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Trial registered on ANZCTR


Registration number
ACTRN12616000478415
Ethics application status
Approved
Date submitted
5/04/2016
Date registered
12/04/2016
Date last updated
12/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of 48-hour intravenous (IV) lidocaine infusions in open colorectal surgery.
Scientific title
Intravenous (IV) lidocaine infusions for 48 hours in open colorectal surgery: a prospective, randomised, double-blinded, placebo-controlled trial.
Secondary ID [1] 288935 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bowel cancer 298285 0
inflammatory bowel disease 298286 0
colorectal surgery 298287 0
Ileus 298321 0
Condition category
Condition code
Anaesthesiology 298419 298419 0 0
Pain management
Surgery 298443 298443 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing elective open colorectal surgery were randomised into the lidocaine group or control group.
The lidocaine group received 1.5 mg/kg i.v. bolus at induction of anaesthesia immediately followed by 1 mg/kg/hr i.v. infusion for a total of 48 hours duration.

On arrival at the post-anaesthesia care unit (PACU), all patients were connected to an i.v. fentanyl patient-controlled analgesia (PCA) pump (20 mcg bolus, 5 min lockout, maximum dose 240 mcg/hr). PCA fentanyl consumption and numerical pain rating scale (NRS, 0-10) at rest were recorded by a blinded non-study nurse at 30min, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours post-surgery. A blinded non-study pain physician monitored the patient daily, and adjusted the PCA dose if pain was not controlled.
Intervention code [1] 294406 0
Treatment: Drugs
Comparator / control treatment
Patients undergoing elective open colorectal surgery were randomised into the lidocaine group or control group.
The control group was administered intravenous saline infusion of equal volume to the lidocaine group. Patients were given a fentanyl opioid PCA for pain management.
Control group
Placebo

Outcomes
Primary outcome [1] 297897 0
Time to first bowel movement.
The nurse caring for the patient filled out a study-specific questionnaire form documenting time of return of first bowel movement and flatus, and adverse effects.
Timepoint [1] 297897 0
Time (hours) from arrival in the post-anaesthesia care unit (PACU).
Secondary outcome [1] 322568 0
Time to first flatus.
The nurse caring for the patient filled out a study-specific questionnaire form documenting time of return of first bowel movement and flatus, and adverse effects.
Timepoint [1] 322568 0
Time (hours) from arrival in the post-anaesthesia care unit (PACU).
Secondary outcome [2] 322569 0
Time to hospital discharge.
Duration was measured from time of beginning of surgical procedure, until the documented time of hospital discharge from the ward. This was measured by review of medical records. No specific tests were used.
Timepoint [2] 322569 0
Time (days) from the beginning of procedure.
Secondary outcome [3] 322570 0
Cumulative rest numerical rating scale pain scores (NRS, 0-10).
The nurse caring for the patient filled out a PCA study data form documenting the PCA opioid consumption and NRS pain scores.
Timepoint [3] 322570 0
NRS at rest were recorded by a blinded non-study nurse at 30min, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours post-surgery.
Secondary outcome [4] 322571 0
Cumulative opioid use.
The nurse caring for the patient filled out a PCA study data form documenting the PCA opioid consumption and NRS pain scores.
Timepoint [4] 322571 0
PCA opioid consumption (mcg fentanyl) was recorded by a blinded non-study nurse at 30min, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours post-surgery.
Secondary outcome [5] 322710 0
Adverse effects. Examples include: nausea, vomiting, itch, confusion, tremor, anxiety, and palpitations.
The nurse caring for the patient filled out a study-specific questionnaire form documenting time of return of first bowel movement and flatus, and adverse effects. No specific tools were used.
Timepoint [5] 322710 0
Adverse effects were documented by name and date/time. This was performed by the nurse caring for the patient, who assessed for adverse effects from the end of the procedure, every 4 hours up to 72 hours post procedure.

Eligibility
Key inclusion criteria
Patients aged 18-80 undergoing elective open colorectal surgery
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA classification status IV or above; liver cirrhosis; severe chronic renal impairment (serum creatinine > 200 umol L-1); pregnancy; cardiac conduction abnormalities; congestive heart failure; epilepsy; allergy to any of the study medications; opioid or alcohol abuse; and reported bowel movement frequencies greater than 3 per day, or less than 3 per week.

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)
The allocation sequence was concealed from the study team and kept in an opaque envelope in the locked possession of the in-charge operating room nurse (not otherwise involved in the study).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were allocated into two groups (lidocaine or control) by an independent statistician using a computer-generated randomisation number list in Microsoft Excel with a 1:1 ratio.
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
Placebo-controlled trial
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a difference in mean time to first bowel movement of 12 hours, a sample size of 28 patients in each group was calculated as sufficient, with 80% power at a two-tailed 5% significance level. This estimation was based on a meta-analysis (Sun et al. 2012) reporting a reduction in mean time to first bowel movement by 15.1 hours. Twenty-nine patients per group were enrolled to compensate for possible dropouts.
Statistical analysis was conducted with Stata 14 (Statacorp, College Station, TX, USA). The primary outcome measure was time to first bowel movement. Secondary outcome measures were time to first flatus, duration of hospital stay, pain scores, and cumulative opioid use up to 72 hours post-operatively. The Normality of study endpoint distributions were assessed graphically and with the Shapiro–Wilk test. Normally distributed variables were reported as mean (SD) and comparisons made by calculating the mean difference and 95%CI between the lidocaine and placebo arms. Non-normally distributed data were reported as the median and inter-quartile range (IQR) and analysed using the Wilcoxon test. Post-operative pain scores and cumulative opioid use were compared between treatment arms at 1, 4, 12, 24, 48, and 72 hours post-operatively. Categorical characteristics were summed as n (%), and analysed using a chi-square or Fisher’s exact test, as appropriate. A formal comparison of the post-operative pain scores over the total duration of follow-up was made with a generalised estimating equation (GEE).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2014
Date of last participant enrolment
Anticipated
Actual
22/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5550 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 5551 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 13023 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 293288 0
Hospital
Name [1] 293288 0
St Vincent's Hospital Sydney Department of Anaesthesia
Country [1] 293288 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney Department of Anaesthesia
Address
Level 4, Aikenhead Building, St Vincent's Hospital, 390 Victoria Street, Darlinghurst NSW, Australia 2010
Country
Australia
Secondary sponsor category [1] 292090 0
None
Name [1] 292090 0
Address [1] 292090 0
Country [1] 292090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294762 0
St Vincent's Hospital HREC
Ethics committee address [1] 294762 0
Ethics committee country [1] 294762 0
Australia
Date submitted for ethics approval [1] 294762 0
08/11/2012
Approval date [1] 294762 0
10/12/2013
Ethics approval number [1] 294762 0
HREC/12/SVH/297

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

Contacts
Principal investigator
Name 64962 0
Dr Matthew LJ Ho
Address 64962 0
St Vincent's Hospital Sydney
390 Victoria St
Darlinghurst NSW 2010
Australia
Country 64962 0
Australia
Phone 64962 0
+612 83823200
Fax 64962 0
+612 83823981
Email 64962 0
matthew.lj.ho@gmail.com
Contact person for public queries
Name 64963 0
Matthew LJ Ho
Address 64963 0
St Vincent's Hospital Sydney
390 Victoria St
Darlinghurst NSW 2010
Australia
Country 64963 0
Australia
Phone 64963 0
+612 83823200
Fax 64963 0
+612 83823981
Email 64963 0
matthew.lj.ho@gmail.com
Contact person for scientific queries
Name 64964 0
Matthew LJ Ho
Address 64964 0
St Vincent's Hospital Sydney
390 Victoria St
Darlinghurst NSW 2010
Australia
Country 64964 0
Australia
Phone 64964 0
+612 83823200
Fax 64964 0
+612 83823981
Email 64964 0
matthew.lj.ho@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntravenous lidocaine infusions for 48 hours in open colorectal surgery: A prospective, randomized, double-blinded, placebo-controlled trial.2018https://dx.doi.org/10.4097/kjae.2018.71.1.57
N.B. These documents automatically identified may not have been verified by the study sponsor.