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Trial registered on ANZCTR


Registration number
ACTRN12624000415505
Ethics application status
Approved
Date submitted
6/09/2023
Date registered
4/04/2024
Date last updated
4/04/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the Postoperative Effects of the Erector Spinae Plane Block and Local Infiltration Analgesia in Patients Operated with Lumbotomy Surgery Incision: Randomized Clinical Study
Scientific title
Postoperative Effects of Erector Spinae Plane Block in Patients Operated with Lumbotomy Surgical Incision:
Secondary ID [1] 310550 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney stone 333448 0
Kidney tumor 333449 0
Kidney patologies requiring unilateral surgery 333451 0
Acute kidney disease 333452 0
Chronic kidney disease 333453 0
Condition category
Condition code
Anaesthesiology 328125 328125 0 0
Pain management
Anaesthesiology 328126 328126 0 0
Anaesthetics
Renal and Urogenital 328127 328127 0 0
Kidney disease
Renal and Urogenital 330122 330122 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The erector spinae plane (ESP) block is a paraspinal fascial plane block.. Local anesthetic drug administration between the tip of the transverse process of vertebra and the anterior fascia of the erector spinae muscles in ESP block . This block is applied under ultrasound guidance. In ESP block, a linear 38-mm, high frequency 10-15 MHz transducer linear usg probe was placed to the 2-3 cm lateral of the T9 vertebral spinous process on the paramedian sagittal plane. The transverse process of the vertebra, trapezius muscle, erector spinae muscle, and subcutaneous tissue were visualized. The plane between the anterior fascia of the erector spina muscle and the T9 vertebra transverse process was aimed from the side to be operated with the lumbotomy incision, with a 22 G 80 mm stimuplex needle, using the in-plane technique. The targeted point was reached by advancing the needle in the caudal and cephalic directions at 45° angles. 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine local anesthetic were administered in a controlled manner, carrying out negative aspiration at each 5 mL. The procedure was terminated observing the detached fascial plane after the administration of the local anesthetic solition, Before this block, the anesthetist will review the clinical records again and vital parameters will be closely monitored throughout the procedure. This block will be applied by an experienced anesthesiologist while the patients are under anesthesia and will not be repeated.
Intervention code [1] 326945 0
Prevention
Comparator / control treatment
Our first aim in this study was to observe and compare the effects of Local infiltration analgesia (LIA) and ESP block methods. LIA,(5 ml 0.5% mg bupivacaine,+ 5 ml 2% lidocaine) 10 mL of local anesthetic was administered to the skin, superficial subcutaneous and deep tissue along the incision line before the surgical incision.
LIA the anesthetist will review the clinical records again and vital parameters will be closely monitored throughout the procedure.
LIA will be applied by an experienced anesthesiologist and completed 10 minutes before the surgical incision begins while the patient is under general anesthesia and will not be repeated.
Control group
Active

Outcomes
Primary outcome [1] 336002 0
Intraoperative remifentanyl consumption determined from device records
Timepoint [1] 336002 0
Assessed by treating anesthesiologist 5 minutes after operation (Primary timepoint)
Primary outcome [2] 336003 0
Postoperative morphine consumption was obtained from the records of the infusion device we used to provide patient-controlled analgesia.
Timepoint [2] 336003 0
Total morphine and paracetamol doses consumed by the postoperative patients at the 0th, 1st, 2nd, 3rd, 4th, 6th, 8th, 12th (Primary timepoint), 16th, 20th, 24th, 32nd, 40th, 48th hours
Secondary outcome [1] 426452 0
Postoperative pain levels of our patients with the numerical rating scale (NRS)
Timepoint [1] 426452 0
Postoperative at the 0th, 1st, 2nd, 3rd, 4th, 6th, 8th, 12th,(Primary timepoint) 16th, 20th, 24th, 32nd, 40th, 48th hours

Eligibility
Key inclusion criteria
Patients in the ASA I-III risk group,
Aged 18-75,
Body mass index less than 35 kg/m² (BMI < 35 kg/m²),
Operated with open, unilateral, lumbotomy surgical incision were included
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to the drugs used in our study,
Having active infection in the procedure area,
Mental defect, major vertebral anomalies,
Known blood and coagulation diseases,
Using anticoagulant drugs
Those who received medical treatment that could lead to opioid tolerance

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)
Central 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2019
Date of last participant enrolment
Anticipated
Actual
1/01/2020
Date of last data collection
Anticipated
Actual
2/01/2020
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 25755 0
Turkey
State/province [1] 25755 0
Hatay

Funding & Sponsors
Funding source category [1] 314753 0
University
Name [1] 314753 0
Mustafa Kemal University
Country [1] 314753 0
Turkey
Primary sponsor type
Hospital
Name
Mustaf Kemal University Research Hospital
Address
Mustaf Kemal University Research Hospital, Alahan, 31001 Antakya/Hatay, Türkiye
Country
Turkey
Secondary sponsor category [1] 317594 0
None
Name [1] 317594 0
Address [1] 317594 0
Country [1] 317594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313761 0
Hatay Mustafa Kemal Üniversity Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 313761 0
Mustafa Kemal University, Alahan, 31001 Antakya/Hatay, Türkiye
Ethics committee country [1] 313761 0
Turkey
Date submitted for ethics approval [1] 313761 0
01/10/2018
Approval date [1] 313761 0
01/12/2018
Ethics approval number [1] 313761 0

Summary
Brief summary
Our study aim was to observe the effects of interfacial block method. Additionaly our study showed on the intraoperative and postoperative opioid consumption of our patients . Also we secondary measured the postoperative pain levels of our patients with the numerical rating scale (NRS)
it has been shown that the intraoperative LIA method is more effective in terms of opioid consumption, in controlling the pain intraoperation performed but the ESP block method provides longer and more effective pain control in postoperative follow-ups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129278 0
A/Prof Sedat Hakimoglu
Address 129278 0
Mustafa Kemal Üniversitesi Faculty of Medicine, Alahan, 31001 Antakya/Hatay, Türkiye
Country 129278 0
Turkey
Phone 129278 0
+905058610750
Fax 129278 0
Email 129278 0
[email protected]
Contact person for public queries
Name 129279 0
Sedat Hakimoglu
Address 129279 0
Mustafa Kemal Üniversitesi Faculty of Medicine, Alahan, 31001 Antakya/Hatay, Türkiye
Country 129279 0
Turkey
Phone 129279 0
+905058610750
Fax 129279 0
Email 129279 0
[email protected]
Contact person for scientific queries
Name 129280 0
Sedat Hakimoglu
Address 129280 0
Mustafa Kemal Üniversitesi Faculty of Medicine, Alahan, 31001 Antakya/Hatay, Türkiye
Country 129280 0
Turkey
Phone 129280 0
+905058610750
Fax 129280 0
Email 129280 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?




Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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