Clinical Trial Results:
Tumescent Anaesthesia in Endovenous Laser Ablation of Varicose Veins: A Randomised Controlled Trial of a Buffered Tumescent Solution
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Summary
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EudraCT number |
2011-005575-16 |
Trial protocol |
GB |
Global end of trial date |
26 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Dec 2019
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First version publication date |
18 Dec 2019
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Other versions |
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Summary report(s) |
A Randomised Clinical Trial of Buffered Tumescent Local Anaesthesia During Endothermal Ablation for Superficial Venous Incompetence |
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 |
BufferedTumescenceV4
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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 |
Hull University Teaching Hospitals NHS Trust
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Sponsor organisation address |
Anlaby Road, Hull, United Kingdom, HU3 2JZ
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Public contact |
Judith Long, Academic Vascular Surgical Unit, Hull Royal Infirmary, 01482 675784, judith.long@hey.nhs.uk
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Scientific contact |
Judith Long, Academic Vascular Surgical Unit, Hull Royal Infirmary, 01482 675784, judith.long@hey.nhs.uk
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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 |
29 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Jun 2014
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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 principle research objective is to determine whether the addition of sodium bicarbonate to tumescent anaesthesia results in less pain than conventional tumescent anaesthesia alone, when used during endovenous laser ablation of the Great Saphenous Vein.
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Protection of trial subjects |
A Patient information sheet was developed to explain in lay terms what is involved in the study. Participation was entirely voluntary and there are no specific side-effects associated with the use of Sodium Bicarbonate in this setting.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 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 |
United Kingdom: 97
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Worldwide total number of subjects |
97
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EEA total number of subjects |
97
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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) |
83
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From 65 to 84 years |
12
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85 years and over |
2
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Recruitment
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Recruitment details |
All patients with varicose veins undergo a thorough assessment in a Vascular Surgical outpatient clinic. Patients who have clinical evidence of varicose veins and meet the initial inclusion/exclusion criteria will then be made aware of this research study and provided with the appropriate information, including a Patient Information Sheet | |||||||||
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Pre-assignment
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Screening details |
Interested patients will attend a screening appointment with one of the study investigators in the Vascular Laboratory at Hull Royal Infirmary. At this appointment, the medical history and examination from the outpatient visit will be reviewed. If they have not done so already, patients will undergo a duplex venous ultrasound. | |||||||||
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Period 1
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Period 1 title |
Baseline (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
Prior to intervention, patients will be randomised to receive either buffered or unbuffered tumescent, using computer-generated random permuted block randomisation in a 1:1 ratio. This is a single-blinded trial; patients will be blinded to randomisation.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Buffered | |||||||||
Arm description |
Addition of 10 ml of 8.4% sodium bicarbonate to 1 l of standard tumescent anaesthetic solution. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Sodium Bicarbonate Injection BP 8.4% w/v
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
By slow intravenous injection or infusion. An amount appropriate to the body - base deficiency up to 300mmol. Plasma pH should be measured at regular intervals.
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Arm title
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Non Buffered | |||||||||
Arm description |
Received EVTA with standard non-buffered TLA (the control group) | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Buffered
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Reporting group description |
Addition of 10 ml of 8.4% sodium bicarbonate to 1 l of standard tumescent anaesthetic solution. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Non Buffered
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Reporting group description |
Received EVTA with standard non-buffered TLA (the control group) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Buffered
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Reporting group description |
Addition of 10 ml of 8.4% sodium bicarbonate to 1 l of standard tumescent anaesthetic solution. | ||
Reporting group title |
Non Buffered
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Reporting group description |
Received EVTA with standard non-buffered TLA (the control group) | ||
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End point title |
Less perioprocedural pain | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Patients followed-up at 1, 6, and 12 weeks post EVLA
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Statistical analysis title |
Statistical Analysis Plan | ||||||||||||
Statistical analysis description |
All continuous variables will be checked for normality using histograms and normality tests. Intergroup and intragroup comparisons will be performed using parametric tests for normally distributed variables. Log transformation will be performed for skewed variables to convert to a normal distribution for parametric testing. Non-parametric tests will be used if distribution remains skewed despite log transformation. Categorical variables will be compared using Chi-square and Fischer’s exact test
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Comparison groups |
Buffered v Non Buffered
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
< 0.05 [1] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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| Notes [1] - A p-value<0.05 was taken to indicate statistical significance. Univariate regression analyses were performed to assess for any confounding effect of the baseline parameters. |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events reported in accordance with Hull and East Yorkshire Hospitals NHS Trust R&D (HEY R&D) Safety Reporting standard operating procedures. Investigators will notify HEY R&D of serious adverse events within 24hrs.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| 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: Full published results attached. |
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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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10 Jan 2014 |
Inclusion criteria amended to increase the applicability of results to all aspects of varicose vein endovenous treatment. Exclusion criteria to increase the applicability of results to all aspects of vv endovenous treatment. Additional statistical analysis paragraph to allow interim analysis.
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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/27306991 |
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