Influence of Superficial Parasternal Intercostal Plane Block on Internal Thoracic Artery Caliber to Facilitate Surgical Harvesting in CABG (IMA CABG PIPB)

June 17, 2026 updated by: sarah hamdy, Ain Shams University
Influence of Superficial Parasternal Intercostal Plane Block (SPIPB) on Internal Thoracic Artery (ITA) Caliber and Surgical Harvesting Efficiency in Coronary Artery Bypass Grafting (CABG)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Parasternal intercostal blocks (PSB) represent a newer approach to post-sternotomy pain management. Studies suggest their effectiveness in providing postoperative analgesia , with a significant advantage being their suitability even during concurrent antiplatelet or anticoagulant therapy.In addition to its sympatholytic effects cause vasodilatation , a reduction in vascular resistance, and an increase in local blood flow . The effects are maintained up to the early postoperative period .

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Faculty of Medicine ,Ain Shams University

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

Description

Inclusion Criteria:

  • • Age group: Adult patients from age of 22 to 65 years.

    • Sex: Both sexes
    • Patients undergoing CABG with IMA harvesting

Exclusion Criteria:

  • • Patients with pre-existing active bloodstream infection or systemic infection

    • Refuse consent
    • IMA graft not suitable
    • Morbidly obese (BMI > 40 )
    • Hemodynamic instability
    • Severe pulmonary disease
    • Previous thoracic surgeries (makes it difficult to harvest IMA)
    • Advanced malignancy or chronic disease with life expectancy less than six months
    • Emergency surgery

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine group
10 ml of bupivacaine solution will be administered. Dose: 10 ml bupivacaine concentration 0.5% (each 1 ml contains 5 mg; total volume 10 ml equivalent to total 50 mg) will be given.
Drug: Bupivacaine
Superficial parasternal block will be given to assess diameter of IMA by using US to assess caliber and ease of harvesting.
No Intervention: Control group
No intervention will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Internal Thoracic Artery (ITA) Diameter
Time Frame: Measured 15 minutes after the SPIPB injection by intraoperative ultrasound.
Change in the diameter of the Internal Thoracic Artery (ITA) measured in millimeters (mm) after SPIPB administration.
Measured 15 minutes after the SPIPB injection by intraoperative ultrasound.
Change in Internal Thoracic Artery (ITA) Cross-Sectional Area
Time Frame: Measured 15 minutes after the SPIPB injection by Intraoperative ultrasound.
Change in the cross-sectional area of the Internal Thoracic Artery (ITA) measured in square millimeters (mm²) after SPIPB administration.
Measured 15 minutes after the SPIPB injection by Intraoperative ultrasound.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Required for ITA Harvesting
Time Frame: Measured during the surgical harvesting procedure.
Total time in minutes (min) required to harvest the Internal Thoracic Artery.
Measured during the surgical harvesting procedure.
Technical Difficulty of ITA Harvesting
Time Frame: Assessed by the surgeon immediately after the harvesting procedure.
Assessed using a Technical Difficulty Scale. The scale ranges from 1 (Very Easy) to 5 (Very Difficult), where a higher score indicates a worse outcome (more difficult harvesting).
Assessed by the surgeon immediately after the harvesting procedure.
Postoperative Pain Score
Time Frame: Measured at 24 hours postoperatively.
Postoperative pain assessed using the Visual Analog Scale (VAS) for pain. The scale ranges from 0 mm (No Pain) to 100 mm (Worst Possible Pain), where a higher score indicates a worse outcome.
Measured at 24 hours postoperatively.
Postoperative Opioid Consumption
Time Frame: Measured over the first 24 hours postoperatively.
Total postoperative opioid consumption, measured in Morphine Milligram Equivalents (MME).
Measured over the first 24 hours postoperatively.
Intraoperative Hemodynamic Stability
Time Frame: Measured during the intraoperative period.
Incidence of significant hemodynamic instability (e.g., episodes of hypotension or hypertension requiring intervention).
Measured during the intraoperative period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Sarah H Elghareeb, MD, Ain Shams

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Subscribe