NCT06559683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

September 14, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

August 13, 2024

Last Update Submit

February 28, 2025

Conditions

Keywords

analgesiapain Managementsensory assessment

Outcome Measures

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.

    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.

    30 minutes after the blocks

Secondary Outcomes (3)

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

    Postoperative Day 1

  • Opioid Consumption

    Postoperative Day 1

  • Acute pain scores

    Postoperative Day 1

Study Arms (2)

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.

Other: Sensory Assessment

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.

Other: Sensory Assessment

Interventions

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.

Deep ParasternalSuperficial Parasternal

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 19, 2024

Study Start

September 14, 2024

Primary Completion

February 1, 2025

Study Completion

February 27, 2025

Last Updated

March 5, 2025

Record last verified: 2025-02

Locations