Clinical Trial Results:
Quadratus lumborum 3 block (QLB3) for laparoscopic colorectal surgery: A double blind, prospective randomized placebo-controlled trial.
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Summary
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EudraCT number |
2019-002304-40 |
Trial protocol |
BE |
Global end of trial date |
24 Jul 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Aug 2023
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First version publication date |
19 Aug 2023
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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 |
SC05-2019
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
University of Leuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium,
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Public contact |
anesthesiology research, University hospitals Leuven, christel.huygens@uzleuven.be
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Scientific contact |
anesthesiology research, University hospitals Leuven, christel.huygens@uzleuven.be
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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 |
12 Dec 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Jul 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Jul 2022
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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 goal of this study is to improve pain management, minimize the need for postoperative opioids and to facilitate postoperative recovery after laparoscopic colorectal surgery. Our hypothesis is that a bilateral single shot QLB 3 block with 30mL ropivacaine 0,375% on each side is associated with a reduction in postoperative morphine consumption as compared to normal saline 0,9%. Superiority of the QLB 3 block will be defined as a 30% reduction in the cumulative 24-hour morphine consumption post-surgery.
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Protection of trial subjects |
Postoperatively, all patients received multimodal intravenous analgesia including paracetamol, ketorolac and patient-controlled analgesia (PCIA) with morphine.
Rescue medication consisted of clonidine, metamizole and ketamine.
Patiënts received PCIA up unto 24 hours after surgery. Paracetamol and morphine was given after stopping PCIA.
Follow-up till discharge and evaluation of pain scores were standardised.-surgery.
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Background therapy |
Irrespective of any group allocation every patient received 0.1-0.2 mg/kg morphine at extubation and end surgery. At transfer PACU after surgery all patients received the PCIA and with evaluation of painscores extra clinical bolus of Morphine 2 mg was given if NRS > 4 All standard multimodal analgesia was given (ketorolac, paracetamol) | ||
Evidence for comparator |
No big multicenter trails were conducted yet to evaluate the QLB in laparoscopic colorectal surgery. A few small trials however detected advantage in caesarian section and kidney surgery. Given the anatomic basis and the possibility to give analgesia over a larger portion of the abdominal wall, investigation seems mandatory | ||
Actual start date of recruitment |
16 Sep 2019
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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 |
Belgium: 150
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Worldwide total number of subjects |
150
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EEA total number of subjects |
150
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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) |
84
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From 65 to 84 years |
66
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85 years and over |
0
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Recruitment
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Recruitment details |
From november 29, 2019 till 21st of July 2022 a total of 173 patients were screened in Leuven and 158 in Kortrijk. Eventually 150 patients were enrolled, 100 in Leuven and 50 in Kortrijk. | |||||||||
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Pre-assignment
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Screening details |
all consecutive patients between 18 and 75 years of age scheduled for elective laparoscopic colorectal surgery were screened for potential enrolment. Inclusion criteria were American Society of Anesthesiologists (ASA) classification of physical status I-III, a body mass index (BMI) ≤ 35, and the ability to understand the use of PCIA | |||||||||
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Period 1
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Period 1 title |
Surgery (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, Carer, Assessor | |||||||||
Blinding implementation details |
Patients were randomized using a computer-generated permuted block randomization sequence (variable block size with 1:1 allocation). Enclosing assignments in opaque, sequentially numbered, sealed envelopes ensured allocation concealment. Prior to anesthesia, upon arrival in the preoperative holding area, the randomization envelope was opened and medication was prepared by an independent member of the research team not involved in the study or subject’s care. Syringes labeled as trial medication
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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 |
The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375%. | |||||||||
Arm type |
Placebo | |||||||||
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 |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375% at QLB interfascial plane
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Arm title
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Control | |||||||||
Arm description |
The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed 2x30ml normal saline 0,9% at the QLB fascia plane | |||||||||
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 |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
2x30ml normal saline 0,9% at QLB interfascial plane
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375%. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed 2x30ml normal saline 0,9% at the QLB fascia plane | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Control
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Analysing QLB on postoperative pain
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Subject analysis set title |
Intervention
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The coefficient of variation (CV) in postoperative morphine consumption was assumed to equal 0.7 and derived from own data.[6] To have 80% power to show a 30% reduction in the 24-h consumption in the ropivacaine group versus the placebo group using a two-sided test for a ratio of means (with alpha = 5%), at least 51 patients per group were needed (i.e., 102 patients in total). The total number of subjects was increased to 128 to have also at least 80% power in a secondary analysis to detect an effect of ropivacaine within the subgroup of patients with a BMI ≤ 30 (this group was expected to constitute 80% of the total sample). In order to compensate for possible dropouts we included 150 patients in total.
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375%. | ||
Reporting group title |
Control
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Reporting group description |
The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed 2x30ml normal saline 0,9% at the QLB fascia plane | ||
Subject analysis set title |
Control
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Analysing QLB on postoperative pain
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Subject analysis set title |
Intervention
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The coefficient of variation (CV) in postoperative morphine consumption was assumed to equal 0.7 and derived from own data.[6] To have 80% power to show a 30% reduction in the 24-h consumption in the ropivacaine group versus the placebo group using a two-sided test for a ratio of means (with alpha = 5%), at least 51 patients per group were needed (i.e., 102 patients in total). The total number of subjects was increased to 128 to have also at least 80% power in a secondary analysis to detect an effect of ropivacaine within the subgroup of patients with a BMI ≤ 30 (this group was expected to constitute 80% of the total sample). In order to compensate for possible dropouts we included 150 patients in total.
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End point title |
Morphine consumption 24 hours | ||||||||||||
End point description |
Primary outcome was the cumulative morphine consumption during the first 24 hours after extubation. Secondary outcomes included severity of pain, presence/extent of sensory block, the incidence of post-operative nausea and vomiting as well as recovery and hospital length of stay. We also investigated the need for and dose of rescue analgesia. Safety outcomes included the incidence of adverse events.
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End point type |
Primary
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End point timeframe |
Morphine during the first 24 hours using PCIA
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Statistical analysis title |
Primary outcome | ||||||||||||
Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
150
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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| Notes [1] - For the primary outcome, a two-sided independent t-test was used for the difference as well as for for the ratio of the geometric means to compare the 24-h cumulative morphine intake between both groups. A 95% confidence interval for the difference and for the ratio of the geometric means was reported. Secondary outcomes were compared using Fisher’s exact test for proportions, and Mann-Whitney U tests were used when data were measured on a ratio or ordinal level. P-values smaller than 0.05 were |
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End point title |
Pain scores | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
NRS pain scores during 4 hour time frame in PACU and the wards untill discharge
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Safety | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
All adverse events and safety points (nausea, redo surgery, bleeding, systemic toxicity)
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From enrollment until discharge of the patient
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Assessment type |
Systematic | |||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
25
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Before induction of anesthesia, patients received a bilateral AQLB in the left and right lateral decubitus position under ultrasound guidance 30 ml of either ropivacaine 0.375% (n=75) | |||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||
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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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15 Mar 2022 |
Amendment 1 and 2
Adding extra center (Kortrijk)
Increasing age
Adjusting inclusion criteria (ifo Liver and kidney function)
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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. | |||
| None reported | |||
