CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
LIDOFAST 40 mg/2 ml + 0.025 mg/2 mldrug
Likely dose
LIDOFAST 40 mg/2 ml + 0.025 mg/2 mlfrom 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/NCT06642077
NCT06642077N/ACompleted

The Effect of Local Anaesthetic Agents on Opioid Use and Recovery in Patients Undergoing Open Heart Surgery: A Randomized Controlled Study

Yuzuncu Yil University·interventional·Posted Oct 15, 2024·Updated Oct 15, 2024

In Brief

A clinical study evaluating LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml for Analgesics, Opioid and Anesthetics, Local. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The aim of this randomized controlled study was to investigate the effect of injecting local anesthetic agents into the sternotomy incision site and around the drains on the amount of opioids used in the postoperative period and the healing process. The main questions it aims to answer are: * In patients undergoing open heart surgery, does the application of local anesthetic around the sternotomy incision site and chest tube(s) reduce the amount of postoperative opioid use? * In patients undergoing open heart surgery, does the application of local anesthetic around the sternotomy incision site and chest tube(s) accelerate postoperative recovery? In this study, LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml will be injected into the sternotomy incision area and around the drains of the patients in the experimental group, and the amount of opioid consumed in the postoperative period will be recorded and the healing process will be observed.

Study Details

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

Timeline

N/ACompletedFinished
202420252026
First PostedOct 15, 2024
Enrollment StartAug 1, 2023
Primary CompletionJan 15, 2024
Study CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 1.7 years ago

Interventions

LIDOFAST 40 mg/2 ml + 0.025 mg/2 mldrug

A total of 2 ampoules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml were injected into the sternotomy incision site and around the chest tubes of 30 patients in the experimental group. The total number and dose of opioids, the total number and dose of analgesics used to relieve the pain of the patients in the 24 hours after the injection of 2 ampules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml, and the total number and dose of analgesics were recorded, and the patients were interviewed face-to-face 24 hours later, and PoRI was recorded. No intervention was performed on 30 patients in the control group, and standard treatment and care continued to be applied to these patients.