Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000161820
Ethics application status
Approved
Date submitted
15/02/2020
Date registered
16/02/2021
Date last updated
16/02/2021
Date data sharing statement initially provided
16/02/2021
Date results information initially provided
16/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Erector Spinae Plane Block Versus Mid-point Transverse Process to Pleura Block for post-Thoracotomy pain
Scientific title
Erector Spinae Plane Block Versus Mid-point Transverse Process to Pleura Block for Thoracotomy
Secondary ID [1] 300552 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Post-thoracotomy pain 316276 0
Condition category
Condition code
Anaesthesiology 314554 314554 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Erector Spinae Plane Block (ESPB) ;
The blocks will performed by same anaesthesiologist, before extubation. Linear USG probe will use to display erector spinae muscles and T4 transverse proces approximately 3-4 cm lateral from the midline. A 22-gauge, 80-mm block needle will advance (in plane) in cranio-caudal direction until touch the T4 transverse process under the erector spinae muscle.
Bilevel ESP blocks will perform at T4 and T6 levels with 30 ml 0,375 % bupivacaine (15 ml for each level.
Intervention code [1] 316853 0
Treatment: Other
Comparator / control treatment
Mid-point transverse process to pleura (MTP) block ;
The blocks will perform by same anaesthesiologist immediately before extubation. After identification of the mid point between the transverse process and pleura using parasagittal scan, the needle will advance in-plane from the caudal to cranial direction. Bilevel MTP blocks will perform at T4 and T6 levels with 30 ml 0,375 % bupivacaine (15 ml for each level)
Control group
Active

Outcomes
Primary outcome [1] 322875 0
Total opioid consumption with patient controlled analgesia (PCA) ratio of demands to deliveries in the first 24 hours from data-linkage to medical records.
Timepoint [1] 322875 0
First 24 hours
Secondary outcome [1] 380110 0
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain).
Timepoint [1] 380110 0
Pain scores were assessed at postoperative 1, 2, 4, 6,12,24 hours.

Eligibility
Key inclusion criteria
American Society of Anesthesiologist's physiologic state I-III patients undergoing thoracotomy surgery
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Emergent surgery
• Age <18 years or> 65 years
• Non cooperative patients
• Patients with allergies to one of the drugs used in the study.
• Patients with chronic pain, bleeding disorders, renal or hepatic insufficiency,
• Patients with diabetic neuropathy
• Patients with severe hepatic or renal insufficiency

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)
randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software
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

Sample size is calculate using previous studies about thoracotomy pain. VAS score as the main parameter (mean standard deviation 1.5-2.0 cm) considering 5% margin of error and 90% power and considering a difference of 2cm as clinically significant. The total sample size was calculated as 60.
The clinical data will collect, verify (mean, median, standard deviation) then analyse using paired and unpaired T-test, Chi-square test, Mann Whitney U-test, Wilcoxon rank sum test, p-value (significant < 0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/11/2019
Date of last participant enrolment
Anticipated
Actual
31/12/2020
Date of last data collection
Anticipated
Actual
14/01/2021
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 22356 0
Turkey
State/province [1] 22356 0
konya

Funding & Sponsors
Funding source category [1] 304963 0
University
Name [1] 304963 0
Necmettin Erbakan University Meram Mediacal Faculty
Country [1] 304963 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University Meram Mediacal Faculty
Address
Necmettin Erbakan University
 MeramSchool of Medicine 
Department ofAnesthesiology and Reanimation
42080, Meram, Konya,TURKEY 
Country
Turkey
Secondary sponsor category [1] 305322 0
None
Name [1] 305322 0
Address [1] 305322 0
Country [1] 305322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305373 0
Necmettin Erbakan University, Meram School of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 305373 0
Necmettin Erbakan University , 
Meram School of Medicine
 Department of Anesthesiology and Reanimation
42080, Meram, Konya,TURKEY 
Ethics committee country [1] 305373 0
Turkey
Date submitted for ethics approval [1] 305373 0
15/05/2019
Approval date [1] 305373 0
29/05/2019
Ethics approval number [1] 305373 0
2019/217
Ethics committee name [2] 305382 0
Republic of Turkey Ministry of Health
Ethics committee address [2] 305382 0
Republic of Turkey Ministry of Health
Dumlupinar street postcode : 06800
Çankaya/Ankara /Turkey
Ethics committee country [2] 305382 0
Turkey
Date submitted for ethics approval [2] 305382 0
26/07/2019
Approval date [2] 305382 0
27/09/2019
Ethics approval number [2] 305382 0
19-AKD-107

Summary
Brief summary
Thoracotomy surgery is one of the most painful surgical procedures followed by intense, acute and chronic pain. The thoracic paravertebral block (PVB) is known to be the gold standard for acute post-thoracotomy analgesia for a long time . In recent years, many novel posterior thoracic wall blocks have been described as alternatives for PVB in order to avoid possible nerve-vessel damages and pneumothorax such as Erector Spinae Plane Block (ESPB) and mid-point transverse process to pleura (MTP) block .To date, there are no studies that compare the efficacy of ESP block and MTP block. The objective of this randomized study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100158 0
Prof ALPER KILICASLAN
Address 100158 0
Necmettin Erbakan University,
 Meram School of Medicine Department of Anesthesiology and Reanimation
42080, Meram, Konya,TURKEY 
Country 100158 0
Turkey
Phone 100158 0
+90 332 414 35 88
Fax 100158 0
Email 100158 0
[email protected]
Contact person for public queries
Name 100159 0
Prof Alper KILICASLAN
Address 100159 0
Necmettin Erbakan University,
 Meram School of Medicine Department of Anesthesiology and Reanimation
42080, Meram, Konya,TURKEY 
Country 100159 0
Turkey
Phone 100159 0
+90 332 414 35 88
Fax 100159 0
Email 100159 0
[email protected]
Contact person for scientific queries
Name 100160 0
Prof ALPER KILICASLAN
Address 100160 0
Necmettin Erbakan University,
 Meram School of Medicine Department of Anesthesiology and Reanimation
42080, Meram, Konya,TURKEY 
Country 100160 0
Turkey
Phone 100160 0
+90 332 414 35 88
Fax 100160 0
Email 100160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6924Otherdata collection document   data collection document 379275-(Uploaded-15-02-2020-03-38-42)-Study-related document.docx
6925Ethical approval    379275-(Uploaded-15-02-2020-03-41-18)-Study-related document.docx
6926Informed consent form    379275-(Uploaded-25-03-2020-03-34-24)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.