Clinical Trial Results:
Transversus abdominis plane blok, continous systemic administration of lidocain and patient controlled intravenous morphine - 3 methods for postoperative pain control after laparoscopic colorectal surgery: a randomised comparative trial.
Summary
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EudraCT number |
2014-001499-73 |
Trial protocol |
BE |
Global end of trial date |
16 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jan 2020
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First version publication date |
01 Jan 2020
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Other versions |
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 |
GDW04/2014Amendment1
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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 |
Univeristy Hospitals Leuven
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Sponsor organisation address |
herestraat, leuven, Belgium,
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Public contact |
Anesthesie Research, Univeristy Hospitals Leuven, +32 16344620, christel.huygens@uzleuven.be
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Scientific contact |
Anesthesie Research, Univeristy Hospitals Leuven, +32 16344620, 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 |
17 Mar 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Jan 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jan 2017
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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 |
Does a TAP-block offers superior analgesia in comparison with systemic administation of linisol after laparoscopic colo-rectal surgery.
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Protection of trial subjects |
To prevent patient discomfort and distress, adequate follow-up and treatment was described in the protocol.
"Postoperative pain in the PACU and on the ward was treated with acetaminophen (15 mg/kg 4/day) and ketorolac (0.5mg/kg 3/day) using a fixed scheme. In addition, each patient received patient-controlled intravenous analgesia (PCIA) with morphine. If the postoperative numeric rating scale (NRS) for pain exceeded 3, an additional bolus of 1 mg of morphine (IV) was given on the PACU. If pain treatment was still insufficient, a clonidine bolus (1µg/kg) was given. PONV prophylaxis was performed with IV dexamethasone and IV ondansetron. PONV rescue treatment consisted of IV-droperidol (PACU) or IV-ondansetron (on the ward)."
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Jul 2014
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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: 125
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Worldwide total number of subjects |
125
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EEA total number of subjects |
125
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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) |
87
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From 65 to 84 years |
38
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85 years and over |
0
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Recruitment
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Recruitment details |
between December 2014 and January 2017 | ||||||||||||
Pre-assignment
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Screening details |
125 patients undergoing laparoscopic colorectal surgery were included in this randomized, double-blind controlled clinical trial, patients were randomly allocated to either the quadratus lumborum group (QL-group)(n=50), the lidocaine group (L-group)(n=50) or the placebo group (P-group)(n=25) | ||||||||||||
Pre-assignment period milestones
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Number of subjects started |
125 | ||||||||||||
Number of subjects completed |
125 | ||||||||||||
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 | ||||||||||||
Blinding implementation details |
To attain blinding of the patients and the investigators, patients in the QL-group and the P-group received a perioperative placebo infusion with saline at the same rate as the lidocaine infusion in the L-group. Moreover, the patients of both the L-group and the P-group received also a QL-block with saline.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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QL-group | ||||||||||||
Arm description |
Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Ropivacain
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Perineural use
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Dosage and administration details |
In patients of the QL-group, a bilateral single shot QL-block was applied under ultrasound guidance before induction of anesthesia. At each side, 30 mL (in patients weighing > 55 kg) or 20 mL (in patients weighing < 55 kg) of ropivacaine 0.25% and clonidine 0.5 µg kg-1 were injected using a 22G needle of 50mm length.
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Arm title
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L-group | ||||||||||||
Arm description |
Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo) | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Lidocain
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patients in the L-group received an intravenous (IV) bolus injection of lidocaine 1.5 mg kg 1 at induction of anesthesia followed by a continuous infusion of 1.5 mg kg-1h-1 which was continued until 4h after arrival at the postoperative anesthesia care unit (PACU).
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Arm title
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Control | ||||||||||||
Arm description |
Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group). | ||||||||||||
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 infusion
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Routes of administration |
Perineural use, Intravenous use
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Dosage and administration details |
To attain blinding of the patients and the investigators, patients in the QL-group and the P-group received a perioperative placebo infusion with saline at the same rate as the lidocaine infusion in the L-group. Moreover, the patients of both the L-group and the P-group received also a QL-block with saline.
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Baseline characteristics reporting groups
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Reporting group title |
QL-group
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Reporting group description |
Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
L-group
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Reporting group description |
Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
QL-group
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Reporting group description |
Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg | ||
Reporting group title |
L-group
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Reporting group description |
Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo) | ||
Reporting group title |
Control
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Reporting group description |
Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group). |
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End point title |
Cumulative morphine usage | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 hours after surgery
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Statistical analysis title |
Cumulative morphine consumption | ||||||||||||||||
Statistical analysis description |
Cumulative morphine consumption the first 24 hours postoperatively
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Comparison groups |
QL-group v L-group
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.15 | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Confidence interval |
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End point title |
Recovery of bowel movement | ||||||||||||||||
End point description |
Time until defecation
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End point type |
Secondary
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End point timeframe |
Day of discharge (chart review)
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Statistical analysis title |
Time until defecation | ||||||||||||||||
Comparison groups |
QL-group v L-group v Control
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.84 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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End point title |
Incidence of postoperative nausea and vomiting | ||||||||||||||||||||
End point description |
Incidence of PONV during first 24 hours postoperatively
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End point type |
Secondary
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End point timeframe |
24 hours after surgery
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Statistical analysis title |
incidence of PONV | ||||||||||||||||||||
Comparison groups |
QL-group v L-group v Control
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||||||
P-value |
= 0.578 | ||||||||||||||||||||
Method |
Fisher exact | ||||||||||||||||||||
Confidence interval |
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End point title |
Lenght of hospital stay | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day of discharge
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Statistical analysis title |
Length of hospital stay | ||||||||||||||||
Comparison groups |
QL-group v L-group v Control
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.73 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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End point title |
Clavien-Dindo Classification | ||||||||||||||||
End point description |
Inhospital morbidity with the Clavien Dindo classification
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End point type |
Secondary
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End point timeframe |
Day of discharge
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Statistical analysis title |
Clavien Dindo classification | ||||||||||||||||
Comparison groups |
QL-group v L-group v Control
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.908 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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End point title |
Cytokine IL-6 day 1 | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 after surgery
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Statistical analysis title |
Cytokine IL-6 Day 1 | ||||||||||||||||
Comparison groups |
QL-group v L-group v Control
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.52 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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End point title |
CRP | ||||||||||||||||
End point description |
C-reactive protein as inflammatory parameter at postoperative day 1
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End point type |
Secondary
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End point timeframe |
Day 1 after surgery
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Statistical analysis title |
CRP day 1 | ||||||||||||||||
Comparison groups |
QL-group v L-group v Control
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.31 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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End point title |
Total number of morphine boli | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At removal of PCIA system
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Statistical analysis title |
Delivered morphine boli | ||||||||||||||||||||||||
Comparison groups |
QL-group v L-group v Control
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Number of subjects included in analysis |
125
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||||||||||
P-value |
= 0.005 | ||||||||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Start: Enrollment
Stop: Until hospital discharge
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
QL-group
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Reporting group description |
Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
L-group
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Reporting group description |
Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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14 Oct 2014 |
1) Quadratus lumborum approach for TAP block
2) Time of TAP block at induction
3) Dosage of local anaesthetics
4) Timepoint blood sample
5) Serum ropivacain and lidocain measurement |
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20 Jan 2015 |
TAP block placement at induction with all patients (for the L-group and control, saline will be used) |
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22 Dec 2015 |
Lidocain determination on tissue that was isolated during surgery. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30004914 |