Clinical Trial Results:
Effectiveness of Added blocking of radial and median nerves with levobupivacaine in the control of postoperative pain in the rhizarthrosis ambulatory surgery
Summary
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EudraCT number |
2011-001340-29 |
Trial protocol |
ES |
Global end of trial date |
03 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Jul 2021
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First version publication date |
23 Jul 2021
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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 |
IIBSP-LEV-2011-21
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01597479 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
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Sponsor organisation address |
Sant Quintí 77-79, Barcelona, Spain, 08041
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Public contact |
UICEC Sant Pau, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, 34 935537636, uicec@santpau.cat
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Scientific contact |
UICEC Sant Pau, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau, 34 935537636, uicec@santpau.cat
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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 |
21 Mar 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Apr 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Feb 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 |
To study the efficacy of peripheral block of the radial and median nerves to control pain after outpatient surgery for rhizarthrosis at the time of maximum intensity, that is, in the first 24-48 hours.
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Protection of trial subjects |
This trial was conducted in compliance with the principles laid down the Declaration of Helsinki and all applicable EU and national laws.
In addition, it adheres to the principles expressed in ICH-GCP (International Conference on Harmonization - Good Clinical Practice) and the requirements of the EU and National Data Protection Regulation.
Study protocol including consent documents were approved in advance by the leading Ethic Committee, by competent authorities and any other regulatory bodies (as specified by national regulations).
Participants in the clinical trial were adequately informed prior to their inclusion. In particular, all patients were informed about the voluntary nature of his/her participation, confidentiality and protection of his/her data, potential risks and benefits of participation, insurance coverage and the possibility of withdrawal at any time. The principle of patient autonomy was clearly enforced. Freely given informed consent was obtained from and documented in writing, signed and dated personally by each patient (or by an individual or juridical or other body authorized under applicable law to consent on behalf of a prospective subject) before he/she is inclusion in any study or project.
The protection of human subjects is also promoted by adequate monitoring of drug/treatment safety.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2010
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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 |
Spain: 52
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Worldwide total number of subjects |
52
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EEA total number of subjects |
52
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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) |
0
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From 65 to 84 years |
52
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85 years and over |
0
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Recruitment
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Recruitment details |
We enrolled consecutive adult ASA I-III patients undergoing elective ambulatory trapeziectomy from February 2012 to april 2014. | |||||||||
Pre-assignment
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Screening details |
-Men or women over 18 years of age. -Outpatient surgery for rhizarthrosis. -Free acceptance to participate in the study, with consent informed signed by the patient, guardian or responsible family member. | |||||||||
Pre-assignment period milestones
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Number of subjects started |
52 | |||||||||
Number of subjects completed |
52 | |||||||||
Period 1
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Period 1 title |
Visit 1
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ARM H | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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ARM R | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Levobupivacaína
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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 |
Injection
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Dosage and administration details |
Infiltration and nerve block with 5 mL 0.125% levobupivacaine
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Period 2
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Period 2 title |
Visit 2
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ARM H | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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ARM R | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Levobupivacaína
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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 |
Injection
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Dosage and administration details |
Infiltration and nerve block with 5 mL 0.125% levobupivacaine
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Baseline characteristics reporting groups
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Reporting group title |
ARM H
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ARM R
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ARM H
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Reporting group description |
- | ||
Reporting group title |
ARM R
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Reporting group description |
- | ||
Reporting group title |
ARM H
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Reporting group description |
- | ||
Reporting group title |
ARM R
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Reporting group description |
- |
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End point title |
Pain intensity at 24 and 48 hours after trapeziectomy | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 and 48 post trapeziectomy
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Statistical analysis title |
x2 | ||||||||||||||||||||
Comparison groups |
ARM H v ARM R v ARM H v ARM R
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Number of subjects included in analysis |
104
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Analysis specification |
Post-hoc
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Analysis type |
equivalence | ||||||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||||||
Method |
Chi-squared | ||||||||||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
1-sided
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lower limit |
0 | ||||||||||||||||||||
upper limit |
10 | ||||||||||||||||||||
Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
48 hours
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Assessment type |
Systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
ARM H
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Reporting group description |
Received an axillary brachial plexus block before surgery | |||||||||||||||||||||
Reporting group title |
ARM R
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Reporting group description |
Patients received an axillary brachial plexus block before surgery. In the postanesthesia care unit , patients in this group received a concomitant block of the median and radial nerves at the elbow | |||||||||||||||||||||
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29405670 |