Clinical Trial Results:
Continous wound infiltration after hallux valgus surgery
Summary
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EudraCT number |
2013-005106-64 |
Trial protocol |
AT |
Global end of trial date |
30 Apr 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Jul 2020
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First version publication date |
17 Jul 2020
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Other versions |
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Summary report(s) |
DSUR CWI-HVS |
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 |
CWI-HVS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02182999 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University Innsbruck
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Sponsor organisation address |
Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
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Public contact |
Univ.Prof. Dr. Martin Krismer
, Medical University Innsbruck
University Hospital for Orthopaedics
Anichstrasse 35
6020 Innsbruck, 43 512/504-22691, martin.krismer@tirol-kliniken.at
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Scientific contact |
Univ.Prof. Dr. Martin Krismer
, Medical University Innsbruck
University Hospital for Orthopaedics
Anichstrasse 35
6020 Innsbruck, 43 512/504-22691, martin.krismer@tirol-kliniken.at
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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 |
30 Apr 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Apr 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Apr 2017
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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 aim of this study was to investigate the effect of continous wound infiltration with long-lasting local anesthetics in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control.
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Protection of trial subjects |
Patients received 1.3 mg hydromorphone (Hydal, Mundipharma GmbH, Vienna, Austria) as a rescue medication for NRS (numeric rating scale; 1-10, higher numbers indicating increasing pain level) pain score greater than 3.
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Background therapy |
For postoperative pain management, naproxen 500 mg (Naprobene; ratiopharm Arzneimittel Vertriebs-GmbH, Vienna, Austria) was administered twice a day. Patients were routinely discharged the second day after surgery and 500 mg of naproxen twice a day was prescribed for 5 days. | ||
Evidence for comparator |
Hallux valgus surgery is usually associated with significant postoperative pain, especially during the first 24 hours postoperatively. Previous studies showed that the CWI (continuous wound infiltration / infusion) of local anesthetics provides sufficient postoperative analgesia and reduces postoperative narcotic consumption without an increased risk of complications. | ||
Actual start date of recruitment |
03 Mar 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Austria: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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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) |
35
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients undergoing a distal metatarsal osteotomy and lateral release with or without concomitant osteotomy of the proximal phalanx of the greater toe (Akin osteotomy) for idiopathic hallux valgus deformity at the Department of Orthopedic Surgery, Medical University of Innsbruck, between May 2014 and March 2017 were screened for eligibility. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 294 osteotomies of the first metatarsal were performed for idiopathic hallux valgus deformity at the Department of Orthopedic Surgery, Medical University of Innsbruck, between May 2014 and March 2017. After screening for eligibility, 50 patients were enrolled in the study. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Recruitment
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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 | ||||||||||||||||||||||||
Blinding implementation details |
A randomization sequence was generated by computer software (http://www.randomizer.org). A randomization list from 1 to 50 was created, each number encoding for treatment or placebo group. The numbers were placed in 50 individual sealed opaque envelopes marked 1 to 50. The randomization list was stored in a locked room and could only be accessed by one independent member of the nursing staff, who prepared the study medication but did not take part in patient care.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment goup | ||||||||||||||||||||||||
Arm description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany). | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Ropinaest®
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infiltration
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Dosage and administration details |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine
2 mg/mL (Gebro GmbH, 6391 Fieberbrunn, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).
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Arm title
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Placebo group | ||||||||||||||||||||||||
Arm description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany). | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Physiologic salt solution
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Investigational medicinal product code |
PL1
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infiltration
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Dosage and administration details |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with Physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).
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Period 2
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Period 2 title |
Follow-up period
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Is this the baseline period? |
No | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||
Blinding implementation details |
A randomization sequence was generated by computer software (http://www.randomizer.org). A randomization list from 1 to 50 was created, each number encoding for treatment or placebo group. The numbers were placed in 50 individual sealed opaque envelopes marked 1 to 50. The randomization list was stored in a locked room and could only be accessed by one independent member of the nursing staff, who prepared the study medication but did not take part in patient care.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment goup | ||||||||||||||||||||||||
Arm description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany). | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Ropinaest®
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infiltration
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Dosage and administration details |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine
2 mg/mL (Gebro GmbH, 6391 Fieberbrunn, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).
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Arm title
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Placebo group | ||||||||||||||||||||||||
Arm description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany). | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Physiologic salt solution
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Investigational medicinal product code |
PL1
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infiltration
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Dosage and administration details |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with Physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).
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Baseline characteristics reporting groups
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Reporting group title |
Treatment goup
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo group
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment goup
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany). | ||
Reporting group title |
Placebo group
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany). | ||
Reporting group title |
Treatment goup
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany). | ||
Reporting group title |
Placebo group
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany). |
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End point title |
Average pain level during the first 48 hours after surgery | |||||||||||||||
End point description |
The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were recorded by members of the nursing staff every 4 hours after the procedure until discharge, with the exception of the control at 4 am in the morning (16 hours, 40 hours), when most patients were asleep.
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End point type |
Primary
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End point timeframe |
Day 1- day 3
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Statistical analysis title |
Pain level | |||||||||||||||
Comparison groups |
Placebo group v Treatment goup
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.596 | |||||||||||||||
Method |
t-test, 2-sided | |||||||||||||||
Confidence interval |
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End point title |
Peak pain level during the first 48 hours after surgery | |||||||||||||||
End point description |
The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were recorded by members of the nursing staff every 4 hours after the procedure until discharge, with the exception of the control at 4 am in the morning (16 hours, 40 hours), when most patients were asleep.
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End point type |
Primary
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End point timeframe |
Day 1- day 3
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Statistical analysis title |
Peak pain level | |||||||||||||||
Comparison groups |
Treatment goup v Placebo group
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.353 | |||||||||||||||
Method |
t-test, 2-sided | |||||||||||||||
Confidence interval |
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End point title |
Rescue medicaton during the first 48 hours after surgery | |||||||||||||||
End point description |
Patients received 1.3 mg hydromorphone (Hydal, Mundipharma GmbH, Vienna, Austria) as a rescue medication for NRS pain score greater than 3. Mean narcotic consumption during the first 48 hours after surgery did not differ significantly between both groups, although there was a trend toward a lower need for rescue medication in the treatment group compared with the control group.
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End point type |
Secondary
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End point timeframe |
Day 1-day 3
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Statistical analysis title |
Rescue medication | |||||||||||||||
Comparison groups |
Treatment goup v Placebo group
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.354 | |||||||||||||||
Method |
t-test, 2-sided | |||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
03.03.2014-30.04.2017
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
Treatment goup
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany). | ||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo group
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Reporting group description |
Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany). | ||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||
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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/29073780 |