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

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ClinicalTrials.gov Identifier: NCT04134637
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Hamed, Fayoum University Hospital

Tracking Information
First Submitted Date  ICMJE July 12, 2019
First Posted Date  ICMJE October 22, 2019
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2019)
Cumulative morphine consumption [ Time Frame: 24 hours postoperative ]
in milligram
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • incidence of Myocardial infarction [ Time Frame: 1 minute after ICU admission ]
    number
  • incidence of postoperative pericardial effusion [ Time Frame: 1 minute after ICU admission ]
    number
  • incidence of heart failure requiring inotropic support [ Time Frame: 1 minute after ICU admission ]
    number
  • incidence of atrial fibrillation [ Time Frame: 1 minute after ICU admission ]
    number
  • partial pressure of oxygen [ Time Frame: 1 minute after insertion of arterial cannula ]
    by mmhg in arterial blood gases
  • partial pressure of oxygen [ Time Frame: 1 minute after extubation ]
    by mmhg in arterial blood gases
  • partial pressure of oxygen [ Time Frame: 6 hour after extubation ]
    by mmhg in arterial blood gases
  • partial pressure of oxygen [ Time Frame: 12 hour after extubation ]
    by mmhg in arterial blood gases
  • incidence of cerebral stroke [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number
  • incidence of cerebral bleeding [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number
  • Gastrointestinal bleeding [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number
  • blood component requirements [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number
  • incidence of sternal complications. [ Time Frame: 1 minute after ICU admission up to 2 days ]
    number
  • hospital stay [ Time Frame: 1 minute after ICU admission up to 2 days ]
    in days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 18, 2019)
  • Age [ Time Frame: 2 hours before operation ]
    in years
  • body mass index [ Time Frame: 2 hours before operation ]
    kilogram/square meter
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries
Official Title  ICMJE The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain After Open Heart Surgeries
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.
Detailed Description

Pain following cardiac surgery is caused by many factors; sternotomy, chest wall retraction, opening of the pericardium, internal mammarian artery harvesting, saphenous vein harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma occurring during surgery.

The pain following cardiac surgery is mainly attributed to sternotomy, with its peak during the first two days after the operation. Poststernotomy pain is not well tolerated by patients and may be accompanied by adverse postoperative events including delirium, hypertension, tachycardia, arrhythmia, respiratory complications, and persistent postsurgical pain.

Commonly pain management after cardiac surgery has been achieved using opiate analgesics. However, opiates have some dose-related side-effects such as nausea, constipation, vomiting, dizziness, mental confusion and respiratory depression, which may influence patient recovery and may delay discharge after surgery.

The pecto-intercostal fascial block (PIFB) was recently introduced by de la Torre et al for anesthesia during breast surgery. Local anesthetic is infiltrated into the interfascial plane separating pectoralis major and the intercostal muscles lateral to the sternum to anesthetize the anterior cutaneous branches of the intercostal nerves.

The pecto-intercostal fascial plane block can cover anterior branches of the intercostal nerves from the 2nd to 6th dermatomes with a single injection bilaterally, same as the transversus thoracic muscle plane block .

anesthetic management: All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, renal and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested in patients prepared for CABG.

Patient will be premedicated by intramuscular injection of 10mg morphine in the morning of the operation. Before induction of anesthesia, a five‐lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. General anesthesia will be induced by midazolam 2-5 mg, fentanyl (10 μg/kg), propofol (3-4mg/Kg), followed by atracurium (0.5 mg/kg).

Trachea will be intubated, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. This will be confirmed by radial arterial blood gas analysis. An esophageal temperature probe and a Foley catheter will also be placed.

For drug infusion, a triple‐lumen central venous catheter will be inserted via the right internal jugular vein.

Anesthesia will be maintained by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h for continued muscle relaxation. During extracorporeal circulation, patients will receive propofol infusion at a rate of 100-200 mg/h in addition to atracurium infusion.

Before initiation of cardiopulmonary bypass (CPB), the patients will receive intravenously tranexamic acid (2 g) and heparin (300-500 units/kg body weight) to achieve an activated clotting time > 480 s. CPB will be instituted via an ascending aortic cannula and a two‐stage right atrial cannula. Before, during, and after CPB (pump blood flow: 2.4 l/min/m2), mean arterial pressure will be adjusted to exceed 60 mmHg. Cardiac arrest will be induced with cold antegrade blood cardioplegia or warm intermittent antegrade crystalloid cardioplegia. Lactate‐enriched Ringer's solution will be added to the CPB circuit to maintain reservoir volume when needed, and packed red blood cells will be added when hemoglobin concentration decrease to less than 7 g/dl.

After rewarming the patient to 37°C and separation from CPB, reversal of heparin by protamine sulfate (1:1), and sternal closure will be achieved.

All patients then will be shifted to the intensive care unit (ICU) after the surgery and managed with the institution's ICU protocol for postoperative pain management and ventilation. The postoperative analgesia protocol involves the use of intravenous morphine or morphine equivalent dose of 5to 10 mg/kg bolus as required. Criteria for administration will be signs of sympathetic stimulation in the form of undue tachycardia, a rise in mean arterial pressure (rise of >20% from the baseline).

Tracheal extubation will be performed when the patient met the following criteria: awake/arousable, hemodynamically stable, no active bleeding, warm peripheries, and satisfactory arterial blood gas with an FiO2 < 0.5,pressure support on ventilator reduced to 10 Cm H2O,Positive End Expiratory Pressure 5-7 CmH2O, no electrolyte abnormalities, minimal inotropic support, or no escalation in inotropic support.

Statistical analysis Sample size was calculated using (G power version 3). Minimal sample size of patients was 31 in each group needed to get power level 0.90, alpha level 0.05 and 30% as a difference between the two groups in the morphine consumption after the intervention. To overcome problem of loss of follow up, calculated sample size was increased by 10% to reach 35 in each group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pain, Chest
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Device: ultrasound
    • Drug: Bupivacaine Hydrochloride 5 MG/ML
  • No Intervention: control group
    the block will not be given
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alyaa A Hassan, MSc 01091169956 ext +2 aam17@fayoum.edu.eg
Contact: Hany M Yassin, MD 01111363602 ext +2 hmy00@fayoum.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04134637
Other Study ID Numbers  ICMJE D178
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed Ahmed Hamed, Fayoum University Hospital
Study Sponsor  ICMJE Fayoum University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Maged L Boules, MD Faculty of medicine, Fayoum university
Study Director: Mohamed A Hamed, MD Faculty of medicine, Fayoum university
PRS Account Fayoum University Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP