Analgesics, OpioidNCT06642077
Opioid Use of Local Anaesthetic Agents in Open Heart Surgery and Its Effect on Recovery
A study testing LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml in people with Analgesics, Opioid and Anesthetics, Local, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesics, Opioid, Anesthetics, Local
- What is being tested?
- LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 18 and 65 years of age, and willing to communicate and cooperate after open heart surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Analgesics, Opioid, Anesthetics, Local
- Being tested
- LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml
- Keywords
- Cardiovascular surgery, Pain management, Local anesthetics, Recovery after surgery, Opioids
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIDOFAST 40 mg/2 ml + 0.025 mg/2 mlDrug
Also called Application of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml to the sternotomy incision area and around the drains
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.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | 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. Receives: Drug: LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml |
| CONTROL GROUP | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Amount of Opioid Consumed in the Postoperative Period
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.
Measured: First 24 hours after open heart surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Aug 2023
- Primary completion15 Jan 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Analgesics, OpioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled experimental study was conducted with a total of 60 patients, with 30 patients in the experimental group and 30 patients in the control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice AZİZOĞLU, Yuzuncu Yil University
- Investigators
- Hatice Azizoğlu, Principal investigator, Yuzuncu Yil UniversityMehmet Aşam, Study chair, Van Training and Research HospitalZeynep Gürkan, Study chair, Yuzuncu Yil UniversityYasemin Bozkurt, Study chair, Van Training and Research HospitalCanan Demir, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642077
- Sponsor's protocol ID
- 2023/19-07
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Ebrahimi S, Paryad E, Ghanbari Khanghah A, Pasdaran A, Kazemnezhad Leili E, Sadeghi Meibodi AM. The effects of lavandula aromatherapy on pain relief after coronary artery bypass graft surgery: A randomized clinical trial. Appl Nurs Res. 2022 Dec;68:151638. doi: 10.1016/j.apnr.2022.151638. Epub 2022 Oct 28.
PubMed 36473717Choiniere M, Watt-Watson J, Victor JC, Baskett RJ, Bussieres JS, Carrier M, Cogan J, Costello J, Feindel C, Guertin MC, Racine M, Taillefer MC. Prevalence of and risk factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year prospective multicentre study. CMAJ. 2014 Apr 15;186(7):E213-23. doi: 10.1503/cmaj.131012. Epub 2014 Feb 24.
PubMed 24566643Cogan J. Pain management after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Sep;14(3):201-4. doi: 10.1177/1089253210378401.
PubMed 20705642White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.
PubMed 14508326Dowling R, Thielmeier K, Ghaly A, Barber D, Boice T, Dine A. Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1271-8. doi: 10.1016/s0022-5223(03)00585-3.
PubMed 14665996Golembiewski J. Local anesthetics. J Perianesth Nurs. 2013 Dec;28(6):409-12. doi: 10.1016/j.jopan.2013.09.001. No abstract available.
PubMed 24267631Shah J, Votta-Velis EG, Borgeat A. New local anesthetics. Best Pract Res Clin Anaesthesiol. 2018 Jun;32(2):179-185. doi: 10.1016/j.bpa.2018.06.010. Epub 2018 Jul 3.
PubMed 30322458Jannati M, Attar A. Analgesia and sedation post-coronary artery bypass graft surgery: a review of the literature. Ther Clin Risk Manag. 2019 Jun 20;15:773-781. doi: 10.2147/TCRM.S195267. eCollection 2019.
PubMed 31417264Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445.
PubMed 32584934Reisli R, Akkaya OT, Arican S, Can OS, Cetingok H, Gulec MS, Koknel Talu G. [Pharmachologic treatment of acute postoperative pain: A clinical practice guideline of The Turkish Society of Algology]. Agri. 2021 Jan;33(Suppl 1):1-51. doi: 10.14744/agri.2021.60243. Turkish.
PubMed 33523457Azizoglu H, Asam M, Gurkan Z, Bozkurt Y, Demir C. The effect of local anaesthetic agents on opioid use and recovery in patients undergoing open heart surgery: a randomized controlled study. BMC Cardiovasc Disord. 2025 Feb 1;25(1):72. doi: 10.1186/s12872-025-04493-2.
PubMed 39893373
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Anaesthetic Agents on Opioid Use and Recovery in Patients Undergoing Open Heart Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06642077
- Acronym / sponsor ID
- 2023/19-07
- Conditions
- Analgesics, Opioid, Anesthetics, Local
- Keywords
- Cardiovascular surgery, Pain management, Local anesthetics, Recovery after surgery, Opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled experimental study was conducted with a total of 60 patients, with 30 patients in the experimental group and 30 patients in the control group.
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Drug: LIDOFAST 40 mg/2 ml + 0.025 mg/2 mlA 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. |
| CONTROL GROUP | No intervention | –No intervention was performed on 30 patients in the control group, and standard treatment and care continued to be applied to these patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients between 18 and 65 years of age, and willing to communicate and cooperate after open heart surgery
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIDOFAST 40 mg/2 ml + 0.025 mg/2 mlAlso: Application of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml to the sternotomy incision area and around the drainsA 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. | Drug | EXPERIMENTAL GROUP |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Results publication: PubMed 36473717Ebrahimi S, Paryad E, Ghanbari Khanghah A, Pasdaran A, Kazemnezhad Leili E, Sadeghi Meibodi AM. The effects of lavandula aromatherapy on pain relief after coronary artery bypass graft surgery: A randomized clinical trial. Appl Nurs Res. 2022 Dec;68:151638. doi: 10.1016/j.apnr.2022.151638. Epub 2022 Oct 28.
- Results publication: PubMed 24566643Choiniere M, Watt-Watson J, Victor JC, Baskett RJ, Bussieres JS, Carrier M, Cogan J, Costello J, Feindel C, Guertin MC, Racine M, Taillefer MC. Prevalence of and risk factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year prospective multicentre study. CMAJ. 2014 Apr 15;186(7):E213-23. doi: 10.1503/cmaj.131012. Epub 2014 Feb 24.
- Results publication: PubMed 20705642Cogan J. Pain management after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Sep;14(3):201-4. doi: 10.1177/1089253210378401.
- Results publication: PubMed 14508326White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.
- Results publication: PubMed 14665996Dowling R, Thielmeier K, Ghaly A, Barber D, Boice T, Dine A. Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1271-8. doi: 10.1016/s0022-5223(03)00585-3.
- Results publication: PubMed 24267631Golembiewski J. Local anesthetics. J Perianesth Nurs. 2013 Dec;28(6):409-12. doi: 10.1016/j.jopan.2013.09.001. No abstract available.
- Results publication: PubMed 30322458Shah J, Votta-Velis EG, Borgeat A. New local anesthetics. Best Pract Res Clin Anaesthesiol. 2018 Jun;32(2):179-185. doi: 10.1016/j.bpa.2018.06.010. Epub 2018 Jul 3.
- Results publication: PubMed 31417264Jannati M, Attar A. Analgesia and sedation post-coronary artery bypass graft surgery: a review of the literature. Ther Clin Risk Manag. 2019 Jun 20;15:773-781. doi: 10.2147/TCRM.S195267. eCollection 2019.
- Results publication: PubMed 32584934Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445.
- Results publication: PubMed 33523457Reisli R, Akkaya OT, Arican S, Can OS, Cetingok H, Gulec MS, Koknel Talu G. [Pharmachologic treatment of acute postoperative pain: A clinical practice guideline of The Turkish Society of Algology]. Agri. 2021 Jan;33(Suppl 1):1-51. doi: 10.14744/agri.2021.60243. Turkish.
- Derived from this study: PubMed 39893373Azizoglu H, Asam M, Gurkan Z, Bozkurt Y, Demir C. The effect of local anaesthetic agents on opioid use and recovery in patients undergoing open heart surgery: a randomized controlled study. BMC Cardiovasc Disord. 2025 Feb 1;25(1):72. doi: 10.1186/s12872-025-04493-2.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice Azizoğlu principal investigator
Yuzuncu Yil University
Mehmet Aşam study chair
Van Training and Research Hospital
Zeynep Gürkan study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml in people with Analgesics, Opioid and Anesthetics, Local, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Opioid Consumed in the Postoperative Period (time frame: First 24 hours after open heart surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642077, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.