NCT04116554

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

Completed Phase 4 Last updated 2 February 2021

What this trial tests

Phase 4 trial testing 0.25% bupivacaine. in Analgesia in 70 participants. Completed in 1 February 2021.

Timeline

27 December 2019

Primary endpoint
31 January 2021

1 February 2021

Quick facts

Lead sponsor	Fayoum University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	27 December 2019
Primary completion	31 January 2021
Estimated completion	1 February 2021
Sites	1 location across Egypt

Drugs / interventions tested

• 0.25% bupivacaine.
• 0.9%saline

Conditions studied

• Analgesia — all drugs for Analgesia →

Sponsor

Fayoum University

Who can join

18 and older, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Analgesic Efficacy of Ultrasound-Guided Bilateral Transversus Thoracic Muscle Plane Block After Open-Heart Surgeries: A Randomized Controlled Study.
   Hamed MA, Boules ML, Sobhy MM, Abdelhady MA. · · 2022 · cited 19× · PMID 35281480 · DOI 10.2147/jpr.s355231
2. The Analgesic Efficacy of Ultrasound-guided Bilateral Transversus Thoracic MusclePlane Block after Open-Heart Surgeries: A Randomized Controlled Study
   Hamed MA, Boules ML, Sobhy MM, Abdelhady MA. · · 2021 · DOI 10.21203/rs.3.rs-955344/v1