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Trial registered on ANZCTR
Registration number
ACTRN12622000686707
Ethics application status
Not required
Date submitted
24/07/2021
Date registered
11/05/2022
Date last updated
11/05/2022
Date data sharing statement initially provided
11/05/2022
Date results information initially provided
11/05/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of the analgesic effect of acetaminophen, morphine and lidocaine for postoperative pain following cardiac surgery
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Scientific title
Comparison of the analgesic effect of acetaminophen, morphine and lidocaine for postoperative pain following cardiopulmonary bypass grafting
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Secondary ID [1]
304751
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain after cardiopulmonary bypass graft
322793
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Condition category
Condition code
Anaesthesiology
320385
320385
0
0
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Pain management
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Cardiovascular
321567
321567
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0
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Other cardiovascular diseases
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Surgery
321568
321568
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Post operative pain management after cardiac surgery.
The goal of the intervention is to reduce the intensity of pain.
Two groups are included in the study as control treatment, each group has 20 patients
Group 1(A) has received acetaminophen intravenous 1gr every 4 hour, for 48 hours post operative, starting immediately upon termination of anesthesia
Group 2 (M) received morphine intravenous 5mg every 6 hours, for 48 hours post operative, starting immediately upon termination of anesthesia
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Intervention code [1]
321131
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Treatment: Drugs
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Comparator / control treatment
Post operative pain management after cardiac surgery.
The goal of the intervention is to reduce the intensity of pain.
A group with 20 patients is as a comparator treatment group
Group 3 (L) has received Lidocaine intravenous 1.5mg/kg/h, continuous for 48 hours post operative,, starting immediately upon termination of anesthesia
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Control group
Active
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Outcomes
Primary outcome [1]
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The degree of pain at rest
Pain assessment was done with visual analogue scale (VAS), face to face. Every patient was constantly monitored
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Assessment method [1]
328295
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Timepoint [1]
328295
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0min, 30min, 1h, 2h, 4h (primary endpoint)
8h, 12h, 24h and 48h post-operatively
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Primary outcome [2]
329333
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The degree of pain during movement
Pain assessment was done with visual analogue scale (VAS), face to face, Every patient was constantly monitored
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Assessment method [2]
329333
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Timepoint [2]
329333
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8h ,12h, 24h, (primary endpoint)
48h post operatively
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Secondary outcome [1]
398428
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The degree of pain during coughing
Pain during coughing assessed using visual analogue scale (VAS)
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Assessment method [1]
398428
0
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Timepoint [1]
398428
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8h,12h,24h,48h post operative.
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Secondary outcome [2]
402169
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Requirement for opioids for postoperative pain management assessed using patient medical record
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Assessment method [2]
402169
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Timepoint [2]
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4h, 8h, 12h and 24 hours post-operative
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Eligibility
Key inclusion criteria
All the patient planed for elective cardiopulmonary bypass surgery,
ASA classification (American Society of Anesthesiologists ) II-IV
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
patient rejection,
unconscious patients,
patients taking chronically opioids
patient with renal insufficiency gr III-IV, hepatic insufficiency gr III-IV,
psychiatric patients,
patients allergy in acetaminophen, morphine or lidocaine respectively
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Numerical data will be processed by statistical methods and will be expressed as arithmetic mean, and standard deviation.
Statistical tests that will use are the Chi 2 (square) test to determine the difference between groups for categorical variables, two-way analysis of variance (ANOVA) for repeated measures, one-way analysis of variance (ANOVA) for group estimation, and determining the effect of time, and t2-test as well as other specific tests.
Statistical data will be processed through the SPSS statistical package.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
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Actual
25/11/2019
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Date of last participant enrolment
Anticipated
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Actual
30/04/2021
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Date of last data collection
Anticipated
1/06/2022
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Actual
2/05/2021
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Sample size
Target
90
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
23974
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Albania
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State/province [1]
23974
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Kosovo
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Funding & Sponsors
Funding source category [1]
309125
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Hospital
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Name [1]
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University Clinical Center of Kosovo
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Address [1]
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Street Muharrem Fejza, no number, Lagjja e spitalit Prishtine
Kosovo
10 0000
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Country [1]
309125
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Albania
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Primary sponsor type
Hospital
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Name
University Clinical Center of Kosovo
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Address
Street Muharrem Fejza, no number, Lagjja e spitalit Prishtine
Kosovo
10 0000
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Country
Albania
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Secondary sponsor category [1]
310072
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None
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Name [1]
310072
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Address [1]
310072
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Country [1]
310072
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Ethics approval
Ethics application status
Not required
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Ethics committee name [1]
308990
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Ethics committee address [1]
308990
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Ethics committee country [1]
308990
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Date submitted for ethics approval [1]
308990
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Approval date [1]
308990
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Ethics approval number [1]
308990
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Summary
Brief summary
The primary purpose of this study is to compare the analgesic effect of lidocaine in reducing intensity of pain in patient undergoing cardiac surgery, for coronary artery bypass graft .
The comparison was done with two other analgesics, acetaminophen and morphine , as a control treatment for reducing intensity of pain in patient undergoing cardiac surgery, for coronary artery bypass graft .
Intravenous administration of lidocaine provides a more satisfactory postoperative analgesia compared to the application of morphine and acetaminophen in the postoperative period
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Trial website
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Trial related presentations / publications
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Public notes
Ethics application status is not required because we use known and applicable drugs in the study
The drugs and doses that we use were safe. We compare analgesic effect of drugs already used
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Contacts
Principal investigator
Name
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Dr Doruntina Bunjaku
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Address
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Clinic of Anesthesiology and Intensive Care / University Clinical Center of Kosovo
Street Muharrem Fejza, no number, Lagjja e Spitalit
Prishtine , 10000
Kosovo
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Country
112578
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Albania
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Phone
112578
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+383 44 160 221
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Fax
112578
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Email
112578
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[email protected]
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Contact person for public queries
Name
112579
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Dr Doruntina Bunjaku
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Address
112579
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Clinic of Anesthesiology and Intensive Care / University Clinical Center of Kosovo
Street Muharrem Fejza, no number, Lagjja e Spitalit
Prishtine , 10000
Kosovo
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Country
112579
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Albania
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Phone
112579
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+384 44 160 221
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Fax
112579
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Email
112579
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[email protected]
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Contact person for scientific queries
Name
112580
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Prof Antigona Hasani
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Address
112580
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Spitali Amerikan
Street Rruga e Shkupit No 25
Prishtine 10000
Kosovo
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Country
112580
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Albania
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Phone
112580
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+383 44 402 781
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Fax
112580
0
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Email
112580
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
individual participant data underlying published results only
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
anyone who wishes to access it
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Available for what types of analyses?
any purpose
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How or where can data be obtained?
access subject to approvals
by Principal Investigator
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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