Opioid Use of Local Anaesthetic Agents in Open Heart Surgery and Its Effect on Recovery

NCT06642077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Analgesics, Opioid
  • Anesthetics, Local

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • Yuzuncu Yıl University

    lead OTHER

Principal Investigators

  • Hatice Azizoğlu · Yuzuncu Yıl University

  • Mehmet Aşam · Van Training and Research Hospital

  • Zeynep Gürkan · Yuzuncu Yıl University

  • Yasemin Bozkurt · Van Training and Research Hospital

  • Canan Demir · Yuzuncu Yıl University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-01-15
Completion
2024-03-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06642077 on ClinicalTrials.gov