The aim of this study is to compare the analgesic efficacy when intravenous lignocaine is used as adjuvant analgesia in burn patients during change of dressing under general anesthesia
Design
Two arm single blinded parallel group randomized controlled trial
Settings and conduct
This randomized controlled trial was carried out at the Department of Anesthesiology, Combined Military Hospital from Jan-Jun 2023. Participants were single blinded by using non-descript marked burettes one containing ligonicaine and one containing normal saline (placebo) prepared before the start of surgery. patients were not told about the preparation details.
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA status patients presenting to the operating room for change of dressing under general anesthesia for full thickness burns (extending all dermal layers including bone, tissues, and ligaments).
Exclusion criteria included patients with metastatic disease, major cardiac or respiratory disease, low ejection fraction, post chemotherapy, pregnant females, patients with partial thickness burns and unwilling to be included in the study
Intervention groups
The patients were divided into two groups after randomization in Group L (n=45) as the intravenous lignocaine group and Group A (n=45) as the non-adjuvant group without intravenous lignocaine.
Main outcome variables
Primary variables measured were mean heart rate, systolic and diastolic blood pressure, and oxygen saturation 5 minutes post-intubation and 15 minutes into the procedure and median pain scores 1-hour post-extubation in the recovery on standardized Visual Analog Scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230816059169N1
Registration date:2023-09-11, 1402/06/20
Registration timing:retrospective
Last update:2023-09-11, 1402/06/20
Update count:0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Muhammad Zaheer Ud din
Name of organization / entity
College of physcian and surgeons Pakistan
Country
Pakistan
Phone
+92 333 4319191
Email address
xaheertiwana@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-01-01, 1401/10/11
Actual recruitment end date
2023-06-30, 1402/04/09
Trial completion date
2023-06-30, 1402/04/09
Scientific title
EFFICACY OF INTRAVENOUS LIGNOCAINE AS ADJUVANT ANALGESIA IN BURN PATIENTS DURING CHANGE OF DRESSING UNDER GENERAL ANESTHESIA
Public title
LIGNOCAINE AS ANALGESIA IN BURN PATIENTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All ASA status patients presenting to the operating room for change of dressing under general anesthesia for full thickness burns
Exclusion criteria:
Patient with metastatic disease, post chemotherapy
Major cardiac or respiratory disease
Patients with partial thickness burns
Those unwilling to be included in the study
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were divided into two groups after randomization in Group L (n=45) as the intravenous lignocaine group and Group A (n=45) as the non-adjuvant group without intravenous lignocaine. The method of randomization was non-probability consecutive sampling via lottery method. All the patients were thoroughly counselled regarding the procedure and in case the patients were unable to communicate, permission was taken from the next of kin. An informed written high-risk consent was taken for surgery.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in the study were briefed about the study protocol or how the results would be analyzed. 100 ml burettes containing the pre-mixed drug dose of lignocaine and one containing only normal saline were used to prevent observer bias.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ERB Combined Military Hospital Rawalpindi (CMH RWP)
Street address
CMH RWP
City
Rawalpindi
Postal code
46000
Approval date
2022-12-20, 1401/09/29
Ethics committee reference number
447
Health conditions studied
1
Description of health condition studied
Burns
ICD-10 code
T30.0
ICD-10 code description
Burn of unspecified body region, unspecified degree
Primary outcomes
1
Description
Mean heart rate, blood pressure and oxygen saturation
Timepoint
Pre-induction, 5 min and 30 minutes into procedure
Method of measurement
Standard cardiac monitor
2
Description
Median pain scores on standardized Visual Analog Scale
Timepoint
1-hour post-extubation in the recovery
Method of measurement
Standard Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group L (Intravenous lignocaine) Patients in Group L received intravenous lignocaine at a dose of 1.5 mg/kg infused over 5 minutes before induction whereas patient in Group A only received intravenous paracetamol and nalbuphine. Anesthesia was induced with intravenous propofol at 1.5 mg/kg, paralysis was achieved with atracurium 0.5 mg/kg and anesthesia was maintained with inhalational isoflurane at 1 MAC (minimum alveolar concentration)
Category
Treatment - Drugs
2
Description
Control group: Group A (Normal saline group) is the non-adjuvant group without intravenous lignocaine
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH RWP
Full name of responsible person
Dr Muhammad Zaheer ud din
Street address
CMH RWP
City
Rawalpindi
Postal code
46000
Phone
+92 333 4319191
Email
xaheertiwana@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Rawalpindi
Full name of responsible person
Dr Muhammad Zaheer ud din
Street address
CMH RWP
City
Rawalpindi
Postal code
46000
Phone
+92 333 4319191
Email
xaheertiwana@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Rawalpindi
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
CMH Rawalpindi
Full name of responsible person
Dr Muhammad Zaheer ud din
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH RWP
City
Rawalpindi
Province
punjab
Postal code
46000
Phone
+92 333 4319191
Email
xaheertiwana@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Rawalpindi
Full name of responsible person
Dr Muhammad Zaheer ud din
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH RWP
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 4319191
Email
xaheertiwana@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Rawalpindi
Full name of responsible person
Dr Muhammad Zaheer ud din
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH RWP
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 4319191
Email
xaheertiwana@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data collected included the Primary variables ie heart rate, systolic and diastolic blood pressure, and oxygen saturation 5 minutes post-intubation and 15 minutes into the procedure and median pain scores 1-hour post-extubation in the recovery on standardized Visual Analog Scale
When the data will become available and for how long
After approval from the primary author
To whom data/document is available
Public
Under which criteria data/document could be used
Study purpose
From where data/document is obtainable
the data would be available via email after contacting primary author ,email address is xaheertiwana@gmail.com
What processes are involved for a request to access data/document
An email would be sent to the primary author for data sharing request and once approved a link would be given to download the data.All this process would require around 7 days