Clinical Trial Results:
Comparison of continuous paravertebral blockade (PVB) and continuous thoracic epidural analgesia (TEA) for analgesia following open renal surgery
|
Summary
|
|
EudraCT number |
2008-004998-17 |
Trial protocol |
IE |
Global end of trial date |
22 Nov 2010
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
22 Oct 2022
|
First version publication date |
22 Oct 2022
|
Other versions |
|
Summary report(s) |
Comparison of the analgesic efficacy and side effect profile of continuous epidural analgesia and paravertebral blockade with patient controlled analgesia in patients undergoing Open Renal Surgery Postoperative Morphine consumption Postoperative Pain scores Postoperative heart rate and mean arterial pressure Intraoperative heart rate and mean arterial pressure Distributon of sensory block postoperatively |
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 |
0none
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Dept Anaesthesia, UCHG
|
||
Sponsor organisation address |
Newcastle Rd, Galway, Ireland, H91YR71
|
||
Public contact |
DR OliviaFinnerty, Dept Anaesthesia, UCHG, +353 91544074, olivia.finnerty@hse.ie
|
||
Scientific contact |
Dr Olivia Finnerty., Dept Anaesthesia, UCHG, +353 91544074, anaesthesia.guh@hse.ie
|
||
|
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 |
20 Jun 2011
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
19 Nov 2010
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
22 Nov 2010
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
We aim to compare the analgesic efficacy of paravertebral and epidural blockage, for post operative pain in the first 24 post operative hours, following open renal surgery.
1. Severity of Postoperative Pain, [VAS and Categorical pain Scales]
2. Total opiate usage in the first 48 hours after surgery
|
||
Protection of trial subjects |
The trial subjects were reassured they could discontinue involvement in the study at any time.
The main trial researcher OF was available by telephone or in person to assist concerns about analgesia, data collection or privacy etc.
|
||
Background therapy |
Intravenous paracetamol was given to both study groups. | ||
Evidence for comparator |
A multimodal postoperative pain treatment regimen that provides high quality analgesia with minimal side effects is ideal. Epidural analgesia is the gold standard for laparotomy [2,3] and hence open renal procedures, but may not be available either due to the patient’s characteristics or due to staff or equipment shortages. Where epidural analgesia is not available or contra-indicated, high amounts of opioid analgesia, is usually required. However the heavy use of opioids can result in significant adverse effects, including sedation, nausea and vomiting [4]. These, coupled with the reactive pleural effusion on the side of surgery, contribute significantly to respiratory morbidity [5]. Epidural analgesia may result in vasodilatation, leading to increased postoperative haemodynamic instability, motor block and increased nursing workload [6]. Alternative approaches, which reduce the requirement for strong opioids postoperatively, are needed. Paravertebral analgesia has been used successfully for many procedures from cholecystectomy to abdominal vascular surgery [7-9]. Recent reviews conclude that PVB analgesia may be superior to epidural analgesia in maintaining respiratory function following thoracotomy [10-12]. These findings prompted us to commence a trial comparing epidural and PVB analgesia for open renal surgery. 1. Wall PD, Melzack R (chapter title) Wall PD, Melzack R editors. Textbook of Pain. 4th ed. Edinburgh: Churchill Livingstone, 1999:401-28. 2. Werawatganon T, Charuluxananan S. Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004088. DOI: 10.1002/14651858.CD004088.pub2. 3. Block BM, Liu SS, Rowlingson AJ, Cowen AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia; a meta-analysis. Journal of the American Medical Association 2003; 290: 2455-63. 4. Benyamin R, Trescot AM, Datta S, Buenaventur | ||
Actual start date of recruitment |
22 Sep 2008
|
||
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 |
Ireland: 51
|
||
Worldwide total number of subjects |
51
|
||
EEA total number of subjects |
51
|
||
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) |
38
|
||
From 65 to 84 years |
13
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
The patients were invited to participate in the study as soon as they were scheduled for renal surgery through outpatients at University College Hospital Galway between early September 2008 and November 2010. | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
ASA physical status I-III, between 18 and 80 years of age, They were scheduled for open renal surgery. Exclusion criteria: contraindication to neuraxial blockade, local infection at the site of block insertion, relevant drug allergy, concurrent use of MAOIs or use within 2 weeks prior to surgery, sepsis, severe kyphoscoliosis, previous thoracic ve | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Overall trial (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
The patients were randomized in batches of ten, to receive either epidural analgesia (Group E, n = 25) or PVB analgesia with patient controlled intravenous morphine (Group P, n = 26). The allocation sequence was generated by a random number table, and group allocation was concealed in sealed, opaque envelopes, which were not opened until patient consent had been obtained.
|
|||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Paravertebral | |||||||||
Arm description |
This group had PVB analgesia | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Chirocaine
|
|||||||||
Investigational medicinal product code |
PL00037/0300
|
|||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for injection in vial
|
|||||||||
Routes of administration |
Perineural use
|
|||||||||
Dosage and administration details |
0.25% Levobupivacaine. Local anaesthetic for epidural injection.
|
|||||||||
|
Arm title
|
Epidural | |||||||||
Arm description |
This group received epidural analgesia. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Chirocaine
|
|||||||||
Investigational medicinal product code |
PL00037/0300
|
|||||||||
Other name |
Levobupivacaine
|
|||||||||
Pharmaceutical forms |
Solution for injection
|
|||||||||
Routes of administration |
Perineural use
|
|||||||||
Dosage and administration details |
Levobupivacaine 0.25%. Local anaesthetic solution for epidural and perineural use.
|
|||||||||
|
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Paravertebral
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
This group had PVB analgesia | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Epidural
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
This group received epidural analgesia. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Paravertebral
|
||
Reporting group description |
This group had PVB analgesia | ||
Reporting group title |
Epidural
|
||
Reporting group description |
This group received epidural analgesia. | ||
|
|||||||||||||
End point title |
Interim analysis | ||||||||||||
End point description |
The study would be terminated in the event that the analysis of 24-hour morphine consumption demonstrated that morphine consumption was 20% higher in the PVB group, with a p value < 0.01.
The interim analysis demonstrated that morphine consumption was significantly (P < 0.01) greater in the group that received PVB analgesia, disproving the primary hypothesis. The study was terminated at this point and the analysis of the data completed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
This interim analysis was carried out following recruitment of the 51st patient.
|
||||||||||||
|
|||||||||||||
Attachments |
Untitled (Filename: Figure 1 Postoperative Morphine consumption.jpg) |
||||||||||||
Statistical analysis title |
Satistical analysis | ||||||||||||
Statistical analysis description |
All statistical analyses were performed using a standard statistical program (Sigmastat 3.5, Systat Software, San Jose, CA, USA). Demographic data were analyzed using Student’s t or Fisher’s exact tests as appropriate. The data were tested for normality using the Kolmogorov-Smirnov normality test. Repeated measurements (pain scores, nausea scores) were analyzed by repeated measures ANOVA where normally distributed, with further paired comparisons at each time interval performed using the t test.
|
||||||||||||
Comparison groups |
Epidural v Paravertebral
|
||||||||||||
Number of subjects included in analysis |
51
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
equivalence [1] | ||||||||||||
P-value |
< 0.01 [2] | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
|||||||||||||
| Notes [1] - For the purposes of sample size calculation, we assumed that, for PVB blockade to be deemed to provide equivalent analgesia, the 24-hour postoperative morphine requirement could not be greater than 20% higher compared to patients receiving epidural blockade. Based on initial pilot studies we projected a mean 24-hour morphine requirement of 10mg with a standard deviation of 5mg in the epidural group. [2] - The study would be terminated in the event that the analysis of 24-hour morphine consumption demonstrated that morphine consumption was 20% higher in the PVB group, with a p value < 0.01. |
|||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Any adverse events were recorded from the start of anaesthesia of any patient up to 72hours postoperatively or at the end of data collection
|
|||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||
Dictionary name |
Self reporting | |||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
|
|||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Paravertebral
|
|||||||||||||||||||||||||||||||||||||||
Reporting group description |
This group had PVB analgesia | |||||||||||||||||||||||||||||||||||||||
Reporting group title |
Epidural
|
|||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||
Substantial protocol amendments (globally) |
|||||||
| Were there any global substantial amendments to the protocol? No | |||||||
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 | |||||||
