ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Anaesthesiology

Pain management

Cardiovascular

Other cardiovascular diseases

Surgery

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]

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]

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]

0min, 30min, 1h, 2h, 4h (primary endpoint) 8h, 12h, 24h and 48h post-operatively

Primary outcome [2]

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]

8h ,12h, 24h, (primary endpoint) 48h post operatively

Secondary outcome [1]

The degree of pain during coughing Pain during coughing assessed using visual analogue scale (VAS)

Timepoint [1]

8h,12h,24h,48h post operative.

Secondary outcome [2]

Requirement for opioids for postoperative pain management assessed using patient medical record

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Albania

State/province [1]

Kosovo

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

University Clinical Center of Kosovo

Address [1]

Street Muharrem Fejza, no number, Lagjja e spitalit Prishtine Kosovo 10 0000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Dr Doruntina Bunjaku

Address

Clinic of Anesthesiology and Intensive Care / University Clinical Center of Kosovo Street Muharrem Fejza, no number, Lagjja e Spitalit Prishtine , 10000 Kosovo

Country

Albania

Phone

+383 44 160 221

Fax

[email protected]

Contact person for public queries

Name

Doruntina Bunjaku

Address

Clinic of Anesthesiology and Intensive Care / University Clinical Center of Kosovo Street Muharrem Fejza, no number, Lagjja e Spitalit Prishtine , 10000 Kosovo

Country

Albania

Phone

+384 44 160 221

Fax

[email protected]

Contact person for scientific queries

Name

Antigona Hasani

Address

Spitali Amerikan Street Rruga e Shkupit No 25 Prishtine 10000 Kosovo

Country

Albania

Phone

+383 44 402 781

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?

• individual participant data underlying published results only

What types of analyses could be done with individual participant data?

• any purpose

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• access subject to approvals
by Principal Investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			Basic results summary.docx
Plain language summary	No		Pain management after cardiac surgery was performe... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically