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Clinical Trials/NCT06559683
NCT06559683
Completed
Not Applicable

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

Ondokuz Mayıs University1 site in 1 country33 target enrollmentSeptember 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Ondokuz Mayıs University
Enrollment
33
Locations
1
Primary Endpoint
Extent of Sensory Blockade Measured by Cold Sensation Testing Across the Anterior Chest Wall Following Deep and Superficial Parasternal Intercostal Plane Blocks.
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2024
End Date
February 27, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

BURHAN DOST

associate professor

Ondokuz Mayıs University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Acute pain scores(Postoperative Day 1)
  • Regression of Sensory Blockade at 12 and 24 Hours Post-Block(Postoperative Day 1)
  • Opioid Consumption(Postoperative Day 1)

Study Sites (1)

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