Clinical Trial Results:
analgesia with continuous IV-infusion of lidocain during the perioperative period in patients undergoin laparoscopic sterilization.
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Summary
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EudraCT number |
2011-001315-31 |
Trial protocol |
BE |
Global end of trial date |
29 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jan 2020
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First version publication date |
01 Jan 2020
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Other versions |
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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 |
GD032011
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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 |
University Hospitals Leuven
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Sponsor organisation address |
herestraat, leuven, Belgium, 3001
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Public contact |
Anesthesia Research, University Hospitals Leuven, 32 16344620, christel.huygens@uzleuven.be
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Scientific contact |
Anesthesia Research, University Hospitals Leuven, 32 16344620, christel.huygens@uzleuven.be
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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 |
09 Sep 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 May 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
29 May 2015
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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 |
Is the perioperative IV administration of lidocaine an effective treatment to reduce postoperative pain after surgical sterilization.
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Protection of trial subjects |
The interventional treatment was administered to patients with standard hemodynamic monitoring in the setting of a fully equipped operation theatre. This enabled immediate detection and treatment of potential adverse events. Administration of study drugs was to be immediately stopped in case that the study participant showed signs of systemic toxicity (metallic taste, tinnitus, headache, seizure activity and ECG irregularities). Also after leaving the operation room, all patients were closely monitored for the occurrence of eventual (severe) adverse events.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Sep 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Belgium: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
80
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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) |
80
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
116 patients were assessed for eligibility, 80 patients were enrolled and randomized between November 2011 and may 2015 | |||||||||
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Pre-assignment
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Screening details |
80 women scheduled for laparoscopic sterilisation were included in this prospective, double-blind, randomised, placebo-controlled clinical trial. one patient was excluded from analysis because change of operation | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
80 | |||||||||
Number of subjects completed |
80 | |||||||||
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Period 1
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Period 1 title |
overall trial (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 | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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lidocaine | |||||||||
Arm description |
intravenously lidocaine | |||||||||
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 |
Solution for injection/infusion
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Routes of administration |
Intravenous bolus use , Intravenous use
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Dosage and administration details |
Patients in the L-group were given an intravenous (IV) bolus injection of lidocaine 1.5 mg∙kg 1 at induction of anesthesia followed by a continuous infusion of 1.5 mg∙kg-1∙h-1 which was continued until 30min after arrival at the PACU.
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Arm title
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placebo group | |||||||||
Arm description |
placebo | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous drip use , Intravenous bolus use
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Dosage and administration details |
Patients in the placrebo-group were given an intravenous (IV) bolus injection of saline at induction of anesthesia followed by a continuous infusion of salinewhich was continued until 30min after arrival at the PACU. Patients in the P-group were given equal volumes of saline.
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Baseline characteristics reporting groups
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Reporting group title |
lidocaine
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Reporting group description |
intravenously lidocaine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
placebo group
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Reporting group description |
placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
lidocaine
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Reporting group description |
intravenously lidocaine | ||
Reporting group title |
placebo group
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Reporting group description |
placebo | ||
Subject analysis set title |
a 2-sided test for the detection of differences between propor
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
lidocaine:40
placebo:40
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End point title |
proportion of patients with a NRS greater than 3 | |||||||||
End point description |
proportion of patients with NRS greater than 3
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End point type |
Primary
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End point timeframe |
30 min after arrival PACU
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Statistical analysis title |
2-sided test for the detection of differences betw | |||||||||
Comparison groups |
lidocaine v placebo group
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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level |
90% | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
from enrollment until discharge of the patient
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Assessment type |
Systematic | ||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
23
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Reporting groups
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Reporting group title |
lidocaine group
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Reporting group description |
- | ||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||
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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 | |||
