Clinical Trial Results:
Epidural ropivacaine as part of a multimodal postoperative pain treatment following thoracolumbar spinal fusion surgery.
Summary
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EudraCT number |
2014-004713-91 |
Trial protocol |
BE |
Global end of trial date |
06 Aug 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
03 May 2025
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First version publication date |
03 May 2025
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Other versions |
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Summary report(s) |
Article_Tose |
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 |
ROPISPINE
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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 |
UZ Brussel
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Sponsor organisation address |
Laarbeeklaan, Brussel, Belgium,
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Public contact |
Study Coordinator, UZ Brussel, virgini.vanbuggenhout@uzbrussel.be
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Scientific contact |
Study Coordinator, UZ Brussel, virgini.vanbuggenhout@uzbrussel.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 |
23 Oct 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Oct 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Aug 2024
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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 goal of this study is to determine if infusion with ropivacaine at a rate of 7 mL/h is an effective additional treatment for postoperative pain after thoracolumbar spinal fusion surgery.
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Protection of trial subjects |
Patient safety was assessed during study condut. Diring srgery patient was followed by PI, anesthesiologist and surgery team. Afterwards they were followed up by medical staff. At the pacu they had to give pain scores every 10 minutes, in that pain and AE's could be assessed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Dec 2014
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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: 33
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Worldwide total number of subjects |
33
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EEA total number of subjects |
33
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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) |
33
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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 |
Patients who were scheduled for thoracic or lumbar posterior interbody fusion surgery between december 2014 and December 2015 were included. | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
33 | |||||||||
Number of subjects completed |
30 | |||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
not the right premedication was given: 2 | |||||||||
Reason: Number of subjects |
problem during surgery, no epidural possible: 1 | |||||||||
Period 1
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Period 1 title |
study conduct (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind [1] | |||||||||
Roles blinded |
Subject, Data analyst, Carer, Assessor | |||||||||
Blinding implementation details |
Only PI is not blinded and prepares the medication to be given to the patient, everybody else in the theatre room is blinded. Block randomization was used. All patients scheduled for surgery on a certain day were randomized to the same group.
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Arms
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Are arms mutually exclusive |
Yes
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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 |
Saline
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Epidural use
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Dosage and administration details |
continuous infusion of 0.9% saline
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Arm title
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treatment group | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
ropivacaine
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Investigational medicinal product code |
ropivacaine
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Epidural use
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Dosage and administration details |
continuous infusion of 0.2% ropivacaine during surgery
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Notes [1] - The roles blinded appear to be inconsistent with a double blind trial. Justification: Only the PI was not blinded in this study. Everybody else was blinded (patient, anesthesiologist, surgeon,...) |
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Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 17 patients were included in the placebo group at first, however not the right premedication was given before surgery and for one patient placement of an epidural wasn't possible. Those 3 were excluded from the study. No data was used from them. |
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Baseline characteristics reporting groups
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Reporting group title |
placebo group
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Reporting group description |
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Reporting group title |
treatment group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
placebo group
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Reporting group description |
- | ||
Reporting group title |
treatment group
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Reporting group description |
- |
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End point title |
VAS Score | |||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
VAS Score were taken at arrival at PACU and then every 10 minutes while still on PACU. VAS score was also measured on day of surgery (day 0), day 1 and day 2.
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Statistical analysis title |
VAS Score | |||||||||||||||||||||||||||
Statistical analysis description |
We aimed to detect a 40% reduction in VAS score in the treatment group as compared with the control group. We set type I error α = 0.05 (two-sided) and type II error b = 0.2. For statistical analysis SPSS Statistics® version 23 was used. The normality of the distribution was assessed using Kolmogorov-Smirnov test. The student T-test was used for analysing the differences between the two groups.
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Comparison groups |
placebo group v treatment group
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||
P-value |
< 0.05 | |||||||||||||||||||||||||||
Method |
t-test, 1-sided | |||||||||||||||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||||||||||||||
Confidence interval |
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level |
95% | |||||||||||||||||||||||||||
sides |
1-sided
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lower limit |
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upper limit |
- |
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End point title |
Supplemental opioid consumption | |||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
supplemental opioid consumption was captured in the OR (mg sufentanyl) at the PACU (mg piritramide) and on day 0, day 1 and day 2 (mg oxycodone).
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Statistical analysis title |
opioid consumption | |||||||||||||||||||||||||||
Statistical analysis description |
Assuming a standard deviation of 2, a minimum of 16 patients per group would be required.
We set type I error α = 0.05 (two-sided) and type II error b = 0.2. For statistical analysis SPSS Statistics® version 23 was used. The normality of the distribution
was assessed using the Kolmogorov-Smirnov test. The student T-test was used for analysing the differences between the two groups.
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Comparison groups |
treatment group v placebo group
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||
P-value |
< 0.05 | |||||||||||||||||||||||||||
Method |
t-test, 1-sided | |||||||||||||||||||||||||||
Confidence interval |
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End point title |
day of mobilization | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
day of mobilization is the day patients started walking again after surgery.
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No statistical analyses for this end point |
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End point title |
Hospitalization | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
length of stay of hospitalization
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were captured as from time of signing the ICF till end of the hospitalization.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20
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Reporting groups
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Reporting group title |
placebo group
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Reporting group description |
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Reporting group title |
treatment 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 |