Clinical Trial Results:
Erector spinae plane (ESP) block versus intercostal nerve blocks (ICNB) in uniportal videoscopic assisted thoracic surgery (VATS): A multicenter double-blind, prospective, randomized controlled trial.
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Summary
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EudraCT number |
2021-006201-29 |
Trial protocol |
BE |
Global end of trial date |
23 Feb 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Aug 2024
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First version publication date |
14 Aug 2024
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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 |
SC102021
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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 |
UZ Leuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium,
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Public contact |
Research anesthesie, University Hopitals Leuven, +32 16344270, steve.coppens@uzleuven.be
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Scientific contact |
Research anesthesie, Anesthesie, +32 16344270, steve.coppens@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 |
05 Jun 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Feb 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Feb 2024
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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 compare the efficacy of the erector spinae block with the intercostal nerve block.
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Protection of trial subjects |
All source data will be kept at a secured location with restricted access at all times. These data must
be collected and processed with adequate precautions to ensure confidentiality and compliance with
applicable data protection laws and regulations and more in particular the EU General Data Protection
Regulation 2016/679 (GDPR) and relevant national laws implementing the GDPR. Appropriate
technical and organizational measures to protect the data against unauthorized disclosure or access,
accidental or unlawful destruction, or accidental loss or alteration must be established. Trial staff
whose responsibilities require access to personal data agree to keep the data confidential.
The Investigator and the Participating Site(s) (as applicable) shall treat all information and data relating
to the Trial disclosed to them as confidential and shall not disclose such information to any third parties
or use such information for any purpose other than the objectives of the Trial as described in this
protocol. The collection, processing and disclosure of personal data, such as participant health and
medical information is subject to compliance with applicable laws and regulations regarding personal
data protection and the processing of personal data
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Background therapy |
3.7 Concomitant medication (non-IMP) During the perioperative phase until 24 hours postoperatively, standard multimodal analgesia will consist of paracetamol 15mg/kg IV 4q and metamizole 1000 mg IV 4 q and morphine IV loading dose of 0,1 mg/kg. Patient Controlled Intravenous Analgesia (PCIA) with morphine (lockout 1.5mg every 7 minutes, with a maximum dose of 30mg over 4 hours) will be initiated in the PACU. Co-analgesic drugs that may affect postoperative pain levels such as intravenous lidocaine, gabapentinoids, ketamine, clonidine-hydrochloride and tramadol are not allowed (except in case of rescue treatment, see below). 3.8 Rescue treatment In case of severe postoperative pain despite adequate use of the morphine PCIA, an extra bolus of morphine can be given IV until adequate pain levels (NRS ≤ 3) are reached (1-2 mg IV up to 0,1-0,2 mg/kg). In case of persistent pain and NRS scores ≥ 6, rescue medication will be initiated. In addition, a bolus of ketamine 0.1 mg/kg IV will be titrated. In case of insufficient effects and a persistent NRS ≥ 6, a bolus of clonidine 1 to 2 µg/kg can be given IV. | ||
Evidence for comparator |
The current lack of evidence surrounding the ESP, warrants further investigation. Furthermore, there is a general calling for well-designed robust multicenter prospective randomized control trials regarding the ESP. (25) Next to the scarcity of evidence some other problems regarding the ESP block concern us. Specific regional anesthesia training and expensive resources are required to perform the block safely. Like all fascial plane blocks, which are volume dependent blocks, systemic toxicity is a real danger. In addition the ESP block requires meticulous timing and adjusting operative schedule if it is pre-emptively placed in an awake patient. A fully equipped block room and staffing is needed. If placed intra-operatively, during general anesthesia, additional time is required to use ultrasound, position the patient and to effectively block using regional anesthesia disposable trays and equipment. We therefor hypothesize that a simple well-known, tried and tested block like the ICNB, easily performed by the surgeon intra-operatively is more cost-effective and superior to the ESP block. Currently, to our knowledge, there is only one active study (single center) comparing ICNB versus ESP block for VATS surgery (Erector Spinae Plane Block Versus Intercostal for VATS - Full Text View - ClinicalTrials.gov). | ||
Actual start date of recruitment |
18 Apr 2022
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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: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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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) |
60
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From 65 to 84 years |
40
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85 years and over |
0
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Recruitment
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Recruitment details |
From March 2022 to February 2024, 124 patients were assessed for eligibility in both study centers. | |||||||||
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Pre-assignment
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Screening details |
Eligibility: all patient is scheduled for elective single port video thoracoscopic surgery age between 18-80 and BMI below 40, ASA I- IV without chronic pain medication or liver and kidney function impairment | |||||||||
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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 |
Investigator, Monitor, Assessor, Subject | |||||||||
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. At the end of surgery, the randomization envelope was opened and trial medication was prepared by an independent member of the research team not involved in the study or subject’s care. Syringes were labelled as “trial medication”, to guarantee blinding
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ICB active (ESP Placebo) | |||||||||
Arm description |
The intercostal nerve blocks were performed by experienced surgeons at the end of surgery utilizing a small intramuscular needle attached to an intravenous line with syringe mounted on a thoracoscopic clamp. (Fig. 1) They infiltrated 6-7 different intercostal spaces dividing the 30 ml trial medication (30 ml ropivacaine 0,5% ) over each segment. The erector spinae plane block was placed at the end of surgery in lateral decubitus prior to reversal of anesthesia. A high-frequency 10-13 MHz linear ultrasound transducer (C 60Xi Fujifilm, Bothell USA), connected to a high-resolution ultrasound machine (Sonosite SII, Fujifilm, Bothell USA), was placed at T5-T6 to evaluate the rhomboid and trapezius muscles inceting 30 ml trial medication (30 ml saline 0.9% placebo) | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Ropivacaine 0.5% and Saline 0.9%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
30 ml ropivacaine and 30 ml saline 0.9%
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Investigational medicinal product name |
Saline 0.9% and Ropivacaine 0.5%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
30 ml ropivacaine and 30 ml saline 0.9%
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Arm title
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ESP active (ICB placebo) | |||||||||
Arm description |
The intercostal nerve blocks were performed by experienced surgeons at the end of surgery utilizing a small intramuscular needle attached to an intravenous line with syringe mounted on a thoracoscopic clamp. (Fig. 1) They infiltrated 6-7 different intercostal spaces dividing the 30 ml trial medication (30 ml ropivacaine 0,9% saline ) over each segment. The erector spinae plane block was placed at the end of surgery in lateral decubitus prior to reversal of anesthesia. A high-frequency 10-13 MHz linear ultrasound transducer (C 60Xi Fujifilm, Bothell USA), connected to a high-resolution ultrasound machine (Sonosite SII, Fujifilm, Bothell USA), was placed at T5-T6 to evaluate the rhomboid and trapezius muscles inceting 30 ml trial medication (30 ml 0.5% ropivacaine) | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Saline 0.9%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infiltration
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Dosage and administration details |
Saline 0.9% 30 ml
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Investigational medicinal product name |
ropivacaine 0.5%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Infiltration
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Dosage and administration details |
ropivacein 0.5% 30 ml
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Baseline characteristics reporting groups
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Reporting group title |
ICB active (ESP Placebo)
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Reporting group description |
The intercostal nerve blocks were performed by experienced surgeons at the end of surgery utilizing a small intramuscular needle attached to an intravenous line with syringe mounted on a thoracoscopic clamp. (Fig. 1) They infiltrated 6-7 different intercostal spaces dividing the 30 ml trial medication (30 ml ropivacaine 0,5% ) over each segment. The erector spinae plane block was placed at the end of surgery in lateral decubitus prior to reversal of anesthesia. A high-frequency 10-13 MHz linear ultrasound transducer (C 60Xi Fujifilm, Bothell USA), connected to a high-resolution ultrasound machine (Sonosite SII, Fujifilm, Bothell USA), was placed at T5-T6 to evaluate the rhomboid and trapezius muscles inceting 30 ml trial medication (30 ml saline 0.9% placebo) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ESP active (ICB placebo)
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Reporting group description |
The intercostal nerve blocks were performed by experienced surgeons at the end of surgery utilizing a small intramuscular needle attached to an intravenous line with syringe mounted on a thoracoscopic clamp. (Fig. 1) They infiltrated 6-7 different intercostal spaces dividing the 30 ml trial medication (30 ml ropivacaine 0,9% saline ) over each segment. The erector spinae plane block was placed at the end of surgery in lateral decubitus prior to reversal of anesthesia. A high-frequency 10-13 MHz linear ultrasound transducer (C 60Xi Fujifilm, Bothell USA), connected to a high-resolution ultrasound machine (Sonosite SII, Fujifilm, Bothell USA), was placed at T5-T6 to evaluate the rhomboid and trapezius muscles inceting 30 ml trial medication (30 ml 0.5% ropivacaine) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
ESP active (ICB Placebo)
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
morphine consumption and NRS pain scores over 24 hours
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Subject analysis set title |
ICB active (ESP Placebo)
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Morphine consumption and pain scores NRS over 24 hours
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End points reporting groups
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Reporting group title |
ICB active (ESP Placebo)
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Reporting group description |
The intercostal nerve blocks were performed by experienced surgeons at the end of surgery utilizing a small intramuscular needle attached to an intravenous line with syringe mounted on a thoracoscopic clamp. (Fig. 1) They infiltrated 6-7 different intercostal spaces dividing the 30 ml trial medication (30 ml ropivacaine 0,5% ) over each segment. The erector spinae plane block was placed at the end of surgery in lateral decubitus prior to reversal of anesthesia. A high-frequency 10-13 MHz linear ultrasound transducer (C 60Xi Fujifilm, Bothell USA), connected to a high-resolution ultrasound machine (Sonosite SII, Fujifilm, Bothell USA), was placed at T5-T6 to evaluate the rhomboid and trapezius muscles inceting 30 ml trial medication (30 ml saline 0.9% placebo) | ||
Reporting group title |
ESP active (ICB placebo)
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Reporting group description |
The intercostal nerve blocks were performed by experienced surgeons at the end of surgery utilizing a small intramuscular needle attached to an intravenous line with syringe mounted on a thoracoscopic clamp. (Fig. 1) They infiltrated 6-7 different intercostal spaces dividing the 30 ml trial medication (30 ml ropivacaine 0,9% saline ) over each segment. The erector spinae plane block was placed at the end of surgery in lateral decubitus prior to reversal of anesthesia. A high-frequency 10-13 MHz linear ultrasound transducer (C 60Xi Fujifilm, Bothell USA), connected to a high-resolution ultrasound machine (Sonosite SII, Fujifilm, Bothell USA), was placed at T5-T6 to evaluate the rhomboid and trapezius muscles inceting 30 ml trial medication (30 ml 0.5% ropivacaine) | ||
Subject analysis set title |
ESP active (ICB Placebo)
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
morphine consumption and NRS pain scores over 24 hours
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Subject analysis set title |
ICB active (ESP Placebo)
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Morphine consumption and pain scores NRS over 24 hours
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End point title |
Morphine consumption 12 hours | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Assessed 12 hours post intubation
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Statistical analysis title |
Primary Outcome | ||||||||||||
Comparison groups |
ICB active (ESP Placebo) v ESP active (ICB placebo)
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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 |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Variability estimate |
Standard deviation
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End point title |
Morphine consumption 24 hours | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Assessed 24 hours after extubation
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Statistical analysis title |
Key Secondary outcome | ||||||||||||
Comparison groups |
ICB active (ESP Placebo) v ESP active (ICB placebo)
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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 |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
From enrollment until 24 after extubation
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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 |
Active ICB (ESP Placebo)
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Reporting group description |
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Reporting group title |
Active ESP (ICB Placebo)
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 | |||
