk of chronic post-sternotomy pain syndrome.

Traditionally, neuraxial techniques such as thoracic epidural and paravertebral blocks have been used for pain management in cardiac surgery. However, their application remains controversial due to technical difficulties and patient-related risks, including coagulation disorders, complete heparinization, hemodynamic instability, and potential complications such as pneumothorax. In recent years, fascial plane chest wall blocks, including serratus anterior, parasternal blocks and erector spinae plane blocks, have gained traction as safer alternatives, particularly in patients receiving antiplatelet or anticoagulant therapy.

The serratus posterior superior intercostal plane (SPSIP) block, first described in 2023, represents a novel approach for thoracic analgesia, providing extensive dermatomal coverage from C3 to T10. By targeting the fascial plane between the serratus posterior superior and intercostal muscles, this block offers the potential for effective analgesia across cervical and thoracic regions. Preliminary reports and case series have demonstrated its promising role in thoracic and minimally invasive cardiac surgery.

This prospective, randomized, double-blind, parallel-group trial will evaluate the efficacy of bilateral SPSIP block in patients undergoing on-pump open-heart surgery. Participants will be allocated to either:

SPSIP Group: General anesthesia + SPSIP Block + Patient-Controlled Analgesia (PCA)

Control Group: General anesthesia + Sham Block + PCA

The primary outcome is cumulative morphine consumption during the first 24 postoperative hours. Secondary outcomes include acute pain scores at rest and with movement, time to first opioid demand, rescue analgesia requirements, incidence of postoperative nausea and vomiting (PONV), opioid-related side effects, intraoperative remifentanil consumption, and quality of recovery assessed by the QoR-15 questionnaire.

Conditions

Cardiac Surgery; Post Operative Pain, Acute

Study Design

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

Study Groups

Group SPSIP

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

Group Type: ACTIVE_COMPARATOR

Bilateral ultrasound guided Serratus Posterior Superior Plane Block

Intervention Type: 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.

IV morphine patient-controlled analgesia

Intervention Type: 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).

Group Control

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

Group Type: SHAM_COMPARATOR

IV morphine patient-controlled analgesia

Intervention Type: 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).

Bilateral ultrasound guided Sham Block

Intervention Type: 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.

Interventions

Bilateral ultrasound guided Serratus Posterior Superior Plane Block

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.

Intervention Type: PROCEDURE

IV morphine patient-controlled analgesia

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).

Intervention Type: DRUG

Bilateral ultrasound guided Sham Block

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.

Intervention Type: PROCEDURE

Other Intervention Names

Serratus Posterior Superior Plane Block; morphine PCA; Sham Block

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

BURHAN DOST

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burhan Dost

Role: STUDY_DIRECTOR

Ondokuz Mayis University, Samsun, Atakum 55139

Locations

Burhan Dost

Samsun, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Burhan Dost

Role: CONTACT

burhandost@hotmail.com

05327042493

Facility Contacts

BURHAN DOST

Role: primary

burhandost@hotmail.com

05327042493

Other Identifiers

SPSIPB2025

Identifier Type: -

Identifier Source: org_study_id