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Trial registered on ANZCTR


Registration number
ACTRN12619001168145p
Ethics application status
Submitted, not yet approved
Date submitted
8/07/2019
Date registered
20/08/2019
Date last updated
20/08/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of post-operative Lidocaine Infusion on GastroIntestinal Tract function in patients undergoing laparoscopic colorectal resections
Scientific title
Randomised control trial assessing impact of 24-hr post-operative lidocaine infusion vs placebo on return of gastrointestinal function in adults undergoing elective laparoscopic colorectal resections.
Secondary ID [1] 298672 0
Nil known
Universal Trial Number (UTN)
U1111-1236-6747
Trial acronym
LIGIT TRIAL
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Postoperative Ileus 313573 0
Condition category
Condition code
Surgery 312005 312005 0 0
Other surgery
Oral and Gastrointestinal 312071 312071 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention of this study is the administration of 24 hours of postoperative lidocaine intravenous continuous drip infusion at a rate of 1mg/kg/hr. Made up by pharmacy and administered by an experienced anesthetist. The infusion will be set up and placed in a locked and secured box to avoid accidental tampering.
The infusion will continue as originally set up until the completion of the 24 hour infusion.

Intraoperative lidocaine infusions are now standard practice for colorectal resections at Austin hospital and therefore this will be administered to both exposure and placebo group during the study period. This will be run at a standard rate of 1.5mg/kg intraoperatively.

At the completion of the case but before extubation, the patient will then be allocated to lidocaine or placebo. In the intervention arm, the lidocaine infusion will run at 1mg/kg/hr for 24 hours. The infusion will be setup immediately at the completion of surgery prior to extubation and continue to run until 24 hours later.
Intervention code [1] 314944 0
Treatment: Drugs
Comparator / control treatment
In the control arm, a 'placebo' drug of Normal Saline will run at an infusion rate equivalent of that of the lidocaine infusion (eg 60kg with a lidocaine concentration of 20mg/ml = 3ml/hr) and therefore the saline infusion would run at 3ml/hour for 24 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 320650 0
Return of Gastrointestinal Function - a composite outcome of: Time of first bowel motion and/or first flatus AND tolerating a solid meal
Designed specifically for this study.
Timepoint [1] 320650 0
Timepoint is the duration to return of gastrointestinal function this is checked every 2 hours by nursing staff, however the patient is also given a bowel function questionnaire and they are asked to complete this at the time of passage of flatus, bowel motion and tolerating solid diet.
These are checked daily and will continue to be checked daily until all three components have been completed. This will ususally be completed within 4 days from surgery
Secondary outcome [1] 372321 0
Incidence of post-operative ileus (POI) as defined by:
Presence of 2/4 on post operative day 4
Nasuea + vomiting
Requirement of nasogastric tube
Abscence of flatus or bowel motion
Radiological findings consistent with this (abdominal xray showing dilated loops of bowel).

This is a dichotomous outcome assessed at day 4 from clinical notes, radiological findings and ward rounds.
Timepoint [1] 372321 0
This will be assessed once daily until discharge.
Secondary outcome [2] 372322 0
Assessed by documentation in clinical notes of time pt is ready for discharge
Timepoint [2] 372322 0
At Discharge.
Secondary outcome [3] 372323 0
Pain scores as measured by validated visual analogue scale
Timepoint [3] 372323 0
2 hrly until 120 hours postoperative
Secondary outcome [4] 372324 0
Oral opiate requirement equivalent (inclusive of IV or oral administration) determined by documenttion in medical records - total opiate consumption will be converted into oral morphine equivelance.
Timepoint [4] 372324 0
Assessed once daily until discharge
Secondary outcome [5] 372325 0
Complications
Lidocaine related adverse outcomes
Minor – peri-oral tingling, tinitis, ECG changes related to IV lidocaine
Severe – Seizures, ECG changes, arrhythmia
*Assessed by educated nursing staff as per lidocaine infusion protocol/clinical note

All other complications as per Clavian-Dindo classification.
Timepoint [5] 372325 0
Assessed every 2 hours during admission until discharge and then a single phone call at 30 days post-discharge to determine any additional complicaitons

Eligibility
Key inclusion criteria
INCLUSION CRITERIA
All patients >18 years undergoing elective laparoscopic/hybrid colorectal resections for benign or malignant conditions at Austin hospital during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to IV lidocaine:
• Known history of allergy or hypersensitivity to Lidocaine (lignocaine) or other amide-type local anaesthetic.
• Stokes-Adams syndrome or any type of heart block or other high-risk arrhythmias.
• Severe shock
• Myasthenia gravis
• Serious diseases of the CNS or of the spinal cord

Other exclusion criteria:
• Childs Pugh A or worse liver disease
• CKD with eGFR <40ml/hr
• Chronic use of opioid analgesia or local anesthetics
• Patients will be excluded if they were unable to participate in postoperative assessments because of language difficulty, postoperative confusion, or cognitive impairment.

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 will be concealed in a sealed envelope until the time of set up of the study drug. The drug will already have been prepared by the pharmacy department and will be coded as to whether it is active or placebo, therefore, the anesthetist setting up the infusion will have no knowledge as to whether the patient will be in the active or placebo group. At the time of inclusion into the study, the study participant and recruiter will not know which group the participant will be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis was performed using STATA version 14.2 for Windows (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP).
We used the composite measure of time to tolerating solid diet and passage of flatus OR bowel motion as the primary endpoint of our study (GI-3).
With respect to our composite primary endpoint of return of gastrointestinal function (GI-3), sample size analysis using the z test for two independent means revealed a required number of patients of 25 per group to detect a 10 hour difference, with a two-tailed of 0.05 and power of 80 %.
We used the results of a recently published meta-analysis (reference here) that had a mean time to first bowel movement of 61.6 hours and SD of 12.4 hours in the control group and a difference of 7.9 hours between groups for our estimation.
The same meta-analysis also demonstrated that time to first flatus was achieved before first bowel motion, therefore the greater of these two measures (time to first bowel motion) was used to meet the sample size requirement for our composite primary outcome. The total number of patients per group was increased to 28 to compensate for possible dropouts.
The normality of study endpoint distributions was assessed graphically and with the Shapiro-Wilk test.
Normally distributed continuous variables were reported as mean and standard deviation (SD) and analysed using Student’s t test.
Non-normally distributed data were reported as the median and inter-quartile range (IQR) and analysed using the Mann–Whitney U-test.
Categorical characteristics were summed as n (%) and analysed using a chi-square or Fisher’s exact test, as appropriate.
Postoperative pain scores and cumulative opioid use were compared between the groups at all time intervals postoperatively. Differences for these measures were assessed using repeated-measures analysis of variance.

All statistical tests were two-tailed at a significance level of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14155 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 27125 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303212 0
Hospital
Name [1] 303212 0
Austin Hospital
Country [1] 303212 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Shine
Address
Austin Hospital
145 Studley Road,
Heidelberg
3084
VIC
Country
Australia
Secondary sponsor category [1] 303229 0
None
Name [1] 303229 0
NA
Address [1] 303229 0
NA
Country [1] 303229 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303769 0
Austin Health Ethics Committee
Ethics committee address [1] 303769 0
Ethics committee country [1] 303769 0
Australia
Date submitted for ethics approval [1] 303769 0
25/07/2019
Approval date [1] 303769 0
Ethics approval number [1] 303769 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94734 0
Dr Rebecca Shine
Address 94734 0
Austin Hospital
145 Studley Road,
Heidelberg
3084
VIC
Country 94734 0
Australia
Phone 94734 0
+61 418667600
Fax 94734 0
Email 94734 0
rshi027@gmail.com
Contact person for public queries
Name 94735 0
Rebecca Shine
Address 94735 0
Austin Hospital
145 Studley Road,
Heidelberg
3084
VIC
Country 94735 0
Australia
Phone 94735 0
+61 418667600
Fax 94735 0
Email 94735 0
rshi027@gmail.com
Contact person for scientific queries
Name 94736 0
Rebecca Shine
Address 94736 0
Austin Hospital
145 Studley Road,
Heidelberg
3084
VIC
Country 94736 0
Australia
Phone 94736 0
+61 418667600
Fax 94736 0
Email 94736 0
rshi027@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2921Study protocol  rshi027@gmail.com 377919-(Uploaded-08-07-2019-20-26-02)-Study-related document.docx



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.