Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries

NCT04134637 | Completed

• 1 other identifier: D178
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chest

Keywords

pecto intercostal fascial plane block; sternotomy

Outcome Measures

Primary Outcomes (1)

• Cumulative morphine consumption

  in milligram

  24 hours postoperative

Secondary Outcomes (28)

• postoperative sternal wound pain degree

  4 hours after extubation

• postoperative sternal wound pain degree

  8 hours after extubation

• postoperative sternal wound pain degree

  12 hours after extubation

• postoperative sternal wound pain degree

  16 hours after extubation

• postoperative sternal wound pain degree

  20 hours after extubation

Other Outcomes (2)

• Age

  2 hours before operation

• body mass index

  2 hours before operation

Study Arms (2)

PIFB group

EXPERIMENTAL

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; Drug: Bupivacaine Hydrochloride 5 MG/ML

control group

NO INTERVENTION

the block will not be given

Interventions

ultrasound DEVICE

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.

PIFB group

Bupivacaine Hydrochloride 5 MG/ML DRUG

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

Also known as: sunnypivacaine

PIFB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum university hospital

Al Fayyum, 63512, Egypt

Location

Related Publications (5)

• 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.

  PMID: 25796483 BACKGROUND

• 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.

  PMID: 21955825 BACKGROUND

• 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.

  PMID: 22156268 BACKGROUND

• 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.

  PMID: 27776103 BACKGROUND

• 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.

  PMID: 27325411 BACKGROUND

MeSH Terms

Conditions

Chest Pain

Interventions

Ultrasonography; Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Maged L Boules, MD

  Faculty of medicine, Fayoum university

  STUDY CHAIR

• Mohamed A Hamed, MD

  Faculty of medicine, Fayoum university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: October 22, 2019
• Study Start: October 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)