Clinical Trial Results:
Randomized, double-blind, prospective, placebo-controlled trial of the effect of intravenous lidocaine infusion for postoperative pain management and bowel function in robot assisted laparoscopic colon surgery.
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Summary
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EudraCT number |
2014-003466-25 |
Trial protocol |
DK |
Global end of trial date |
31 May 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Jul 2018
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First version publication date |
13 Jul 2018
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Other versions |
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Summary report(s) |
Randomized, double-blind, prospective, placebo-controlled trial of the effect of intravenous lidocaine infusion for postoperative pain management and bowel function in robot assisted laparoscopic colo |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
13.024
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Anders Gadegaard Jensen,Anesthesia and Intensive Care Unit, Odense University Hospital
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Sponsor organisation address |
Søndre Boulevard 29, odense, Denmark, 5000
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Public contact |
Jan Herzog, Jan Herzog,Anesthesia and Intensive Care Unit, Odense University Hospital, 0045 60709164, anders.gadegaard.jensen@rsyd.dk
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Scientific contact |
Jan Herzog, Jan Herzog,Anesthesia and Intensive Care Unit, Odense University Hospital, 0045 60709164, anders.gadegaard.jensen@rsyd.dk
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Sponsor organisation name |
Anders Gadegaard Jensen,Anesthesia and Intensive Care Unit, Odense University Hospital
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Sponsor organisation address |
Søndre Boulevard 29, Odense C, Denmark, 5000
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Public contact |
Anders Gadegaard Jensen,
Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., Anders Gadegaard Jensen,
Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., 0045 65413758, anders.gadegaard.jensen@rsyd.dk
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Scientific contact |
Anders Gadegaard Jensen,
Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., Anders Gadegaard Jensen,
Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., 0045 65413758, anders.gadegaard.jensen@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
25 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 May 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
31 May 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main purpose of the trial is to investigate whether intravenous lidocaine administered perioperatively can significantly reduce postoperative morphine consumption during the first 24 hours postoperatively by robot-assisted laparoscopic colon rectal cancer surgery.
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Protection of trial subjects |
The trial participant is carefully observed during the per- and postoperative course with regard to adverse events and events both in the operating room by the anesthetic staff and in the recovery section by the staff here. If any adverse event were observed in this period, they were recorded.Procedures for recording and reporting events / adverse events:
Definitions of events and side effects were divided into the following:
Event: Any unwanted incident in a clinical trial after a drug with a patient or a subject without the need for a correlation between this and the unwanted event.
Adverse Drug Reaction (ADR): Any adverse and undesired reaction to a trial drug regardless of dose.
Unexpected adverse reaction: A side effect, whose grade or seriousness does not match the product information (product summary).
Severe Incidence (SAE) or serious adverse event (SAR): An event or adverse event irrespective of dose results in death, is life threatening, causes hospitalization or prolonged hospitalization, resulting in significant or sustained disability or incapacity or leads to congenital anomaly or malformation.
Unexpected and suspected serious side effects (SUSAR): suspected adverse reactions that are both unexpected and severe.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
10
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From 65 to 84 years |
40
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85 years and over |
10
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Recruitment
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Recruitment details |
We included adult, Danish speaking patients scheduled for elective robot-assisted laparoscopic colorectal surgery. Exclusion criteria were: allergy for amide localanalgetics, atrioventricular blocks, hepatic- (ALAT, ASAT or bilirubin > 2,5 x upper limit), or renal failure (calculated CrCl<60ml/min), chronic use of opioids or NSAID'S, pregnant or la | |||||||||
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Pre-assignment
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Screening details |
We included adult, Danish speaking patients scheduled for elective robot-assisted laparoscopic colorectal surgery. Exclusion criteria were: allergy for amide localanalgetics, atrioventricular blocks, hepatic- (ALAT, ASAT or bilirubin > 2,5 x upper limit), or renal failure (calculated CrCl<60ml/min), chronic use of opioids or NSAID'S, pregnant or la | |||||||||
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Period 1
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Period 1 title |
Randomized, double-blind, prospective, p (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
lidocaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Before anesthesia induction we gave an equal volume of blinded study medication according to 1,5mg/kg bolus from a solution of 0,5% lidocaine with a rate of 300ml/h. Thereafter we started the continuing infusion of the same volume per hour throughout the surgery ending in the PACU 2 hours after end of surgery. A 70kg patient would get 21ml study medication (either isotonic saline or 0,5% lidocaine) as a bolus and 21ml/h until 2 hours after end of surgery.
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Arm title
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placebo | |||||||||
Arm description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
hypotonic saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Before anesthesia induction we gave an equal volume of blinded study medication according to 1,5mg/kg bolus from a solution of 0,5% lidocaine with a rate of 300ml/h. Thereafter we started the continuing infusion of the same volume per hour throughout the surgery ending in the PACU 2 hours after end of surgery. A 70kg patient would get 21ml study medication (either isotonic saline or 0,5% lidocaine) as a bolus and 21ml/h until 2 hours after end of surgery
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Baseline characteristics reporting groups
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Reporting group title |
Randomized, double-blind, prospective, p
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
We randomized 60 patients in this prospective, randomized, dou
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline. The follow up period was 72 hours. Primary outcome was cumulative morphine consumption at 24 hours. Secondary outcomes were cumulative morphine consumption at 72hours, numerical pain score at 24 hours/72hours, length of stay, incidence of use of antiemetics, time until flatus/defecation.
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline. | ||
Reporting group title |
placebo
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Reporting group description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline | ||
Subject analysis set title |
We randomized 60 patients in this prospective, randomized, dou
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline. The follow up period was 72 hours. Primary outcome was cumulative morphine consumption at 24 hours. Secondary outcomes were cumulative morphine consumption at 72hours, numerical pain score at 24 hours/72hours, length of stay, incidence of use of antiemetics, time until flatus/defecation.
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End point title |
The primary outcome | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The primary outcome was cumulative morphine consumption at 24hrs after end of surgery.
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Statistical analysis title |
The primary outcome | ||||||||||||||||
Comparison groups |
Intervention v placebo
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Number of subjects included in analysis |
60
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Analysis specification |
Post-hoc
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Analysis type |
other [1] | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Regression, Linear | ||||||||||||||||
Confidence interval |
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| Notes [1] - Power calculation was done in advance assuming 30% reduction in morphine consumption (based on prior studies by other groups) in the lidocaine group. We needed a power of 80% to detect a difference defined by a p<0,05. According to this calculation we needed 49 patients and decided to include 60 considering there might be dropouts. The data was analyzed according to the intention-to-treat principle. |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From arriving to the operating theatre until 72 hours after conclusion the surgery.
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Assessment type |
Systematic | |||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
GCP | |||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline. | |||||||||||||||
Reporting group title |
placebo
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Reporting group description |
We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: We did not register any non-serious adverse event in the intervention group. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
