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Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries (PIFB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134637
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Hamed, Fayoum University Hospital

Brief Summary:
The objective is to test the effect of pecto intercostal fascial plane block (PIFB) as regard its impact on pain after sternotomy involved open heart surgery. The authors hypothesize that bilateral PIFB can reduce pain resulting from sternotomy following open heart surgeries.

Condition or disease Intervention/treatment Phase
Pain, Chest Device: ultrasound Drug: Bupivacaine Hydrochloride 5 MG/ML Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain After Open Heart Surgeries
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: PIFB group

For carrying out PIFB bilaterally the skin on either side of the sternum will be prepared with povidone iodine solution. Then a linear ultrasound probe will be placed on the right and left sides at 2 cm from the sternal body.

A 22 gauge, 4 inch needle will be advanced until contacting the 4th costal cartilage following the lower edge of US probe, directing the tip from the bottom of the sternum and positioning the needle tip between the pectoralis major and the external intercostal muscles. Group A will receive twenty milliliters of a solution of 0.25% bupivacaine plus epinephrine (5 mcg/ml). Boluses of 5 ml are introduced to perform hydrodissection of the interfascial plane.

Device: ultrasound
in the PIFB group linear ultrasound (Philips clear vue350,Philips healthcare,Andover MAO1810,USA,Machine Identification number:1385,Nile medical center,service@nilemed.net) probe will be used.

Drug: Bupivacaine Hydrochloride 5 MG/ML
twenty milliliters of a solution of 0.25% bupivacaine in the PIFB group
Other Name: sunnypivacaine

No Intervention: control group
the block will not be given



Primary Outcome Measures :
  1. Cumulative morphine consumption [ Time Frame: 24 hours postoperative ]
    in milligram


Secondary Outcome Measures :
  1. postoperative sternal wound pain degree [ Time Frame: 4 hours after extubation ]

    Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing

    1 (worst) to 4 (best) not summed


  2. postoperative sternal wound pain degree [ Time Frame: 8 hours after extubation ]

    Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing

    1 (worst) to 4 (best) not summed


  3. postoperative sternal wound pain degree [ Time Frame: 12 hours after extubation ]

    Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing

    1 (worst) to 4 (best) not summed


  4. postoperative sternal wound pain degree [ Time Frame: 16 hours after extubation ]

    Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing

    1 (worst) to 4 (best) not summed


  5. postoperative sternal wound pain degree [ Time Frame: 20 hours after extubation ]

    Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing

    1 (worst) to 4 (best) not summed


  6. postoperative sternal wound pain degree [ Time Frame: 24 hours after extubation ]

    Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing

    1 (worst) to 4 (best) not summed


  7. Heart rate [ Time Frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times ]
    in beat per minute

  8. systolic blood pressure [ Time Frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times ]
    in millimeter mercury

  9. diastolic blood pressure [ Time Frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times ]
    in millimeter mercury

  10. peripheral oxygen saturation [ Time Frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times ]
    in percentage by pulse oximetry

  11. heart rate [ Time Frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times ]
    in beat per minute

  12. systolic blood pressure [ Time Frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times ]
    in millimeter mercury

  13. diastolic blood pressure [ Time Frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times ]
    in millimeter mercury

  14. peripheral oxygen saturation [ Time Frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times ]
    in percentage by pulse oximetry

  15. incidence of Myocardial infarction [ Time Frame: 1 minute after ICU admission ]
    number

  16. incidence of postoperative pericardial effusion [ Time Frame: 1 minute after ICU admission ]
    number

  17. incidence of heart failure requiring inotropic support [ Time Frame: 1 minute after ICU admission ]
    number

  18. incidence of atrial fibrillation [ Time Frame: 1 minute after ICU admission ]
    number

  19. partial pressure of oxygen [ Time Frame: 1 minute after insertion of arterial cannula ]
    by mmhg in arterial blood gases

  20. partial pressure of oxygen [ Time Frame: 1 minute after extubation ]
    by mmhg in arterial blood gases

  21. partial pressure of oxygen [ Time Frame: 6 hour after extubation ]
    by mmhg in arterial blood gases

  22. partial pressure of oxygen [ Time Frame: 12 hour after extubation ]
    by mmhg in arterial blood gases

  23. incidence of cerebral stroke [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number

  24. incidence of cerebral bleeding [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number

  25. Gastrointestinal bleeding [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number

  26. blood component requirements [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number

  27. incidence of sternal complications. [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number

  28. hospital stay [ Time Frame: 1 minute after ICU admission up to 2 days ]
    in days


Other Outcome Measures:
  1. Age [ Time Frame: 2 hours before operation ]
    in years

  2. body mass index [ Time Frame: 2 hours before operation ]
    kilogram/square meter



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective cardiovascular surgery for coronary artery bypass grafting or valve replacement involving median sternotomy

Exclusion Criteria:

  • Patients with emergency surgeries.
  • Allergy to drug used.
  • Patients with prolonged Cardio-Pulmonary Bypass time (>120 min).
  • Preoperative poor left ventricular function (ejection fraction <40%).
  • Body Mass Index >40.
  • Systemic infections or infections at site of injection.
  • Prolonged ICU stay over 24 hours for different reasons i.e.re-do surgery, heart failure etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134637


Contacts
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Contact: Alyaa A Hassan, MSc 01091169956 ext +2 aam17@fayoum.edu.eg
Contact: Hany M Yassin, MD 01111363602 ext +2 hmy00@fayoum.edu.eg

Locations
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Egypt
Fayoum university hospital
Fayoum, Egypt, 63512
Contact: Alyaa A Hassan, MSc    01091169956 ext +2    aam17@fayoum.edu.eg   
Contact: Hany M Yassin, MD    01111363602 ext +2    hmy00@fayoum.edu.eg   
Sponsors and Collaborators
Fayoum University Hospital
Investigators
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Study Chair: Maged L Boules, MD Faculty of medicine, Fayoum university
Study Director: Mohamed A Hamed, MD Faculty of medicine, Fayoum university
Publications:
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Responsible Party: Mohamed Ahmed Hamed, lecturer of anesthesia and intensive care, Fayoum University Hospital
ClinicalTrials.gov Identifier: NCT04134637    
Other Study ID Numbers: D178
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Ahmed Hamed, Fayoum University Hospital:
pecto intercostal fascial plane block
sternotomy
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents