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Completed

NCT Number: NCT04134637

Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum university hospital

Al Fayyum, 63512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

in the PIFB group linear ultrasound (Philips clear vue350,Philips healthcare,Andover MAO1810,USA,Machine Identification number:1385,Nile medical center,[email protected]) probe will be used.

Bupivacaine Hydrochloride 5 MG/ML

Drug

twenty milliliters of a solution of 0.25% bupivacaine in the PIFB group

Other names: sunnypivacaine

Primary outcomes

  1. Cumulative morphine consumption

    Time frame: 24 hours postoperative

    in milligram

Secondary outcomes

  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 outcomes

  1. Age

    Time frame: 2 hours before operation

    in years

  2. body mass index

    Time frame: 2 hours before operation

    kilogram/square meter

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain After Open Heart Surgeries

Acronym: PIFB

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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