Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12618001335280
Ethics application status
Approved
Date submitted
29/07/2018
Date registered
8/08/2018
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Date results information initially provided
22/01/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
A prospective study to study the effect of intra-operative lidocaine 2% infusion in reducing intra-operative and postoperative opioid requirements for analgesia in patients undergoing renal transplantation surgery
Query!
Scientific title
the role of Intraoperative lidocaine 2% infusion in reducing postoperative fentanyl requirements for pain control during renal transplantation surgery
Query!
Secondary ID [1]
295686
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
postoperative pain
309053
0
Query!
patients undergoing renal transplantation
309054
0
Query!
chronic renal failure patients
309055
0
Query!
Condition category
Condition code
Renal and Urogenital
307942
307942
0
0
Query!
Other renal and urogenital disorders
Query!
Anaesthesiology
308024
308024
0
0
Query!
Pain management
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
50 Patients were randomly scheduled into 2 groups: Fentanyl (F) group and lidocaine (L) group, 25 patients in each group. The anesthetic techniques were standardized patients were pre medicated by midazolam 0.03mg/kg IV. Induction of anesthesia started by Propofol 2.5mg/kg IV, Fentanyl 3 ug/kg for the fentanyl group and 1.5 ug/kg for the lidocaine group with lidocaine 2% 1.5 mg/kg as loading dose followed by the maintenance dose of lidocaine 2% 2mg/kg/hr. Lidocaine infusion stopped with the beginning of skin closure. The primary outcome variable was the amount of fentanyl required in the PACU to establish and to maintain visual analogue scale pain scores < 4.
Query!
Intervention code [1]
302003
0
Treatment: Drugs
Query!
Comparator / control treatment
the control group will receive fentanyl 3 ug/kg with increments to maintain intraoperative analgesia
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
306914
0
postoperative fentanyl requirements for analgesia to keep the numerical pain score less than or equal to 4, the score will be assessed every 10 minutes by the recovery nurse and documented, with documentation of the intravenous fentanyl dose given by the anesthetist for the pain and the whole amount will be documented and calculated by the recovery nurse at the end of the hour.
Query!
Assessment method [1]
306914
0
Query!
Timepoint [1]
306914
0
first hour postoperative in the recovery, to keep numerical pain score less than or equal 4.
Query!
Primary outcome [2]
306997
0
patient controlled analgesia used by the patient.
Query!
Assessment method [2]
306997
0
Query!
Timepoint [2]
306997
0
the first 24 hours postoperative measured by amounts of demands to the amount of the supply.
Query!
Secondary outcome [1]
350089
0
Intraoperative Sevoflurane consumption to keep the patient anesthetized.
Query!
Assessment method [1]
350089
0
Query!
Timepoint [1]
350089
0
introperative sevoflurane MAC %
Query!
Secondary outcome [2]
350357
0
intraoperative opioid requirements to control intraoperative pain.
Query!
Assessment method [2]
350357
0
Query!
Timepoint [2]
350357
0
The surgical time: since induction of anesthesia until skin closure.
Query!
Eligibility
Key inclusion criteria
patients undergoing renal transplantation, age 16-70 years
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
liver cell failure, heart failure, chronic use of opioids, and allergy to the used medications either lidocaine 2% or fentanyl and inability to comprehended pain
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Data were collected, coded, tabulated, and then analyzed using SPSS® 16.0 statistical package. Variables were presented as mean and standard deviation, and analyzed using unpaired t-test. Any difference with p-value <0.05 was considered statistically significant. Sample size calculation revealed that at least 25 patients are needed in each group to detect a difference of at least 50mcg in the average consumption of opioid in the recovery, assuming that the standard deviation of this variable is 54.4 according to Seveine etal, 2008. With significant level of 0.05, and a power of 0.9.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
23/04/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
26/12/2018
Query!
Date of last data collection
Anticipated
Query!
Actual
29/12/2018
Query!
Sample size
Target
50
Query!
Accrual to date
Query!
Final
50
Query!
Recruitment outside Australia
Country [1]
10709
0
Saudi Arabia
Query!
State/province [1]
10709
0
king faisal specialized hospital , Jeddah branch
Query!
Funding & Sponsors
Funding source category [1]
300269
0
Hospital
Query!
Name [1]
300269
0
king Faisal specialized hospital
Query!
Address [1]
300269
0
Prince Saoud Alfaisal street, Alkhaldyia district, Jeddah, KSA
post code 21499
Query!
Country [1]
300269
0
Saudi Arabia
Query!
Primary sponsor type
Hospital
Query!
Name
king Faisal specialized hospital
Query!
Address
Prince Saoud Alfaisal street, Alkhaldyia district, Jeddah, KSA
postcode 21499
Query!
Country
Saudi Arabia
Query!
Secondary sponsor category [1]
299696
0
None
Query!
Name [1]
299696
0
none
Query!
Address [1]
299696
0
none
Query!
Country [1]
299696
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
301085
0
king faisal specialized hospital research centre
Query!
Ethics committee address [1]
301085
0
Prince Saoud Alfaisal street, Alkhaldyia district, Jeddah, KSA
Query!
Ethics committee country [1]
301085
0
Saudi Arabia
Query!
Date submitted for ethics approval [1]
301085
0
03/01/2018
Query!
Approval date [1]
301085
0
10/04/2018
Query!
Ethics approval number [1]
301085
0
Query!
Summary
Brief summary
Intraoperative lidocaine 2% infusion reduces intraoperative and postoperative opioid requirements for analgesia. Fifty patients were enrolled, the control group (n = 25) received fentanyl 3 µg/kg and lidocaine group received fentanyl 1.5 µg/kg and loading dose of lidocaine 2% 1.5 mg/kg loading with maintenance dose of lidocaine 2% infusion 2 mg/k/hr .
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Attachments [1]
2919
2919
0
0
/AnzctrAttachments/375693-lidocaine paper FINALIZING.docx
(Other)
Query!
Query!
Contacts
Principal investigator
Name
85830
0
Dr mostafa kamal abdellatif
Query!
Address
85830
0
king Fiasal specialized hospital, Alkaldhya district, Jeddah, KSA
post code 21499
Query!
Country
85830
0
Saudi Arabia
Query!
Phone
85830
0
+966504487096
Query!
Fax
85830
0
Query!
Email
85830
0
[email protected]
Query!
Contact person for public queries
Name
85831
0
Dr mostafa kamal asr
Query!
Address
85831
0
king Fiasal specialized hospital, Alkaldhya district, Jeddah, KSA
post code 21499
Query!
Country
85831
0
Saudi Arabia
Query!
Phone
85831
0
+966504487096
Query!
Fax
85831
0
Query!
Email
85831
0
[email protected]
Query!
Contact person for scientific queries
Name
85832
0
Dr mostafa asr
Query!
Address
85832
0
king Fiasal specialized hospital, Alkaldhya district, Jeddah, KSA
post code 21499
Query!
Country
85832
0
Saudi Arabia
Query!
Phone
85832
0
+966504487096
Query!
Fax
85832
0
Query!
Email
85832
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
results of the study tables
Query!
When will data be available (start and end dates)?
start date April 2018 till December 2018
Query!
Available to whom?
only researchers who provide a methodologically sound proposal,
Query!
Available for what types of analyses?
only to achieve the aims in the approved proposal
Query!
How or where can data be obtained?
access subject to approvals by Principal Investigator
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
2880
Plain language summary
No
1) Research question: will intraoperative infusion...
[
More Details
]
Documents added automatically
No additional documents have been identified.
Download to PDF