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

Primary Purpose

Pain, Chest

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound
Bupivacaine Hydrochloride 5 MG/ML
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Chest focused on measuring pecto intercostal fascial plane block, sternotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fayoum university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PIFB group

control group

Arm Description

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.

the block will not be given

Outcomes

Primary Outcome Measures

Cumulative morphine consumption
in milligram

Secondary Outcome Measures

postoperative sternal wound pain degree
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
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
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
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
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
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
in beat per minute
systolic blood pressure
in millimeter mercury
diastolic blood pressure
in millimeter mercury
peripheral oxygen saturation
in percentage by pulse oximetry
heart rate
in beat per minute
systolic blood pressure
in millimeter mercury
diastolic blood pressure
in millimeter mercury
peripheral oxygen saturation
in percentage by pulse oximetry
incidence of Myocardial infarction
number
incidence of postoperative pericardial effusion
number
incidence of heart failure requiring inotropic support
number
incidence of atrial fibrillation
number
partial pressure of oxygen
by mmhg in arterial blood gases
partial pressure of oxygen
by mmhg in arterial blood gases
partial pressure of oxygen
by mmhg in arterial blood gases
partial pressure of oxygen
by mmhg in arterial blood gases
incidence of cerebral stroke
number
incidence of cerebral bleeding
number
Gastrointestinal bleeding
number
blood component requirements
number
incidence of sternal complications.
number
hospital stay
in days

Full Information

First Posted
July 12, 2019
Last Updated
December 16, 2020
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04134637
Brief Title
Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries
Acronym
PIFB
Official Title
The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain After Open Heart Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chest
Keywords
pecto intercostal fascial plane block, sternotomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIFB group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
the block will not be given
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 5 MG/ML
Other Intervention Name(s)
sunnypivacaine
Intervention Description
twenty milliliters of a solution of 0.25% bupivacaine in the PIFB group
Primary Outcome Measure Information:
Title
Cumulative morphine consumption
Description
in milligram
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
postoperative sternal wound pain degree
Description
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
Time Frame
4 hours after extubation
Title
postoperative sternal wound pain degree
Description
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
Time Frame
8 hours after extubation
Title
postoperative sternal wound pain degree
Description
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
Time Frame
12 hours after extubation
Title
postoperative sternal wound pain degree
Description
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
Time Frame
16 hours after extubation
Title
postoperative sternal wound pain degree
Description
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
Time Frame
20 hours after extubation
Title
postoperative sternal wound pain degree
Description
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
Time Frame
24 hours after extubation
Title
Heart rate
Description
in beat per minute
Time Frame
1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
Title
systolic blood pressure
Description
in millimeter mercury
Time Frame
1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
Title
diastolic blood pressure
Description
in millimeter mercury
Time Frame
1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
Title
peripheral oxygen saturation
Description
in percentage by pulse oximetry
Time Frame
1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
Title
heart rate
Description
in beat per minute
Time Frame
1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
Title
systolic blood pressure
Description
in millimeter mercury
Time Frame
1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
Title
diastolic blood pressure
Description
in millimeter mercury
Time Frame
1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
Title
peripheral oxygen saturation
Description
in percentage by pulse oximetry
Time Frame
1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
Title
incidence of Myocardial infarction
Description
number
Time Frame
1 minute after ICU admission
Title
incidence of postoperative pericardial effusion
Description
number
Time Frame
1 minute after ICU admission
Title
incidence of heart failure requiring inotropic support
Description
number
Time Frame
1 minute after ICU admission
Title
incidence of atrial fibrillation
Description
number
Time Frame
1 minute after ICU admission
Title
partial pressure of oxygen
Description
by mmhg in arterial blood gases
Time Frame
1 minute after insertion of arterial cannula
Title
partial pressure of oxygen
Description
by mmhg in arterial blood gases
Time Frame
1 minute after extubation
Title
partial pressure of oxygen
Description
by mmhg in arterial blood gases
Time Frame
6 hour after extubation
Title
partial pressure of oxygen
Description
by mmhg in arterial blood gases
Time Frame
12 hour after extubation
Title
incidence of cerebral stroke
Description
number
Time Frame
1 minute after ICU admission up to 2 days
Title
incidence of cerebral bleeding
Description
number
Time Frame
1 minute after ICU admission up to 2 days
Title
Gastrointestinal bleeding
Description
number
Time Frame
1 minute after ICU admission up to 2 days
Title
blood component requirements
Description
number
Time Frame
1 minute after ICU admission up to 2 days
Title
incidence of sternal complications.
Description
number
Time Frame
1 minute after ICU admission up to 2 days
Title
hospital stay
Description
in days
Time Frame
1 minute after ICU admission up to 2 days
Other Pre-specified Outcome Measures:
Title
Age
Description
in years
Time Frame
2 hours before operation
Title
body mass index
Description
kilogram/square meter
Time Frame
2 hours before operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maged L Boules, MD
Organizational Affiliation
Faculty of medicine, Fayoum university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed A Hamed, MD
Organizational Affiliation
Faculty of medicine, Fayoum university
Official's Role
Study Director
Facility Information:
Facility Name
Fayoum university hospital
City
Fayoum
ZIP/Postal Code
63512
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25796483
Citation
Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
Results Reference
background
PubMed Identifier
21955825
Citation
Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
Results Reference
background
PubMed Identifier
22156268
Citation
Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
Results Reference
background
PubMed Identifier
27776103
Citation
Del Buono R, Costa F, Agro FE. Parasternal, Pecto-intercostal, Pecs, and Transverse Thoracic Muscle Plane Blocks: A Rose by Any Other Name Would Smell as Sweet. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):791-792. doi: 10.1097/AAP.0000000000000464. No abstract available.
Results Reference
background
PubMed Identifier
27325411
Citation
Ohgoshi Y, Ino K, Matsukawa M. Ultrasound-guided parasternal intercostal nerve block. J Anesth. 2016 Oct;30(5):916. doi: 10.1007/s00540-016-2202-5. Epub 2016 Jun 20. No abstract available.
Results Reference
background

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Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries

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