Bilateral Transversus Thoracic Muscle Plane Block as Analgesic in Open Heart Surgeries by US.

NCT04116554 | Completed Phase 4

• 1 other identifier: D199
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

OPEN CARDIAC SURGERY may cause severe postoperative pain and promote a high risk of chronic pain if not treated adequately, that is caused by multiple factors; sternotomy, costotransverse and costovertebral joint distensions, opening of the pericardium, internal mammarian artery harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma that occurs during surgery. Adequate analgesia is important not only for patient comfort, but for weaning from ventilator and prevention of respiratory complications. Opioids are used to provide analgesia, but they are associated with significant side effects which include sedation, respiratory depression, nausea, and vomiting. Severe sternotomy pain in cardiac surgery has been reported in up to 49% of patients at rest and 78% at movement. Of the various options for postoperative pain relief in cardiac surgery, we have chosen an ultrasound-guided transversus thoracic muscle plane (TTP) block versus sham block performed by the anesthesiologist. Transversus thoracic muscle plane (TTP) block and The pecto-intercostal fascial plane block can block multiple anterior branches of the intercostal nerves (T2 to 6), which dominate the internal mammary region with a single injection bilaterally.

Conditions

Analgesia

Keywords

transversus thoracic muscle plane block.; analgesic after open heart surgery.

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  the amount of opioid (mostly used is fentanyl amp. in equivalent doses ) that has been used for 24 hours after admission in ICU

  from the time of ICU admission hour 1 up to 24 hour

Study Arms (2)

intervention group (A)

ACTIVE COMPARATOR

which will have an ultrasound-guided bilateral transversus thoracic muscle plane (TTP) block by injection of 20 mL of 0.25% bupivacaine and the same procedure will be repeated on the other side.

Drug: 0.25% bupivacaine.

control group (B)

SHAM COMPARATOR

which will have sham block bilaterally by injection of 20 ml of 0.9%saline will be injected on each side.

Device: 0.9%saline

Interventions

0.25% bupivacaine. DRUG

20 mL of 0.25% bupivacaine and the same procedure will be repeated on the other side

Also known as: plain marcaine

intervention group (A)

0.9%saline DEVICE

20 ml of 0.9%saline will be injected on each side

control group (B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older (18 - 80 yrs. old).
• Scheduled for elective cardiac surgery for valve replacement or adult congenital (VSD or ASD) via median sternotomy.

You may not qualify if:

• Patients with emergency surgeries.
• Allergy to drug used.
• re-do surgery.
• Coagulopathy.
• Neuromuscular disease.
• Preoperative poor left ventricular function (EF \< 35%).
• Systemic infections or infections at site of injection.
• Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
• Narcotic dependency.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, 63511, Egypt

Location

Related Publications (3)

• Bignami E, Castella A, Allegri M. Postoperative Pain After Cardiac Surgery: An Open Issue. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):e24-e25. doi: 10.1053/j.jvca.2017.09.022. Epub 2017 Sep 20. No abstract available.

  PMID: 29217242 BACKGROUND

• Landoni G, Isella F, Greco M, Zangrillo A, Royse CF. Benefits and risks of epidural analgesia in cardiac surgery. Br J Anaesth. 2015 Jul;115(1):25-32. doi: 10.1093/bja/aev201.

  PMID: 26089444 BACKGROUND

• Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.

  PMID: 17006079 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• mohamed hamed, MD

  Fayoum University

  PRINCIPAL INVESTIGATOR

• Mahdy ahmed, MD

  Fayoum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: December 27, 2019
• Primary Completion: January 31, 2021
• Study Completion: February 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)