Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001093572
Ethics application status
Approved
Date submitted
30/05/2024
Date registered
11/09/2024
Date last updated
11/09/2024
Date data sharing statement initially provided
11/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postoperative Effect of Trunchal Plan Blocks in Thoracic Surgery Operations
Scientific title
Comparison of the Analgesic Effects of the Erector Spinae Plan Block and Thoracic Paravertebral Block in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Secondary ID [1] 312238 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Video-assisted thoracoscopic surgery
 333944 0
Other anaesthesiology 333945 0
Condition category
Condition code
Anaesthesiology 330619 330619 0 0
Pain management
Surgery 330940 330940 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thoracic Paravertebral Block: Thoracic paravertebral block(TPVB) is the technique of injecting local anesthetic along side the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen. (https://www.nysora.com/regional-anesthesia-for-specific-surgical-procedures/abdomen/thoracic-lumbar-paravertebral-block/) After the most prominent C7, processus spinosus in the cervical region was determined by palpation with the patients in a sitting position with their head slightly tilted forward, the relevant area was cleaned, we marked caudally one by one under US guidance. And 2,5-3 cm lateral of the T4 spinous process was marked as the injection point. At the needle insertion site, 2 mL of 2% lidocaine was infiltrated into the subcutaneous tissue.
After placing the linear US probe on the marked area for paravertebral block application in the longitudinal plane, consecutive transverse processes and the pleura, superior costotransverse ligament, and paravertebral area were determined. With the in-plane technique, an 80 mm 22 gauge peripheral block needle was directed caudally to the cephalad, and the needle tip was advanced into the thoracic paravertebral area until the superior costotransverse ligament was passed. After confirming there was no vascular interference with aspiration, 2-3 mL of 0,9% saline was administered and ventral movement of the parietal pleura was observed to confirm the needle location, and TPVB was administered by injecting 20 mL of 0.25% bupivacaine.
All TPVBs were performed by an anesthesiologist who has been working for at least 5 years.
The approximate time taken to perform the thoracic paravertebral block is 10 min and performed 10 minutes before commencing surgery. The suitability of the block was evaluated with the loss of cold sensation up and down two levels in the mid-clavicular line.
Intervention code [1] 328689 0
Prevention
Intervention code [2] 328955 0
Treatment: Surgery
Comparator / control treatment
Erector Spinae Plane Block: Erector spinae plane block (ESPB) is an interfascial plane block first described in 2016 by Forero et al as an effective treatment method for the treatment of thoracic neuropathic pain. Trapezius, rhomboid, and erector spina muscles and consecutive transverse processes were determined with a linear ultrasound (US) probe placed in the longitudinal plane to the area marked. With the in-plane technique, an 80 mm 22 gauge peripheral block needle was directed caudally to the cephalad, and we advanced the needle tip between the anterior fascia of the erector spina muscle group and the T4 vertebral transverse process. After confirming that there was no vascular intervention by aspiration, 2-3 mL of 0.9% saline was administered and simultaneous monitoring of hydro dissection and distribution confirmed the needle location via ultrasonography(USG), ESPB was administered by injecting 20 mL of 0.25% bupivacaine.
All ESPBs were performed by an anesthesiologist who has been working for at least 5 years. The approximate time taken to perform the thoracic paravertebral block is 10 min and performed 10 minutes before commencing surgery. The suitability of the block was evaluated with the loss of cold sensation up and down two levels in the mid-clavicular line.
Control group
Active

Outcomes
Primary outcome [1] 338376 0
The primary outcome measure of the study was to assess total analgesic drug consumption at the end of the 24 hours assessed using patient medical records.
Timepoint [1] 338376 0
postoperative 24th hour
Secondary outcome [1] 435678 0
Postoperative complications(hypotension, bradicardy, pnoemothorax, etc) assessed using patient medical records
Timepoint [1] 435678 0
postoperative 24th hour
Secondary outcome [2] 435679 0
block application time
Timepoint [2] 435679 0
postoperative 24th hour
Secondary outcome [3] 435680 0
Respiratory functions
Timepoint [3] 435680 0
postoperative 24th hour

Eligibility
Key inclusion criteria
Patients aged between 18 and 70 years, with the American Society of Anesthesiologists' physical status classification score (ASA) II-III, without mental or psychiatric defect, who were scheduled for elective video-assisted thoracoscopic surgery between March 2021 and July 2021 are included in the study.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients outside the age range of 18-70 years, with ASA score above III, patients with local/systemic infection, severe arrhythmia, cardiac, hepatic and renal failure are not included in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Continuous variables will be presented as mean (±SD) or median (Minimum-Maximum or IQR), depending on whether the data are normally distributed. Data distribution will be evaluated using the Kolmogorov-Smirnov test or the Shapiro-Wilk test. Categorical variables such as gender and type of operation will be analyzed using the ?2 test. Data with normal distribution will be analyzed using Student's T test, and data with non-normal distribution will be analyzed using the Mann-Whitney U test. p< 0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2021
Date of last participant enrolment
Anticipated
Actual
1/07/2021
Date of last data collection
Anticipated
Actual
2/07/2021
Sample size
Target
54
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 26355 0
Turkey
State/province [1] 26355 0

Funding & Sponsors
Funding source category [1] 316868 0
Self funded/Unfunded
Name [1] 316868 0
Country [1] 316868 0
Primary sponsor type
University
Name
Afyonkarahisar Health Science University
Address
Country
Turkey
Secondary sponsor category [1] 318802 0
None
Name [1] 318802 0
Address [1] 318802 0
Country [1] 318802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315401 0
Afyonkarahisar Health Science University Ethics Committee
Ethics committee address [1] 315401 0
Ethics committee country [1] 315401 0
Turkey
Date submitted for ethics approval [1] 315401 0
03/12/2020
Approval date [1] 315401 0
04/12/2020
Ethics approval number [1] 315401 0
562

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

Contacts
Principal investigator
Name 134586 0
A/Prof Bilal Atilla Bezen
Address 134586 0
Afyonkarahisar Saglik Bilimleri Üniversitesi Hastanesi Ali Çetinkaya Kampusü Dörtyol mah. 2078 sok. No. 3/4 AFYONKARAHISAR
Country 134586 0
Turkey
Phone 134586 0
+905419671370
Fax 134586 0
Email 134586 0
[email protected]
Contact person for public queries
Name 134587 0
Bilal Atilla Bezen
Address 134587 0
Afyonkarahisar Saglik Bilimleri Üniversitesi Hastanesi Ali Çetinkaya Kampusü Dörtyol mah. 2078 sok. No. 3/4 AFYONKARAHISAR
Country 134587 0
Turkey
Phone 134587 0
+905419671370
Fax 134587 0
Email 134587 0
[email protected]
Contact person for scientific queries
Name 134588 0
Bilal Atilla Bezen
Address 134588 0
Afyonkarahisar Saglik Bilimleri Üniversitesi Hastanesi Ali Çetinkaya Kampusü Dörtyol mah. 2078 sok. No. 3/4 AFYONKARAHISAR
Country 134588 0
Turkey
Phone 134588 0
+905419671370
Fax 134588 0
Email 134588 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
No consent was obtained for the sharing of individual participant data.


What supporting documents are/will be available?

No Supporting Document Provided



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.