Trial Review

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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
Scientific title
Comparison of the analgesic effect of acetaminophen, morphine and lidocaine for postoperative pain following cardiopulmonary bypass grafting
Secondary ID [1] 304751 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain after cardiopulmonary bypass graft 322793 0
Condition category
Condition code
Anaesthesiology 320385 320385 0 0
Pain management
Cardiovascular 321567 321567 0 0
Other cardiovascular diseases
Surgery 321568 321568 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 321131 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 328295 0
The degree of pain at rest
Pain assessment was done with visual analogue scale (VAS), face to face. Every patient was constantly monitored
Timepoint [1] 328295 0
0min, 30min, 1h, 2h, 4h (primary endpoint)
8h, 12h, 24h and 48h post-operatively
Primary outcome [2] 329333 0
The degree of pain during movement
Pain assessment was done with visual analogue scale (VAS), face to face, Every patient was constantly monitored
Timepoint [2] 329333 0
8h ,12h, 24h, (primary endpoint)
48h post operatively

Secondary outcome [1] 398428 0
The degree of pain during coughing
Pain during coughing assessed using visual analogue scale (VAS)
Timepoint [1] 398428 0

8h,12h,24h,48h post operative.
Secondary outcome [2] 402169 0
Requirement for opioids for postoperative pain management assessed using patient medical record
Timepoint [2] 402169 0
4h, 8h, 12h and 24 hours post-operative

Eligibility
Key inclusion criteria
All the patient planed for elective cardiopulmonary bypass surgery,
ASA classification (American Society of Anesthesiologists ) II-IV
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
25/11/2019
Date of last participant enrolment
Anticipated
Actual
30/04/2021
Date of last data collection
Anticipated
1/06/2022
Actual
2/05/2021
Sample size
Target
90
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 23974 0
Albania
State/province [1] 23974 0
Kosovo

Funding & Sponsors
Funding source category [1] 309125 0
Hospital
Name [1] 309125 0
University Clinical Center of Kosovo
Country [1] 309125 0
Albania
Primary sponsor type
Hospital
Name
University Clinical Center of Kosovo
Address
Street Muharrem Fejza, no number, Lagjja e spitalit Prishtine
Kosovo
10 0000
Country
Albania
Secondary sponsor category [1] 310072 0
None
Name [1] 310072 0
Address [1] 310072 0
Country [1] 310072 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 308990 0
Ethics committee address [1] 308990 0
Ethics committee country [1] 308990 0
Date submitted for ethics approval [1] 308990 0
Approval date [1] 308990 0
Ethics approval number [1] 308990 0

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
Trial website
Trial related presentations / publications
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

Contacts
Principal investigator
Name 112578 0
Dr Doruntina Bunjaku
Address 112578 0
Clinic of Anesthesiology and Intensive Care / University Clinical Center of Kosovo
Street Muharrem Fejza, no number, Lagjja e Spitalit
Prishtine , 10000
Kosovo
Country 112578 0
Albania
Phone 112578 0
+383 44 160 221
Fax 112578 0
Email 112578 0
doruntina.bunjaku@gmail.com
Contact person for public queries
Name 112579 0
Dr Doruntina Bunjaku
Address 112579 0
Clinic of Anesthesiology and Intensive Care / University Clinical Center of Kosovo
Street Muharrem Fejza, no number, Lagjja e Spitalit
Prishtine , 10000
Kosovo
Country 112579 0
Albania
Phone 112579 0
+384 44 160 221
Fax 112579 0
Email 112579 0
doruntina.bunjaku@gmail.com
Contact person for scientific queries
Name 112580 0
Prof Antigona Hasani
Address 112580 0
Spitali Amerikan
Street Rruga e Shkupit No 25
Prishtine 10000
Kosovo
Country 112580 0
Albania
Phone 112580 0
+383 44 402 781
Fax 112580 0
Email 112580 0
antigona.hasani.@uni-pr.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals
by Principal Investigator
doruntina.bunjaku@gmail.com


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.