Clinical Trial Results:
Ultrasoundguided Transmuscular Quadratus Lumborum(TQL) block for hand assisted laparoscopic nephrectomy - a randomized controlled trial
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Summary
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EudraCT number |
2017-002130-23 |
Trial protocol |
DK |
Global end of trial date |
31 Jul 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
06 May 2021
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First version publication date |
06 May 2021
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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 |
TQLnephrectomi_v_1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
ZUH
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Sponsor organisation address |
Sygehusvej 1, Roskilde, Denmark, 4000
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Public contact |
Jens Børglum, Dept of Anesth. Zealand university hospital Roskilde, 45 30700112, jedn@regionsjaelland.dk
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Scientific contact |
Jens Børglum, Dept of Anesth. Zealand university hospital Roskilde, 45 30700112, 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 |
20 May 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Jul 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jul 2019
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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 demonstrate whether a unilateral USG TQL block can reduce opioid consumption with clinical significance in kidney cancer patients operated with hand ass. lap nephrectomy
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Protection of trial subjects |
It wasmonitored by the Good Clinical Practice Unit at Copenhagen
University Hospital affiliated to the Danish Health Authority and all data was protected accordingly to the danish data protection agency
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2017
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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: 48
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Worldwide total number of subjects |
48
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EEA total number of subjects |
48
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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) |
20
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From 65 to 84 years |
28
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85 years and over |
0
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Recruitment
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Recruitment details |
Seventy-eight subjects were screened for eligibility from June 2018 to July 2019. Twenty patients did not meet inclusion criteria and eight patients declined to participate. After informed consent, 50 patients were enrolled and randomized | |||||||||
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Pre-assignment
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Screening details |
patients ≥18 years of age,ASA I-III, elective hand-assisted laparoscopic nephrectomy or laparoscopic robot-assisted partial nephrectomy. Exclusion: inability to cooperate, dementia, allergy to LA and opioids, regular daily opioid requirements, abuse of alcohol or medication, local infection at the site of injection, pregnancy | |||||||||
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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 | |||||||||
Blinding implementation details |
After a computer-generated randomization list with five blocks
of 10 with a 1:1 ratio, 50 opaque sealed envelopes numbered 1–50
were prepared. Patients were assigned to receive a
preoperative bilateral TQL block with either 60 mL 0.375%
ropivacaine (intervention) or 60 mL isotonic saline (control).Following inclusion, two research assistants, with no further
involvement in the study, prepared the syringes. All other investigators, staff and patients were blinded
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
Patients received a preoperative bilateral TQL block with 60 mL 0.375% ropivacaine. | |||||||||
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
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Routes of administration |
Infiltration
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Dosage and administration details |
60 mL 0.375% ropivacaine (intervention) or 60 mL isotonic saline (control).
The total dosage of ropivacaine was chosen according to the
Danish Medicines Agency accepted dosage of ropivacaine for a
single-shot block, previous pharmacokinetic studies regarding
the dosage of ropivacaine and two former RCTs using the same
dosage.
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Arm title
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Control | |||||||||
Arm description |
Patients were assigned to receive a preoperative bilateral TQL block with 60 mL isotonic saline (control). | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Infiltration
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Dosage and administration details |
60 mL of Saline was injected( 30 mL bilaterally)
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Patients received a preoperative bilateral TQL block with 60 mL 0.375% ropivacaine. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
Patients were assigned to receive a preoperative bilateral TQL block with 60 mL isotonic saline (control). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Patients received a preoperative bilateral TQL block with 60 mL 0.375% ropivacaine. | ||
Reporting group title |
Control
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Reporting group description |
Patients were assigned to receive a preoperative bilateral TQL block with 60 mL isotonic saline (control). | ||
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End point title |
Postoperative opioid 0-12 hours | ||||||||||||
End point description |
When entering the PACU, a protocol trained nurse connected the intravenous
PCA pump to one of the two intravenous lines. If the
NRS score was ≥4 despite the use of PCA morphine, additional
intravenous morphine could be required, and the administration
hereof was recorded in the patient’s electronic file. Intravenous
morphine was converted to OME in the ratio 1:3.13
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End point type |
Primary
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End point timeframe |
0-12 hours postoperatively
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Statistical analysis title |
Overall Statistical analysis | ||||||||||||
Statistical analysis description |
Data were analyzed using SAS V.9.4. Normal distribution was tested using Q-Q plots. We summarized continuous
data using mean, CIs, median and IQR and assessed difference between groups using t tests and Mann-Whitney-Wilcoxon
test on both raw and transformed data including integrated average scores. Time-to-event data were analyzed using Kaplan-Meier curves and log-rank tests and data were presented as median (IQR). Frequencies were quantitated and analyzed using χ2tests or Fischer’s exact test
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
48
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 [1] | ||||||||||||
Method |
Fisher exact | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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95% | ||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||
upper limit |
- | ||||||||||||
Variability estimate |
Standard error of the mean
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| Notes [1] - level of significance (a)=0.05 (two-sided) and power 80% (1−β) |
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End point title |
Postoperative opioid 12-18 | ||||||||||||
End point description |
T0 was defined as arrival time in the PACU. Consequently, when
entering the PACU, a protocol trained nurse connected the intravenous
PCA pump to one of the two intravenous lines. If the
NRS score was ≥4 despite the use of PCA morphine, additional
intravenous morphine could be required, and the administration
hereof was recorded in the patient’s electronic file. Intravenous
morphine was converted to OME in the ratio 1:3
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End point type |
Secondary
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End point timeframe |
accumulated OME consumption (mg) at 12–18 hours
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| No statistical analyses for this end point | |||||||||||||
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End point title |
NRS at activity | ||||||||||||
End point description |
Pain scores (NRS) at (1) rest and at (2) activity were assessed
at predefined time points from T0 to T24 hours.
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End point type |
Secondary
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End point timeframe |
0-24 hours
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| No statistical analyses for this end point | |||||||||||||
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End point title |
NRS at rest | ||||||||||||
End point description |
Pain scores (NRS) at (1) rest and at (2) activity were assessed
at predefined time points from T0 to T24 hours.
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End point type |
Secondary
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End point timeframe |
0-24 hours postoperatively
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Pain related to block procedure | ||||||||||||
End point description |
Pain scores during block procedure
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End point type |
Secondary
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End point timeframe |
preoperatively
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Statistical analysis title |
Overall Statistical analysis | ||||||||||||
Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
48
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Fisher exact | ||||||||||||
Confidence interval |
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End point title |
Time to ambulate | ||||||||||||
End point description |
Time to first ambulation was defined as time from T0 until
the patient was able to stand on the floor and independently
walk.
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End point type |
Secondary
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End point timeframe |
0-24 hours
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| No statistical analyses for this end point | |||||||||||||
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End point title |
LOS | ||||||||||||
End point description |
Based on the hospital’s standard discharge criteria for laparoscopic
nephrectomies, the surgeons decided when to discharge
the patients and recorded this in the patient’s electronic file.
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End point type |
Secondary
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End point timeframe |
until discharge
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to first opioid demand | ||||||||||||
End point description |
Time to first
opioid demand was defined as time from T0 until the first PCA
bolus.
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End point type |
Secondary
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End point timeframe |
0-24 hours
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| No statistical analyses for this end point | |||||||||||||
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End point title |
nausea and vomiting | ||||||||||||
End point description |
nausea and vomiting (yes/no),
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End point type |
Secondary
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End point timeframe |
0-24 hours
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Postoperative opioid 18-24 | ||||||||||||
End point description |
accumulated OME consumption (mg) at 18–24 hours,
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End point type |
Secondary
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End point timeframe |
18-24 postoperatively
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| No statistical analyses for this end point | |||||||||||||
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End point title |
total OME 24 hours | ||||||||||||
End point description |
total accumulated OME consumption (mg) at 0-24 hours
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End point type |
Secondary
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End point timeframe |
0-24 hours
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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 |
The entire study period
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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, AE | ||||||||||
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 |
- | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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. | |||
| No evaluation of block succes | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/33106280 |
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