- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06559683
Comparison of Sensory Analysis After Superficial and Deep Parasternal Intercostal Plane Blocks
February 28, 2025 updated by: BURHAN DOST, Ondokuz Mayıs University
Comparison of Maximum Extension of Sensory Assessment Following 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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Samsun, Turkey
- Ondokuz Mayis University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for median sternotomy as part of open-heart surgery and who have received either a superficial or deep parasternal intercostal plane block will be enrolled
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Deep Parasternal
Patients scheduled for open-heart surgery will receive a deep parasternal intercostal plane block preoperatively, and sensory block status will be evaluated 30 minutes later using small ice tubes.
|
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.
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|
Superficial Parasternal
Patients scheduled for open-heart surgery will receive a superficial parasternal intercostal plane block preoperatively, and sensory block status will be evaluated 30 minutes later using small ice tubes.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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.
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30 minutes after the blocks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Postoperative Day 1
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Opioid Consumption
Time Frame: Postoperative Day 1
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Opioid consumption at 12, and 24 hours after block administration will be measured by IV patient controlled analgesia.
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Postoperative Day 1
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Acute pain scores
Time Frame: Postoperative Day 1
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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.
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Postoperative Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Burhan Dost, M.D., Ondokuz Mayıs University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2024
Primary Completion (Actual)
February 1, 2025
Study Completion (Actual)
February 27, 2025
Study Registration Dates
First Submitted
August 13, 2024
First Submitted That Met QC Criteria
August 15, 2024
First Posted (Actual)
August 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 28, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SensoryParasternal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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