CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
0.25% bupivacaine. +1 moredrug
Likely dose
0.9%salinefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04116554
NCT04116554Phase 4Completed

Efficacy of Ultrasound-guided Bilateral Transversus Thoracic Muscle Plane Block as Postoperative Analgesia in Adult Patients Undergoing Open Heart Surgeries: a Randomized Controlled Study.

Fayoum University·interventional·Posted Oct 4, 2019·Updated Feb 2, 2021

In Brief

A Phase 4 clinical trial evaluating 0.25% bupivacaine. and 0.9%saline for Analgesia. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnalgesia
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedOct 4, 2019
Enrollment StartDec 27, 2019
Primary CompletionJan 31, 2021
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.7 years ago

Interventions

0.25% bupivacaine.drug

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

0.9%salinedevice

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