Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001296820
Ethics application status
Approved
Date submitted
8/12/2020
Date registered
24/09/2021
Date last updated
24/09/2021
Date data sharing statement initially provided
24/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous erector spinae plane block versus continuous epidural analgesia after thoracic surgery
Scientific title
Evaluation of the efficacy of postoperative analgesia using a continuous erector spinae plane block in comparison with continuous epidural analgesia in patients after thoracic surgery
Secondary ID [1] 302971 0
None
Universal Trial Number (UTN)
U1111-1261-3890
Trial acronym
CESPB-RANDOM
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain 320029 0
Regional Anaesthesia 320030 0
Thoracic surgery 320031 0
Condition category
Condition code
Anaesthesiology 317952 317952 0 0
Pain management
Surgery 317954 317954 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous erector spinae plane block (CESPB) procedure:

Patients will be randomly assigned to two comparison groups. The first group (experimental) will be subjected to a continuous erector spinae plane block (CESPB). The CESPB procedure will be performed on the day of surgery in the operating theatre before general anaesthesia is performed. The CESPB within the chest will be performed at the level of the transverse process of the Th4 or Th5 vertebrae. Identification and creation of space between the erector spine muscle and transverse processes are accomplished by depositing local anaesthetic agents (LA) directly on the transverse process and observation of muscle separation from the transverse process and intercostal muscles. The whole procedure will be ultrasound-guided using the SonoLong Echo kit (PAJUNK Medical Systems, Norcross, United States).

Stages of CESPB anaesthesia:
1. Skin and subcutaneous anaesthesia with 4ml 1% Lignocaine;
2. Identification of the Th4 or Th5 transverse process with a linear ultrasound transducer;
3. "In-plane" insertion of the Touhy cannula with respect to the ultrasound transducer;
4. Identification of the correct needle end position by applying a 0.9% NaCl solution;
5. Creation of space to deposit a continuous infusion catheter with approximately 5 ml 0.9% NaCl solution;
6. Catheter tunnelling, protection of the puncture site with a sterile dressing, the connection of a flow-controlled elastomer pump, and initiation of 0.2% Ropimol infusion rate of 5 mL/hr.
- initiation of the infusion occurs approximately 30 mins prior to the end of the procedure and is preceded by a 10-20 ml bolus injection;
- Ropimol is infused via an elastomeric pump with a predefined flow rate of 5 ml/h and calibrated for an approximate infusion time of 72 hours;
- during that period the patient is strictly monitored for potential side effects, insufficient analgesia, general comfort).

Importantly, during the postoperative period, coanalgesics will be used according to the standard: Paracetamol (Acetaminophen) 1.0 g IV every 6 hours, Metamizole 2.5 g IV every 12 hours, Ketoprofen 100 mg IV every 12 hours.

In case of allergy or any contraindications to the above-mentioned medications, the scheme will be modified and the patient will be excluded from the study. After 48 hours, the CEA/CESPB catheter will be removed.

The person performing the CESPB procedure in the experimental group will be the same anesthesiologist who performs the CEA procedure in the control group with at least 5 years of professional expertise, including a minimum of 100 CEA and 10 CESPB.
Intervention code [1] 319265 0
Treatment: Devices
Intervention code [2] 319266 0
Treatment: Drugs
Intervention code [3] 319267 0
Prevention
Comparator / control treatment
Continuous epidural analgesia (CEA) procedure:

The CEA procedure will be performed on the day of surgery in the operating theatre before general anaesthesia is performed. The CEA block for thoracic surgery will be performed at the level of the Th4-Th5 vertebrae using a Perifix® Braun or EpiLong kit (PAJUNK Medical Systems (Norcross, United States).

Stages of CEA:
1. Skin and subcutaneous anaesthesia with 4ml 1% Lignocaine;
2. Identification of the epidural space using the loss-of-resistance technique;
3. Insertion of the catheter to CEA at a depth of 3.5-4.5 cm into the epidural space calculated from the depth of loss-of-resistance in the piston of the guiding syringe plunger;
4. Administration of a test dose of 3ml of Marcaine with Adrenaline (15 mg Bupivacaine and 15 µg Adrenaline);
5. Catheter tunnelling, protection of the puncture site with a sterile dressing, the connection of a flow-controlled elastomer pump, and initiation of 0.2% Ropimol infusion rate of 5 mL/hr.
- initiation of the infusion occurs approximately 30 mins prior to the end of the procedure and is preceded by a 10-20 ml bolus injection;
- Ropimol is infused via an elastomeric pump with a predefined flow rate of 5 ml/h and calibrated for an approximate infusion time of 72 hours;
- during that period the patient is strictly monitored for potential side effects, insufficient analgesia, general comfort).

The person performing the CEA procedure in the control group will be the same anesthesiologist who performs the CESPB in the experimental group with at least 5 years of professional expertise, including a minimum of 100 CEA and 10 CESPB.
Control group
Active

Outcomes
Primary outcome [1] 325968 0
The severity of pain assessed by the patient by means of the Numerical Rating Scale (NRS).
Timepoint [1] 325968 0
Baseline, postoperative 6 hours, 12 hours (primary timepoint), 18 hours, 24 hours, 36 hours, and 48 hours.
Primary outcome [2] 325969 0
The severity of pain assessed by the patient by means of the Visual Analogue Scale (VAS).
Timepoint [2] 325969 0
Baseline, postoperative 6 hours, 12 hours (primary timepoint), 18 hours, 24 hours, 36 hours, and 48 hours.
Primary outcome [3] 327864 0
The quality of postoperative recovery assessed by the patient by means of the Quality-of-Recovery 15 (QoR-15).
Timepoint [3] 327864 0
Baseline, postoperative 24 hours.
Secondary outcome [1] 389713 0
Requirement for use of coanalgesics by accessing the patient medical record.
Timepoint [1] 389713 0
Baseline, postoperative 6 hours, 12 hours,18 hours, 24 hours, 36 hours, and 48 hours.
Secondary outcome [2] 389714 0
Requirement for use of opioid by accessing the patient medical record.
Timepoint [2] 389714 0
Baseline, postoperative 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, and 48 hours.
Secondary outcome [3] 396802 0
A composite outcome: The level of selected vital signs such as heart rate (HR, measured using an electrocardiograph), blood pressure (BP, measured by measured using a sphygmomanometer), oxygen saturation (SaO2, measured using a pulse oximeter) in the clinical monitoring of hemodynamic stability and effectiveness of anaesthesia.
Timepoint [3] 396802 0
Baseline, intraoperative every 15 minutes of the procedure, and postoperative15 minutes, 30 minutes, 45 minutes, and 60 minutes.
Secondary outcome [4] 396803 0
The incidence of potential side effects and post-operative complications by accessing the patient medical record.
Timepoint [4] 396803 0
Postoperative 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, and 48 hours.

Eligibility
Key inclusion criteria
1. Patients qualified for thoracic surgery
2. Age between 18-80 years old
3. The lack of blood coagulation disorders and the lack of allergy to anaesthetic agents
4. The obtained informed and written consent to participate in the study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The lack of informed consent for CESPB anaesthesia
2. Technical difficulties in the placement of the CEA catheter
3. The patient's condition that makes it unable to complete the questionnaires or continue the research

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e., computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuously distributed data will be tested for normality and measures of central tendency will be analyzed. Normally distributed data will be expressed as means and standard deviations and compared using a Student t-test; non-normally distributed data will be expressed as medians (interquartile range, IQR) and compared using the Mann-Whitney U test. Categorical variables will be described as proportions and compared using the chi-squared test or the Fisher Exact test. The strength of the relationship will be evaluated with the Spearman rank correlation coefficient. All p-values of less than 0.05 will be treated as indicative as statistical significance and no correction for multiplicity of testing will be undertaken due to the exploratory nature of the study. The study will be reported using the CONSORT guidelines. Analyses will be performed using GraphPad Prism (version 7.00 for Mac, GraphPad Software, La Jolla California USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
24/01/2022
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 23283 0
Poland
State/province [1] 23283 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 307389 0
Hospital
Name [1] 307389 0
4th Military Hospital of Wroclaw
Country [1] 307389 0
Poland
Primary sponsor type
Hospital
Name
4th Military Hospital of Wroclaw
Address
Department of Anesthesiology and Intensive Care, Weigla 5, 50-981 Wroclaw, Poland
Country
Poland
Secondary sponsor category [1] 308045 0
Hospital
Name [1] 308045 0
Wroclaw Medical University
Address [1] 308045 0
Department of Anaesthesiology and Intensive Therapy, Borowska 213, 50-529 Wroclaw, Poland
Country [1] 308045 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307475 0
Bioethics Committee of the Wroclaw Medical University, Poland
Ethics committee address [1] 307475 0
Ethics committee country [1] 307475 0
Poland
Date submitted for ethics approval [1] 307475 0
30/10/2020
Approval date [1] 307475 0
26/11/2020
Ethics approval number [1] 307475 0
KB–751/2020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107362 0
Mr Michal Pilarski, MD
Address 107362 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 107362 0
Poland
Phone 107362 0
+48 71 712 89 39
Fax 107362 0
Email 107362 0
[email protected]
Contact person for public queries
Name 107363 0
Patrycja Lesnik, MD, PhD
Address 107363 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 107363 0
Poland
Phone 107363 0
+48 71 712 89 39
Fax 107363 0
Email 107363 0
[email protected]
Contact person for scientific queries
Name 107364 0
Patrycja Lesnik, MD, PhD
Address 107364 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 107364 0
Poland
Phone 107364 0
+48 71 712 89 39
Fax 107364 0
Email 107364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Available for 5 years after publication on reasonable request.
Available to whom?
Only to researchers who provide a methodologically relevant explanation.
Available for what types of analyses?
Only to achieve the purposes of the approved request.
How or where can data be obtained?
The data can be obtained by emailing the principal investigator ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10012Ethical approval    381076-(Uploaded-08-12-2020-21-54-07)-Study-related document.pdf



Results publications and other study-related documents

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