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Pain, ChestPIFBNCT04134637

Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries

A study testing ultrasound and Bupivacaine Hydrochloride 5 MG/ML in people with Pain, Chest, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Chest
What is being tested?
ultrasound and Bupivacaine Hydrochloride 5 MG/ML
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
1 Oct 2019to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum university hospital

    Al Fayyum, 63512

Other trials in Egypt

About this study

Official title: The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain 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.

Read the 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.

Conditions
Pain, Chest
Being tested
ultrasound, Bupivacaine Hydrochloride 5 MG/ML
Keywords
pecto intercostal fascial plane block, sternotomy
Medical subject headings
Chest Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasoundDevice

    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.

  • Bupivacaine Hydrochloride 5 MG/MLDrug

    Also called sunnypivacaine

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

Study groups in NCT04134637
Study groupRoleWhat they receive
PIFB groupExperimentalFor 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.
Receives: Device: ultrasound; Drug: Bupivacaine Hydrochloride 5 MG/ML
control groupNo interventionthe block will not be given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative morphine consumption

    in milligram

    Measured: 24 hours postoperative

Secondary outcomes (28)
  1. 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

    Measured: 4 hours after extubation

  2. 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

    Measured: 8 hours after extubation

  3. 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

    Measured: 12 hours after extubation

  4. 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

    Measured: 16 hours after extubation

  5. 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

    Measured: 20 hours after extubation

  6. 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

    Measured: 24 hours after extubation

  7. Heart rate

    in beat per minute

    Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times

  8. systolic blood pressure

    in millimeter mercury

    Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times

  9. diastolic blood pressure

    in millimeter mercury

    Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times

  10. peripheral oxygen saturation

    in percentage by pulse oximetry

    Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times

  11. heart rate

    in beat per minute

    Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times

  12. systolic blood pressure

    in millimeter mercury

    Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times

  13. diastolic blood pressure

    in millimeter mercury

    Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times

  14. peripheral oxygen saturation

    in percentage by pulse oximetry

    Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times

  15. incidence of Myocardial infarction

    number

    Measured: 1 minute after ICU admission

  16. incidence of postoperative pericardial effusion

    number

    Measured: 1 minute after ICU admission

  17. incidence of heart failure requiring inotropic support

    number

    Measured: 1 minute after ICU admission

  18. incidence of atrial fibrillation

    number

    Measured: 1 minute after ICU admission

  19. partial pressure of oxygen

    by mmhg in arterial blood gases

    Measured: 1 minute after insertion of arterial cannula

  20. partial pressure of oxygen

    by mmhg in arterial blood gases

    Measured: 1 minute after extubation

  21. partial pressure of oxygen

    by mmhg in arterial blood gases

    Measured: 6 hour after extubation

  22. partial pressure of oxygen

    by mmhg in arterial blood gases

    Measured: 12 hour after extubation

  23. incidence of cerebral stroke

    number

    Measured: 1 minute after ICU admission up to 2 days

  24. incidence of cerebral bleeding

    number

    Measured: 1 minute after ICU admission up to 2 days

  25. Gastrointestinal bleeding

    number

    Measured: 1 minute after ICU admission up to 2 days

  26. blood component requirements

    number

    Measured: 1 minute after ICU admission up to 2 days

  27. incidence of sternal complications.

    number

    Measured: 1 minute after ICU admission up to 2 days

  28. hospital stay

    in days

    Measured: 1 minute after ICU admission up to 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2019
  2. Study start1 Oct 2019
  3. Primary completion1 Nov 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04134637
Sponsor's protocol ID
D178
Acronym
PIFB
Status last verified
Dec 2020
First submitted
12 Jul 2019
Last updated
19 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25796483
  • 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.

    PubMed 21955825
  • 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.

    PubMed 22156268
  • 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.

    PubMed 27776103
  • 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.

    PubMed 27325411

Questions about this trial

What is this clinical trial studying?

A study testing ultrasound and Bupivacaine Hydrochloride 5 MG/ML in people with Pain, Chest, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative morphine consumption (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04134637, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.

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