CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Single-injection, ultrasound-guided bilateral PIF block. +1 moreprocedure
Likely dose
Not stated in 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/NCT04791592
NCT04791592N/ACompleted

Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Acute Post-sternotomy Pain After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study

Ondokuz Mayıs University·interventional·Posted Mar 10, 2021·Updated Apr 23, 2021

In Brief

A clinical study evaluating Single-injection, ultrasound-guided bilateral PIF block. and Single-injection, ultrasound-guided bilateral TTMP block. for Pain, Postoperative and Coronary Artery Disease. Completed, enrolled 42 participants across 1 site.

Detailed Summary

In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 10, 2021
Enrollment StartMar 12, 2021
Primary CompletionApr 14, 2021
Study CompletionApr 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 5.3 years ago

Interventions

Single-injection, ultrasound-guided bilateral PIF block.procedure

PIF block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.

Single-injection, ultrasound-guided bilateral TTMP block.procedure

TTMP block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.