Clinical Trial Results:
Suprascapular nerve block as postoperative analgesia after artroscopic shoulder surgery - a randomized, blinded, placebo controlled trial.
Summary
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EudraCT number |
2015-002391-24 |
Trial protocol |
DK |
Global end of trial date |
27 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Dec 2020
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First version publication date |
26 Dec 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 |
SSNBCSH01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Nordsjællands Hospital
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Sponsor organisation address |
Dyrehavevej 29, Hillerød, Denmark, 3400
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Public contact |
Kai Henrik Wiborg Lange, Nordsjaellands Hospital, kai.henrik.wiborg.lange@regionh.dk
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Scientific contact |
Department of Anaesthesiology, Nordsjaellands Hospital, kai.henrik.wiborg.lange@regionh.dk
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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 Aug 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Aug 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Aug 2018
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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 objective of this study is to examine the reduction in postoperative pain after arthroscopic shoulder surgery in patients treated with a suprascapular nerve block.
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Protection of trial subjects |
Standard postoperative care at the Postoperative Care Unit.
Treatment of pain:
Active Group: Nerve block and PCA-pump with morphine
Placebo Group: PCA-pump with morphine
PCA = Patient-controlled analgesia.
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
01 Aug 2015
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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 |
Denmark: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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) |
34
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
40 | |||||||||
Number of subjects completed |
40 | |||||||||
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, Monitor, Data analyst, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Active group | |||||||||
Arm description |
Suprascapular nerve block with active drug (Ropivacaine 7.5 mg*ml-1) | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ropivacaine
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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 |
Perineural use
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Dosage and administration details |
Administered perineurally in relation to the suprascapular nerve as a single shot bolus of 5 ml Ropivacaine 7.5 mg*ml-1
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Arm title
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Placebo group | |||||||||
Arm description |
Suprascapular nerve block with placebo (Saline 9 mg*ml-1) | |||||||||
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
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Routes of administration |
Perineural use
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Dosage and administration details |
Administered perineurally in relation to the suprascapular nerve as a single shot bolus of 5 ml Saline 9 mg*ml-1
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Baseline characteristics reporting groups
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Reporting group title |
Active group
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Reporting group description |
Suprascapular nerve block with active drug (Ropivacaine 7.5 mg*ml-1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo group
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Reporting group description |
Suprascapular nerve block with placebo (Saline 9 mg*ml-1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Active group
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Reporting group description |
Suprascapular nerve block with active drug (Ropivacaine 7.5 mg*ml-1) | ||
Reporting group title |
Placebo group
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Reporting group description |
Suprascapular nerve block with placebo (Saline 9 mg*ml-1) |
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End point title |
VAS reduction at T30 | ||||||||||||
End point description |
Change in pain score (VAS 0-100mm) from baseline to T30 (30 minutes after application of nerve block)
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End point type |
Primary
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End point timeframe |
From Baseline to T30
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Statistical analysis title |
VAS score reduction from baseline to T30 | ||||||||||||
Comparison groups |
Active group v Placebo group
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
VAS AUC T30-T360 during maximum abduction | ||||||||||||
End point description |
VAS score at maximum active abduction of the shoulder ½-6 hours after injection measured as area under the curve (T30-T360; AUC)
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End point type |
Secondary
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End point timeframe |
From T30-T360
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Statistical analysis title |
AUC T30-T360 abduction | ||||||||||||
Comparison groups |
Active group v Placebo group
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.013 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
AUC T30-T360 at rest | ||||||||||||
End point description |
VAS score at maximum active abduction of the shoulder ½-6 hours after injection measured as area under the curve (T30-T360; AUC)
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End point type |
Secondary
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End point timeframe |
T30-T360
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Statistical analysis title |
AUC T30-T360 rest | ||||||||||||
Comparison groups |
Active group v Placebo group
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.01 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Total morphine usage T0-T360 | ||||||||||||
End point description |
Total use of morphine from 0-6 hours after injection (T0-T360)
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End point type |
Secondary
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End point timeframe |
T0-T360
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Statistical analysis title |
Morphine T0-T360 | ||||||||||||
Comparison groups |
Active group v Placebo group
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.01 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Change in infraspinatus sEMG from baseline to T30 | ||||||||||||
End point description |
Change in activity of the infraspinatus muscle during maximum voluntary isometric contraction from baseline to T30 measured with surface EMG (sEMG)
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End point type |
Secondary
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End point timeframe |
From baseline to 30 minutes after injection (T30)
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Notes [1] - sEMG signals too poor to analyze [2] - sEMG signals too poor to analyze |
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No statistical analyses for this end point |
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End point title |
Change in external rotation shoulder strength from baseline to T30 | ||||||||||||
End point description |
Percentage change in maximum voluntary isometric contraction during external rotation of the shoulder from baseline to 30 minutes after injection (T30) measured with a handheld dynamometer.
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End point type |
Secondary
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End point timeframe |
From baseline measurements to 30 minuters after injection (T30)
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Statistical analysis title |
Change in external rotation strength T0-T30 | ||||||||||||
Comparison groups |
Active group v Placebo group
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Change in abduction shoulder strength from baseline to T30 | ||||||||||||
End point description |
Percentage change in maximum voluntary isometric contraction during abduction of the shoulder from baseline to 30 minutes after injection (T30) measured with a handheld dynamometer.
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End point type |
Secondary
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End point timeframe |
From baseline to T30
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Statistical analysis title |
Change in abduction strength T0-T30 | ||||||||||||
Comparison groups |
Active group v Placebo group
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
24th november 2015 - 27th august 2018
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
SNOMED CT | |||||||||||||||
Dictionary version |
DK 2015
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Reporting groups
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Reporting group title |
Ropivacaine 7.5 mg*ml-1
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Reporting group description |
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Reporting group title |
Saline 9 mg*ml-1
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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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: No non-serious adverse events recorded during the study period. |
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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. | |||
Unable to analyze surface electromyography (sEMG) data due to very poor sEMG signals. |