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

October 14, 2024 updated by: Hatice AZİZOĞLU, Yuzuncu Yıl University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After open heart surgery, patients experience high levels of pain at the sternotomy incision site and around the chest tube(s), affecting their recovery. This study was conducted to determine the effects of local anesthetic application around the sternotomy incision site and chest tube(s) on the amount of opioids used and recovery after surgery in patients undergoing open heart surgery. The study population consisted of patients who underwent open heart surgery in the Cardiovascular Surgery Intensive Care Unit of a hospital. The sample group consisted of patients who met the inclusion criteria (patients between 18 and 65 years of age, conscious, and willing to communicate and cooperate after open heart surgery). For the planned study, the "G. Power-3.1.9.2" program was used to calculate the sample size at an 80% confidence level prior to data collection. The sample was determined with the "Sample Calculation Formula (n=Nz2pq / d2(N-1) + z2pq). According to the literature review, it was determined that the "effect size value was 0.096". Accordingly, with a primary type error of 5% (Z = 1.96), a test power of 80%, and an effect size of 0.096 units, the minimum sample size was calculated as n = 60. Thus, of the 60 volunteer patients included in the study, 30 were randomly assigned to the experimental group and 30 to the control group. Data were collected using a Descriptive Characteristics Form and the Postoperative Recovery Index (PoRI).

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. SPSS 19.0 (SPSS Inc., Chicago, Illinois, USA) package program was used for data evaluation. Descriptive statistics for continuous variables were expressed as mean and standard deviation, while descriptive statistics for categorical variables were expressed as number and percentage. Normality of data distribution was tested by Kolmogorov-Smirnov, and homogeneity of variances was tested by Levene's test. In independent two-group comparisons in terms of continuous variables, the Independent Groups T-test was used in cases where normal distribution conditions were met, and Mann-Whitney U test statistics were used in cases where normal distribution conditions were not met. In independent comparisons of more than two groups in terms of continuous variables, one-way analysis of variance (ANOVA) was used in cases where normal distribution conditions were met, and Kruskal-Wallis test statistics were used in cases where normal distribution conditions were not met. The Spearman rank correlation coefficient was calculated between groups to determine the relationship between continuous variables. All test data were evaluated at a 95% confidence interval and a 0.05 significance level.

Research Hypotheses

H0: In patients undergoing open heart surgery, local anesthetic application around the sternotomy incision site and chest tube(s) has no effect on the amount of postoperative opioid use and recovery.

H1: In patients undergoing open heart surgery, local anesthetic application around the sternotomy incision site and chest tube(s) has an effect on the amount of postoperative opioid use and recovery.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey
        • Yuzuncu Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients between 18 and 65 years of age, and willing to communicate and cooperate after open heart surgery

Exclusion Criteria:

  • Patients younger than 18 years and older than 65 years, unwilling to communicate and cooperate, sensitive to local anaesthetics and not willing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL GROUP
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 Postoperative Recovery Index (PoRI) was recorded.
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.
Other Names:
  • Application of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml to the sternotomy incision area and around the drains
No Intervention: CONTROL GROUP
No intervention was performed on 30 patients in the control group, and standard treatment and care continued to be applied to these patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Opioid Consumed in the Postoperative Period
Time Frame: First 24 hours after open heart surgery
After open heart surgery, 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 compared with the control group.
First 24 hours after open heart surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Principal Investigator: Hatice Azizoğlu, Yuzuncu Yıl University
  • Study Chair: Mehmet Aşam, Van Training and Research Hospital
  • Study Chair: Zeynep Gürkan, Yuzuncu Yıl University
  • Study Chair: Yasemin Bozkurt, Van Training and Research Hospital
  • Study Chair: Canan Demir, Yuzuncu Yıl University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

October 13, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/19-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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