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NCT Number: NCT07175298

Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain in Cardiac Surgery.

Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, 21521, Egypt

Location contact

Hesham ELgoweini, Prof.Dr.

CONTACT

[email protected]

00201287740750

Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr

PRINCIPAL_INVESTIGATOR

About this study

Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.

Effective pain management is crucial for patient recovery, reducing complications, and facilitating early mobilization. Opioids are commonly used for postoperative analgesia but are associated with numerous side effects, including respiratory depression, nausea, vomiting, constipation, and prolonged hospitalization.

Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles. This block will provide analgesia to the anterolateral and posterior chest wall, covering dermatomes relevant to cardiac surgery.

Preliminary case reports and small studies suggest its efficacy in thoracic and cardiac surgeries, demonstrating effective pain control and reduced opioid consumption. However, a randomized controlled trial is necessary to definitively determine the efficacy and safety of SPSIPB as part of multimodal analgesia in adult cardiac surgery.

Fascial plane blocks in regional anesthesia have gained importance in recent years. It involves injection into a tissue plane to provide analgesia and is an alternative to neuraxial and paravertebral techniques. It is often safer and is associated with less cardiorespiratory instability or complications compared to epidural analgesia.

The primary objective of the study is to examine the effect of adding preemptive SPSIPB to general anesthesia in adult cardiac surgery through sternotomy on the postoperative opioid consumption. The secondary objectives will include time to extubation, the intensity of postoperative pain, time to 1st rescue analgesia, patient satisfaction, and any possible side effects of the study drugs and technique.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18 to 60
  • both sexes
  • who are scheduled to have fast-tracking elective on-pump cardiac surgery through a median sternotomy,
  • American Society of Anesthesiologists Physical status II-III,
  • Ability to understand and provide informed consent

Exclusion criteria

  • patients who refused to participate in the study,
  • who had Cognitive impairment or mental disorders,
  • Ages <18 and >60 years,
  • BMI <18 and >35,
  • patients with puncture site infection,
  • patients who documented allergy to local anesthetic drugs,
  • patients used to take chronic pain medications, patients who made previous sternotomy or chest surgery
  • patients with a history of substance abuse.

Treatment and study plan

conventional opioid-based technique

Procedure

Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique

SPSIPB Group

Procedure

SPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl

Primary outcomes

  1. Total postoperative fentanyl consumption

    Time frame: the first 24 and 48 hours post-extubation.

    will be measured as the total amount of fentanyl (in micrograms) consumed via PCA

Secondary outcomes

  1. Time to extubation

    Time frame: post operative 6 hour

    duration (minutes) between ICU admission and endotracheal extubation.

  2. Time to first rescue analgesia

    Time frame: 48hour post operatively

    Time from extubation to the first request for PCA bolus.

  3. Postoperative pain intensity

    Time frame: 6, 12, 18,24, 36, and 48 hours post-extubation.

    Assessed using the Critical-Care Pain Observation Tool (CPOT) during intubation and the Numerical Rating Scale (NRS), at 6, 12, 18,24, 36, and 48 hours post-extubation. The CPOT ranges from 0 to 8, and the NRS ranges from 0 (no pain) to 10 (worst possible pain).

  4. Patient satisfaction

    Time frame: at 24 hours post-extubation

    Assessed using a 5-point Likert scale ( 1-Very dissatisfied 2-Dissatisfied 3-Neutral 4-Satisfied 5-Very satisfied)

  5. Length of stay

    Time frame: post operative 5 days

    total hospital stay (days).

  6. Incidence of adverse

    Time frame: 28hour postoperative

    • Related to local anesthesia toxicity (neurologic or cardiovascular events).
    • Related to block procedure (hematoma and pneumothorax, nerve injury).
    • Related to opioid administration (postoperative nausea and vomiting, dizziness, and pruritus, respiratory depression (respiratory rate < 10breaths/min or SpO2 < 90% on room air)).

Study contacts

Contact information is provided by the study sponsor or research team.

ISLAM ELBARDAN, MD

CONTACT

[email protected]

00201112278083

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain Management in Patients Undergoing Adult Cardiac Surgery. A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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