Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642077
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Opioid Use of Local Anaesthetic Agents in Open Heart Surgery and Its Effect on Recovery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Local Anaesthetic Agents on Opioid Use and Recovery in Patients Undergoing Open Heart Surgery A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 tubes 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 tubes accelerate postoperative recovery
In this study LIDOFAST 40 mg2 ml 0025 mg2 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
In patients undergoing open heart surgery does the application of local anesthetic around the sternotomy incision site and chest tubes 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 tubes accelerate postoperative recovery
In this study LIDOFAST 40 mg2 ml 0025 mg2 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
Detailed Description:
After open heart surgery patients experience high levels of pain at the sternotomy incision site and around the chest tubes affecting their recovery This study was conducted to determine the effects of local anesthetic application around the sternotomy incision site and chest tubes 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-3192 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 nNz2pq d2N-1 z2pq According to the literature review it was determined that the effect size value was 0096 Accordingly with a primary type error of 5 Z 196 a test power of 80 and an effect size of 0096 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 mg2 ml 0025 mg2 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 mg2 ml 0025 mg2 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 190 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 Levenes 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 005 significance level
Research Hypotheses
H0 In patients undergoing open heart surgery local anesthetic application around the sternotomy incision site and chest tubes 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 tubes has an effect on the amount of postoperative opioid use and recovery
A total of 2 ampoules of LIDOFAST 40 mg2 ml 0025 mg2 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 mg2 ml 0025 mg2 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 190 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 Levenes 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 005 significance level
Research Hypotheses
H0 In patients undergoing open heart surgery local anesthetic application around the sternotomy incision site and chest tubes 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 tubes has an effect on the amount of postoperative opioid use and recovery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None