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NCT Number: NCT06559683

Comparison of Sensory Analysis After Superficial and Deep Parasternal Intercostal Plane Blocks

Postoperative pain following cardiac surgery is a common issue that can negatively impact patients' quality of life. Effective perioperative pain management is crucial to improving patient outcomes. Pain is typically most intense during the first two postoperative days, and inadequate management can lead to chronic pain, further diminishing quality of life. Recent advances in ultrasound-guided regional anesthesia, including superficial and deep parasternal intercostal plane blocks, have enhanced acute pain control. These blocks aim to provide analgesia by targeting the anterior cutaneous branches of the T2-6 thoracic nerves. While their efficacy is recognized, sensory evaluation and dermatomal analysis remain unexplored. Cadaver studies suggest that the deep block may cover more parasternal space than the superficial block.

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Key information

Conditions

Pain, Postoperative Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

About this study

This observational study evaluates sensory blocks in patients undergoing open-heart surgery who receive superficial or deep parasternal intercostal plane blocks. Sensory assessment, conducted by a blinded researcher 30 minutes post-block, involves applying small ice tubes with cold sensations categorized as Normal, Reduced, or No cold. A successful block is defined as the loss or reduction of cold sensitivity, while normal cold sensation indicates block failure. Assessments start at the midline, moving laterally to the anterior axillary line. Marked areas are digitally analyzed. Block regression is evaluated at 12 and 24 hours post-procedure using the same cold assessment criteria.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who will undergo effective open heart surgery with median sternotomy
  • Patients who have undergone superficial or deep parasternal intercostal plane block

Exclusion criteria

  • Patients with severe psychiatric illnesses such as psychosis or dementia that would prevent communication with the patient
  • Patients who do not want to participate in the study
  • Redo surgeries
  • Patients whose block is considered unsuccessful with the cold application test at the 30th minute
  • Patients who cannot be extubated 12 hours post-block.

Treatment and study plan

Sensory Assessment

Other

Patients scheduled for open-heart surgery will receive a deep/superficial parasternal intercostal plane block preoperatively, and sensory block status will be evaluated after 30 minutes.

Primary outcomes

  1. Extent of Sensory Blockade Measured by Cold Sensation Testing Across the Anterior Chest Wall Following Deep and Superficial Parasternal Intercostal Plane Blocks.

    Time frame: 30 minutes after the blocks

    Participants will undergo sensory assessment using standardized cold sensation test at 30 minutes post-block to evaluate the maximum sensory blockade. The data will be recorded as the area of sensory loss (in cm) along the anterior chest wall, and the results will be aggregated to report the maximum area of sensory blockade achieved for both deep and superficial blocks. Cold sensation will be categorized as Normal Cold, Reduced Cold, or No Cold Sensation. A successful block is defined as a complete loss or reduction of cold sensitivity.

Secondary outcomes

  1. Regression of Sensory Blockade at 12 and 24 Hours Post-Block

    Time frame: Postoperative Day 1

    Block regression will be evaluated at 12 and 24 hours after block administration using cold sensation testing with ice tubes. The cold sensation will be categorized as Normal Cold, Reduced Cold, or No Cold Sensation. Participants who report Normal Cold sensation will be considered to have experienced block regression.

  2. Opioid Consumption

    Time frame: Postoperative Day 1

    Opioid consumption at 12, and 24 hours after block administration will be measured by IV patient controlled analgesia.

  3. Acute pain scores

    Time frame: Postoperative Day 1

    Pain status at rest and while coughing will be assessed by Numeric Rating Scale (NRS) scores at 12, and 24 hours after block administration.The NRS is an 11-point numeric scale which ranges from 0 to 10.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Comparison of Maximum Extension of Sensory Assessment Following Superficial and Deep Parasternal Intercostal Plane Blocks

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Mar 5, 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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