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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
Scientific title
the role of Intraoperative lidocaine 2% infusion in reducing postoperative fentanyl requirements for pain control during renal transplantation surgery
Secondary ID [1] 295686 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain 309053 0
patients undergoing renal transplantation 309054 0
chronic renal failure patients 309055 0
Condition category
Condition code
Renal and Urogenital 307942 307942 0 0
Other renal and urogenital disorders
Anaesthesiology 308024 308024 0 0
Pain management

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 302003 0
Treatment: Drugs
Comparator / control treatment
the control group will receive fentanyl 3 ug/kg with increments to maintain intraoperative analgesia
Control group
Active

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.

Timepoint [1] 306914 0
first hour postoperative in the recovery, to keep numerical pain score less than or equal 4.
Primary outcome [2] 306997 0
patient controlled analgesia used by the patient.
Timepoint [2] 306997 0
the first 24 hours postoperative measured by amounts of demands to the amount of the supply.
Secondary outcome [1] 350089 0
Intraoperative Sevoflurane consumption to keep the patient anesthetized.
Timepoint [1] 350089 0
introperative sevoflurane MAC %
Secondary outcome [2] 350357 0
intraoperative opioid requirements to control intraoperative pain.
Timepoint [2] 350357 0
The surgical time: since induction of anesthesia until skin closure.

Eligibility
Key inclusion criteria
patients undergoing renal transplantation, age 16-70 years
Minimum age
16 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10709 0
Saudi Arabia
State/province [1] 10709 0
king faisal specialized hospital , Jeddah branch

Funding & Sponsors
Funding source category [1] 300269 0
Hospital
Name [1] 300269 0
king Faisal specialized hospital
Address [1] 300269 0
Prince Saoud Alfaisal street, Alkhaldyia district, Jeddah, KSA
post code 21499
Country [1] 300269 0
Saudi Arabia
Primary sponsor type
Hospital
Name
king Faisal specialized hospital
Address
Prince Saoud Alfaisal street, Alkhaldyia district, Jeddah, KSA
postcode 21499
Country
Saudi Arabia
Secondary sponsor category [1] 299696 0
None
Name [1] 299696 0
none
Address [1] 299696 0
none
Country [1] 299696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301085 0
king faisal specialized hospital research centre
Ethics committee address [1] 301085 0
Prince Saoud Alfaisal street, Alkhaldyia district, Jeddah, KSA
Ethics committee country [1] 301085 0
Saudi Arabia
Date submitted for ethics approval [1] 301085 0
03/01/2018
Approval date [1] 301085 0
10/04/2018
Ethics approval number [1] 301085 0

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 .
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2919 2919 0 0

Contacts
Principal investigator
Name 85830 0
Dr mostafa kamal abdellatif
Address 85830 0
king Fiasal specialized hospital, Alkaldhya district, Jeddah, KSA
post code 21499
Country 85830 0
Saudi Arabia
Phone 85830 0
+966504487096
Fax 85830 0
Email 85830 0
mostafa_2041980@yahoo.com
Contact person for public queries
Name 85831 0
Dr mostafa kamal asr
Address 85831 0
king Fiasal specialized hospital, Alkaldhya district, Jeddah, KSA
post code 21499
Country 85831 0
Saudi Arabia
Phone 85831 0
+966504487096
Fax 85831 0
Email 85831 0
mostafa_2041980@yahoo.com
Contact person for scientific queries
Name 85832 0
Dr mostafa asr
Address 85832 0
king Fiasal specialized hospital, Alkaldhya district, Jeddah, KSA
post code 21499
Country 85832 0
Saudi Arabia
Phone 85832 0
+966504487096
Fax 85832 0
Email 85832 0
mostafa_2041980@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
results of the study tables
When will data be available (start and end dates)?
start date April 2018 till December 2018
Available to whom?
only researchers who provide a methodologically sound proposal,
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
Informed consent form
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
1) Research question: will intraoperative infusion of lidocaine 2% reduces the intraoperative and postoperative ovoid requirements?
2) Background information: Intravenous lidocaine has been shown to be analgesic and anti-inflammatory medication with modulation of excessive inflammatory response.
3) Participants characteristics: recipients for renal transplantation.
4) Key results: Both groups were comparable with regard to age and weight. The type and lengths of the surgical procedures were similar, there was no perioperative mortality. Intraoperative heart rate and mean blood pressure in the fentanyl group remained significantly higher statistically during the entire infusion period than that in the lidocaine group but within clinically acceptable range. During the recovery period, heart rate and Mean blood pressure showed higher levels in fentanyl group in comparison to lidocaine group with significant difference.The consumption of inhalational Sevoflurane gas was statically significance between the two groups.Intensity of pain assessed in the recovery unit, the mean pain numerical pain score in lidocaine group remained significantly less than that in the fentanyl group in the first hour.
5) Limitations: no limitations.