Clinical Trial Results:
The Efficacy of Continuous Intra-articular Infusion of Local Anaesthetic Agent following Elective Primary Hip Arthroplasty
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Summary
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EudraCT number |
2011-001510-33 |
Trial protocol |
GB |
Global end of trial date |
26 Aug 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Dec 2020
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First version publication date |
17 Dec 2020
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Other versions |
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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 |
RR11/9781
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Additional study identifiers
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ISRCTN number |
ISRCTN24271997 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Leeds Teaching Hospitals NHS Trust
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Sponsor organisation address |
Beckett Street , Leeds, United Kingdom, LS9 7TF
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Public contact |
Dr Martin Stone , Leeds Teaching Hospitals NHS Trust , martin.stone@nhs.net
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Scientific contact |
Dr Martin Stone , Leeds Teaching Hospitals NHS Trust , martin.stone@nhs.net
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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 |
26 Aug 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Aug 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Aug 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To determine whether the use of a continuous intra-articular infusion of local anaesthetic might reduce the need for post-operative opiate use in patients undergoing hip replacement.
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Protection of trial subjects |
This clinical trial, which involves the use of an investigational medicinal product has been designed and will be run in accordance with the Principles of GCP and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004 / 1031) and any subsequent amendments of the clinical trial regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2012
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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 |
United Kingdom: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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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 attending for unilateral, elective primary hip arthroplasty will be randomised into one of two groups, Treatment, and Control. :A verbal explanation of the trial and Patient Information Leaflet (PIL) will be provided by the authorised trial clinician for the patient to consider. | |||||||||
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Pre-assignment
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Screening details |
It is essential that patients greater than 70 years old are recruited to the study. Many patients presenting for primary hip arthroplasty are in this age group and it is anticipated that reduced post operative morphine consumption in these patients will be of particular benefit. | |||||||||
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Period 1
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Period 1 title |
Main Trial Period (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, Assessor | |||||||||
Blinding implementation details |
The ODP will complete a tick-box form on carbon paper which records the contents of the pain pump and the medicinal product batch numbers. The top copy will bear a patient information sticker and the other copy will have only the study reference number and no patient identifiable information. The top copy of the form is placed in a sealed, opaque envelope which is stapled to the inside of the patient’s notes. The other copy is placed in a sealed, opaque envelope and put into a secure storage
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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 | |||||||||
Arm description |
Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of bupivacaine local anaesthetic over the following 48 hours. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
bupivacaine local anaesthetic
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Bupivacaine hydrochloride is presented as a clear, colourless solution for injection in a range of concentrations. The 2.5mg/ml concentration is used in the LIA study. Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of bupivacaine local anaesthetic over the following 48 h.
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Arm title
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Placebo | |||||||||
Arm description |
Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of saline placebo over the following 48 h. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of saline placebo over the following 48 h.
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Baseline characteristics reporting groups
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Reporting group title |
Main Trial Period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of bupivacaine local anaesthetic over the following 48 hours. | ||
Reporting group title |
Placebo
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Reporting group description |
Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of saline placebo over the following 48 h. | ||
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End point title |
30% reduction in the amount of opiate analgesia required by patients 48 hour post-operative period [1] | |||||||||
End point description |
A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.
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End point type |
Primary
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End point timeframe |
The primary endpoint is a 30% reduction in the amount of opiate analgesia required by patients in the 48 hour post-operative period in the treatment group compared to the placebo group.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required. |
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| Notes [2] - data analysis is incomplete for this trial. [3] - data analysis is incomplete for this trial. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
AEs will be collected for all patients and will be evaluated for duration and intensity according to the NCRI Common Toxicity Criteria.
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Adverse event reporting additional description |
AEs will be collected for all patients from first dose of protocol treatment until 30 days after the last dose of treatment with a protocol IMP.
Information about AEs, whether volunteered by the patient, discovered by the investigator questioning or detected through physical examination, laboratory test or other investigation will be collected
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4.0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| 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: A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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26 Aug 2015 |
The trial had multiple substantial amendments, but a full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required. |
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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. | |||
| A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication | |||
