Clinical Trial Results:
Postoperative analgesia after elective hip surgery - effect of obturator nerve blockade
Summary
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EudraCT number |
2017-000068-14 |
Trial protocol |
DK |
Global end of trial date |
08 Jun 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Nov 2019
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First version publication date |
27 Nov 2019
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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 |
HIP/FUSION#2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03064165 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Thomas Fichtner Bendtsen
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 165, Aarhus N, Denmark,
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Public contact |
Niels Dalsgaard Nielsen, Elective Surgery Center, +45 22838334, nielsdn@dadlnet.dk
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Scientific contact |
Niels Dalsgaard Nielsen, Elective Surgery Center, +45 22838334, nielsdn@dadlnet.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 |
14 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 Jun 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Jun 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 |
To estimate the effect of obturator nerve blockade on postoperative opioid consumption 0-12 hours after total hip replacement.
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Protection of trial subjects |
No specific measures was observed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2017
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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: 62
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Worldwide total number of subjects |
62
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EEA total number of subjects |
62
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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) |
17
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From 65 to 84 years |
41
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85 years and over |
4
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Recruitment
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Recruitment details |
We included patients aged ≥18 years with ASA I–III status who were scheduled for primary THA in spinal anesthesia at the Elective Surgery Center, Silkeborg Regional Hospital, Silkeborg, Denmark. | |||||||||||||||
Pre-assignment
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Screening details |
Assessed for eligibility, n=284; Excluded, n=222, cause of exclusion: Meeting exclusion criteria, n=154, Declined to participate, n=33, Other reasons, n=35; Randomized, n=62, thereof: Completing trial, n=60, Excluded after inclusion, n=2. | |||||||||||||||
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 nerve block | |||||||||||||||
Arm description |
Subjects received an active obturator nerve block within 1 hour after total hip arthroplasty. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Bupivacaine 5 mg/mL with epinephrine 5 μg/mL
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Perineural use
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Dosage and administration details |
Single injection of 15 mL bupivacaine 5 mg/mL with epinephrine 5 μg/mL in the interfacial plane between the pectineus and external obturator muscles.
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Arm title
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Sham nerve block | |||||||||||||||
Arm description |
Subjects received a sham obturator nerve block (placebo) within 1 hour after total hip arthroplasty. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Perineural use
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Dosage and administration details |
Single injection of 15 mL bupivacaine 5 mg/mL with epinephrine 5 μg/mL in the interfacial plane between the pectineus and external obturator muscles.
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End points reporting groups
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Reporting group title |
Active nerve block
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Reporting group description |
Subjects received an active obturator nerve block within 1 hour after total hip arthroplasty. | ||
Reporting group title |
Sham nerve block
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Reporting group description |
Subjects received a sham obturator nerve block (placebo) within 1 hour after total hip arthroplasty. |
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End point title |
Cumulated opioid dose (0-12 h) | ||||||||||||
End point description |
Opioid consumption was converted to Oram morphine equivalents
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End point type |
Primary
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End point timeframe |
0-12 hours after surgery
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Statistical analysis title |
Student t-test | ||||||||||||
Comparison groups |
Sham nerve block v Active nerve block
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.93 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.6
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-14 | ||||||||||||
upper limit |
13 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
6.9
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End point title |
Cumulated opioid dose (12-18 h) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12–18 hours after surgery
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No statistical analyses for this end point |
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End point title |
Pain score at rest (1 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
1 hour after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Pain score at rest (2 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
2 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Pain score at rest (5 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
5 hours after end-of-surgery.
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No statistical analyses for this end point |
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End point title |
Pain score at rest (7 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
7 hours after end-of-surgery.
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No statistical analyses for this end point |
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End point title |
Pain score at rest (24 h) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
24 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Pain score during passive 90° flexion of the hip (1 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
1 hour after end-of-surgery.
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No statistical analyses for this end point |
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End point title |
Pain score during passive 90° flexion of the hip (2 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
2 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Pain score during passive 90° flexion of the hip (5 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
5 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Pain score during passive 90° flexion of the hip (7 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
5 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Pain score during passive 90° flexion of the hip (24 h) | ||||||||||||
End point description |
Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
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End point type |
Secondary
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End point timeframe |
24 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Intensity of nausea (1 h) | ||||||||||||
End point description |
Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
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End point type |
Secondary
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End point timeframe |
1 hour after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Intensity of nausea (2 h) | ||||||||||||
End point description |
Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
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End point type |
Secondary
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End point timeframe |
2 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Intensity of nausea (5 h) | ||||||||||||
End point description |
Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
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End point type |
Secondary
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End point timeframe |
5 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Intensity of nausea (7 h) | ||||||||||||
End point description |
Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
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End point type |
Secondary
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End point timeframe |
7 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Intensity of nausea (24 h) | ||||||||||||
End point description |
Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
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End point type |
Secondary
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End point timeframe |
24 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Number of episodes of emesis (0-18 h) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0 to 18 hours after end-of surgery
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No statistical analyses for this end point |
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End point title |
Cumulated dose of ondansetron (0-18 h) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0 to 18 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Cumulated dose of droperidol (0-18 h) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
0 to 18 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Time to discharge from the postanesthesia care unit (PACU) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From end-of-surgery until discharge from PACU.
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No statistical analyses for this end point |
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End point title |
Time to discharge from the hospital | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time from end-of-surgery to discharge from hospital.
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No statistical analyses for this end point |
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End point title |
Duration of the spinal anesthesia | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time from end-of-surgery until subject regains normal sensibility on anterior surface of femur.
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No statistical analyses for this end point |
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End point title |
Quality of sleep | ||||||||||||||||||
End point description |
Quality of sleep during the first night after surgery
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End point type |
Secondary
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End point timeframe |
24 hours
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No statistical analyses for this end point |
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End point title |
Ability to ambulate (5 h) | ||||||||||||
End point description |
The ability to ambulate was assessed by physiotherapists using a standardized ambulation test ranging from 0 (subject was unable to ambulate to sitting position) to 8 (subject could walk with elbow crutches without personal physical support).
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End point type |
Secondary
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End point timeframe |
5 hours after end-of-surgery
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No statistical analyses for this end point |
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End point title |
Muscular control of the operated leg during ambulation (5 h) | ||||||||||||
End point description |
The range of the muscular control score was 0 (subject was unable to ambulate to sitting position) to 3 (subject had good muscular control of the operated leg during all activities)
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End point type |
Secondary
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End point timeframe |
5 hours after end-of-surgery.
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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 |
24 hours after end-of-surgery
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
Active nerve block
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Reporting group description |
Subjects received an active obturator nerve block within 1 hour after total hip arthroplasty. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sham nerve block
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Reporting group description |
Subjects received a sham obturator nerve block (placebo) within 1 hour after total hip arthroplasty. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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/31650529 |