Clinical Trial Results:
A study to Investigate the Effect of Intraperitoneal Levobupivacaine on Post Operative Laparoscopic Pain
Summary
|
|
EudraCT number |
2009-011207-23 |
Trial protocol |
GB |
Global end of trial date |
27 Jul 2015
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
11 Aug 2019
|
First version publication date |
11 Aug 2019
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
R0831
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Hull and East Yorkshire Hospitals NHS Trust
|
||
Sponsor organisation address |
Anlaby Road , Hull, United Kingdom, HU3 2JZ
|
||
Public contact |
Research & Development Department
, Hull and East Yorkshire Hospitals NHS Trust, 044 01482461903, research.development@hey.nhs.uk
|
||
Scientific contact |
Women and Children's Hospital
, Hull and East Yorkshire Hospitals NHS Trust, 044 01482461271, research.development@hey.nhs.uk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
19 May 2015
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
27 Jul 2015
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The principle research question is whether leaving a local anaesthetic solution in the abdomen after keyhole surgery improves pain relief.
|
||
Protection of trial subjects |
Nothing specific to this trial, all participants received general anaesthesia as per normal surgical practice.
|
||
Background therapy |
General anaesthetic as per Trust standard induction process. | ||
Evidence for comparator |
The comparator in this study was sodium chloride. This was the choice of comparator due to the minimal risk of any adverse reactions or complications. | ||
Actual start date of recruitment |
09 Jun 2011
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 109
|
||
Worldwide total number of subjects |
109
|
||
EEA total number of subjects |
109
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
103
|
||
From 65 to 84 years |
6
|
||
85 years and over |
0
|
|
|||||||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||||||
Recruitment details |
All patients were recruited between 09.06.11 and 27.07.15. All patients were recruited from surgical/gynaecological clinics within the Hull and East Yorkshire Hospitals NHS Trust. | ||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||
Screening details |
Patients attended for minor laparoscopic gynaecological procedure. They had a BMI of less than 35 who weighed more than 50kg with an ASA less than or equal to 2. Any patient no fulfilling these criteria were excluded from the study. | ||||||||||||||||||||||||
Period 1
|
|||||||||||||||||||||||||
Period 1 title |
Overall study (overall period)
|
||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Data analyst, Carer | ||||||||||||||||||||||||
Blinding implementation details |
IMP and comparator dispensed in identical packaging from pharmacy directly to the anaesthetist who administered this.
|
||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||
Arm title
|
Levobupvicaine | ||||||||||||||||||||||||
Arm description |
Patients received 40mls of 0.25% levobupivacaine instilled into the peritoneal cavity at the end of the procedure and left in situ. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Levobupivicaine
|
||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for injection
|
||||||||||||||||||||||||
Routes of administration |
Intraperitoneal use
|
||||||||||||||||||||||||
Dosage and administration details |
Levobupivicaine 0.25% 40mls
|
||||||||||||||||||||||||
Investigational medicinal product name |
Sodium Chloride
|
||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection
|
||||||||||||||||||||||||
Routes of administration |
Intraperitoneal use
|
||||||||||||||||||||||||
Dosage and administration details |
Sodium Chloride 0.9% 40mls
|
||||||||||||||||||||||||
Arm title
|
Comparator | ||||||||||||||||||||||||
Arm description |
0.9% normal saline | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Saline 0.9%
|
||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||
Pharmaceutical forms |
Solution for infusion
|
||||||||||||||||||||||||
Routes of administration |
Intraperitoneal use
|
||||||||||||||||||||||||
Dosage and administration details |
40 mls administered viaintraperitoneal route
|
||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall study
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Levobupvicaine
|
||
Reporting group description |
Patients received 40mls of 0.25% levobupivacaine instilled into the peritoneal cavity at the end of the procedure and left in situ. | ||
Reporting group title |
Comparator
|
||
Reporting group description |
0.9% normal saline |
|
|||||||||||||
End point title |
Pain | ||||||||||||
End point description |
Each subject was asked to record a score for pain at the wound sites, pelvis and shoulder tip at each of the time points. A record was kept of anaesthesia administered and of analgesia administered postoperatively whilst still in hospital and analgesia taken after discharge until the completion of their four-day numerical scale completion.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Assessment of post-operative pain at 3 hours, 8 hours, 24 hours and 96 hours.
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Should tip pain 3 hours post surgery | ||||||||||||
Statistical analysis description |
A correlation will be sought between the two groups
- pain scores (at the various sites and time points)
|
||||||||||||
Comparison groups |
Levobupvicaine v Comparator
|
||||||||||||
Number of subjects included in analysis |
102
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.036 [1] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Notes [1] - Shoulder tip pain 3 hour post surgery |
|||||||||||||
Statistical analysis title |
Wound pain 8 hour post surgery | ||||||||||||
Comparison groups |
Comparator v Levobupvicaine
|
||||||||||||
Number of subjects included in analysis |
102
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.045 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|||||||||||||
Statistical analysis title |
Wound pain 4 day post surgery | ||||||||||||
Comparison groups |
Levobupvicaine v Comparator
|
||||||||||||
Number of subjects included in analysis |
102
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.042 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From time of consent to 30 days post intervention.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Pain scores and diary completion.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Comparator
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Patients who received 0.9% saline | |||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Levobuvicaine
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Received IMP | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 2% | ||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
28 Sep 2009 |
Details unknown, the amendment was pre-approval. |
||||||
01 Mar 2011 |
Text regarding the target patient number was inserted. Clarification of the solution to be used. Clarification of the randomisation and dispensing method. |
||||||
22 Jan 2013 |
No documents changed. Temporary halt while replacement PI found. |
||||||
30 Jul 2013 |
Change of PI from Professor Killick to Mr Phillips. |
||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |