Clinical Trial Results:
Ultrasound-guided Transmuscular Quadratus Lumborum catheters for elective caesarean section.
A double blind, randomised, placebo controlled trial.
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Summary
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EudraCT number |
2017-003625-15 |
Trial protocol |
DK |
Global end of trial date |
08 Apr 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Sep 2022
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First version publication date |
14 Sep 2022
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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 |
Cath_TQL_caesarean_version1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03068260 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Zealand university hospital, Roskilde
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Sponsor organisation address |
Sygehusvej 10, Roskilde, Denmark, 4000
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Public contact |
Jens Børglum, Dept. of Anaesth., Zealand university hospital, Roskilde, 45 30700120, jedn@regionsjaelland.dk
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Scientific contact |
Jens Børglum, Dept. of Anaesth., Zealand university hospital, Roskilde, 45 30700120, jedn@regionsjaelland.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 |
08 Apr 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 Apr 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Apr 2020
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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 aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours, and that bilateral TQL catheters will significantly reduce the Numerical Rating Scale (NRS) pain score (0-10/10) compared to the placebo group.
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Protection of trial subjects |
All participants were treated in accordance to departmental standard of care. The intervention was accepted with a minimum of or no discomfort at all due to the still pain relieving effect of the spinal anaesthesia used for the cesarean section. In addition, all participants were instructed in the use of an ekstra patient-controlled mode of pain relief via the patient-controlled analgesia pump with a morphine medication attached to the indwelling i.v.-line, which was on top of the standard treatment of paracetamol and NSAID's.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2018
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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 |
Denmark: 32
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Worldwide total number of subjects |
32
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EEA total number of subjects |
32
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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) |
32
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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 |
We obtained written informed consent from all patients prior to inclusion, and 32 subjects were enrolled at Zealand University Hospital, Denmark from September 4, 2018 to April 7, 2020 | |||||||||
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Pre-assignment
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Screening details |
Overall, 131 patients were screened for eligibility from August 2018 to April 2020. Following informed consent, 32 participants were enrolled in the study and randomized. No important differences in patient characteristics was observed between the two study groups. | |||||||||
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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 | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo/saline group | |||||||||
Arm description |
Standard treatment of care + placebo, normal saline TQL re-injection and infusion through TQL-catheter. Re-injection was performed 2 hours post-catheter placement and infusion commenced immediately afterwards. | |||||||||
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/infusion
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Routes of administration |
Injection
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Dosage and administration details |
2 (bilateral injections) x 30 mL saline 0,9% at T2 hours + continuous infusion via a Y-connector of saline 0,9% with a flow of 4 mL/hour per catheter.
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Arm title
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Active/ropivacaine TQL re-injection and infusion | |||||||||
Arm description |
Standard treatment of care + active, ropivacaine TQL re-injection and infusion through TQL-catheter. Re-injection was performed 2 hours post-catheter placement and infusion commenced immediately afterwards. | |||||||||
Arm type |
Active comparator | |||||||||
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 |
Injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
2 (bilateral injections) x 30 mL ropivacaine 2 mg/ml at T2 hours (120 mg) + continuous infusion via a Y-connector of 2 mg/ml ropivacaine with a flow of 4 mL/hour per catheter (352 mg in 22 hours).
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo/saline group
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Reporting group description |
Standard treatment of care + placebo, normal saline TQL re-injection and infusion through TQL-catheter. Re-injection was performed 2 hours post-catheter placement and infusion commenced immediately afterwards. | ||
Reporting group title |
Active/ropivacaine TQL re-injection and infusion
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Reporting group description |
Standard treatment of care + active, ropivacaine TQL re-injection and infusion through TQL-catheter. Re-injection was performed 2 hours post-catheter placement and infusion commenced immediately afterwards. | ||
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End point title |
Time to first opioid consumption | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
first 24 hours post primary TQL injection and catheter placement
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Statistical analysis title |
primary end point | ||||||||||||
Statistical analysis description |
Mann-Whitney test
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Comparison groups |
Placebo/saline group v Active/ropivacaine TQL re-injection and infusion
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Number of subjects included in analysis |
27
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.89 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From first intervention and until 24 hours after the last use of study medication.
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Assessment type |
Systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
SUSAR, SAE, SE | ||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Both groups
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Reporting group description |
Both groups | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||
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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: There were no adverse events recored in 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. | |||
| None reported | |||
