Clinical Trial Results:
A comparison between continuous systemic Lidocain and patient controlled intravenous morphine administration for pain control after posterior spinal fusion (PSF) in adolescent idiopatic scoliosis (AIS)
Summary
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EudraCT number |
2012-005264-98 |
Trial protocol |
BE |
Global end of trial date |
12 Aug 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 |
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 |
GDW112012
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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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,
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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 |
12 Dec 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Aug 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Aug 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 peri- and postoperative administration of lidocaine an effective traetment to reduce postoperative pain after scoliosis surgery of Adolescent idiopathic scoliosis.
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Protection of trial subjects |
The study medication was administered to patients with default hemodynamic monitoring in the setting of a completely equipped operation theatre. This enabled immediate detection and management of potential adverse events. Administration of study drugs was to be immediately stopped in case that the study subject 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.
Postoperative pain and distress was monitored and treated as described in the protocol. The Visual Analogue Scale (VAS) was used to assess pain and adequate pain treatment was provided.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Mar 2013
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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: 70
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Worldwide total number of subjects |
70
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EEA total number of subjects |
70
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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) |
28
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Adults (18-64 years) |
34
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
140 patients were assessed for eligibilty, 70 patients were enrolled and randomized between September 2013 and July 2015. | |||||||||
Pre-assignment
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Screening details |
70 patients scheduled for posterior arthrodesis were enrolled in this prospective, randomised, double-blind, placebo-controlled clinical trial placebo group n=34 (1 patient partial loss of follow up) lidocaine group n=35 | |||||||||
Pre-assignment period milestones
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Number of subjects started |
70 | |||||||||
Number of subjects completed |
70 | |||||||||
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 | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Lidocaine-group | |||||||||
Arm description |
- | |||||||||
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 drip use
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Dosage and administration details |
Patients in the lidocaine-group were given an intravenous (IV) bolus injection of lidocaine 1.5 mg/kg at induction of anaesthesia and then a continuous infusion of 1.5 mg/kg.h which was continued until 6 hours after arrival at the PACU (postoperative care unit).
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Arm title
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Placebo-group | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
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 bolus use , Intravenous drip use
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Dosage and administration details |
Patients in the placebo-group were given an intravenous (IV) bolus injection of saline at induction of anaesthesia and then a continuous infusion which was continued until 6 hours after arrival at the PACU.
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Baseline characteristics reporting groups
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Reporting group title |
Lidocaine-group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo-group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lidocaine-group
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Reporting group description |
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Reporting group title |
Placebo-group
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Reporting group description |
- |
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End point title |
Cumulative morphine usage | ||||||||||||
End point description |
Total usage of morphine during the first 24 hours postoperatively
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End point type |
Primary
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End point timeframe |
24 hours after surgery
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Statistical analysis title |
Mean cumulative morphine usage | ||||||||||||
Comparison groups |
Lidocaine-group v Placebo-group
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Number of subjects included in analysis |
70
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.215 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Postoperative nausea and vomiting | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day of surgery, day 1,2 and 3 after surgery
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Statistical analysis title |
Occurance of postoperative nausea and vomiting | |||||||||||||||
Comparison groups |
Lidocaine-group v Placebo-group
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||||||||
P-value |
= 0.805 | |||||||||||||||
Method |
Fisher exact | |||||||||||||||
Confidence interval |
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End point title |
Total number of morphine boli | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At removal of PCIA system
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Statistical analysis title |
Demanded boli | ||||||||||||||||||
Comparison groups |
Placebo-group v Lidocaine-group
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Number of subjects included in analysis |
70
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||||
P-value |
= 0.47 | ||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Until day 3 after surgery
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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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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Reporting group title |
Placebo-group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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30 May 2013 |
Pharmocokinetic sampling for lidocaine |
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09 Jul 2013 |
Quality of life questionnaire (SF-12) during screening and one month after surgery. |
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17 Dec 2013 |
Study participant age from 18 - 75 years.
Incorportation of ECG pre-operative, at arrival PACU and 24hr postoperatively (Safety measurement). |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/28403408 |