Serratus Posterior Superior Plane Block for Postoperative Pain in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bilateral ultrasound guided Serratus Posterior Superior Plane Block, IV morphine patient-controlled analgesia, Bilateral ultrasound guided Sham Block.
- Who it may be relevant to
- Registry conditions: Cardiac Surgery, Post Operative Pain, Acute. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Acute Pain Management in Open-Heart Surgery
Overview
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.
Interventions
- Procedure 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 ibup - Drug 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). - Procedure 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 mo
Primary outcome measures
- Cumulative opioid consumption in the first 24 hours after surgery [Time frame: Postoperative day 1]
Secondary outcome measures (8)
- Cumulative opioid consumption in the first 12 hours after surgery [Time frame: Postoperative12 hours]
- Numerical Rating Scale Assessment of Postoperative Pain [Time frame: Postoperative day 1]
- Intraoperative Remifentanil Consumption [Time frame: 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 [Time frame: Postoperative day 1]
- The number of patients who required rescue analgesia. [Time frame: Postoperative day 1]
- The patient number of Rescue antiemetic Requirement [Time frame: Postoperative day 1]
- The number of patients with complications [Time frame: Postoperative 7 days on an average]
- Patients' satisfaction and quality of pain management [Time frame: preoperative day 1 and Postoperative day 1]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Burhan Dost — Samsun
Identifiers
NCT: NCT07164677 · SPSIPB2025