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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
Date results information 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
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Scientific title
Postoperative Effects of Erector Spinae Plane Block in Patients Operated with Lumbotomy Surgical Incision:
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Secondary ID [1]
310550
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney stone
333448
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Kidney tumor
333449
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Kidney patologies requiring unilateral surgery
333451
0
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Acute kidney disease
333452
0
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Chronic kidney disease
333453
0
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Condition category
Condition code
Anaesthesiology
328125
328125
0
0
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Pain management
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Anaesthesiology
328126
328126
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0
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Anaesthetics
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Renal and Urogenital
328127
328127
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0
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Kidney disease
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Renal and Urogenital
330122
330122
0
0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326945
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
336002
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Intraoperative remifentanyl consumption determined from device records
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Assessment method [1]
336002
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Timepoint [1]
336002
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Assessed by treating anesthesiologist 5 minutes after operation (Primary timepoint)
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Primary outcome [2]
336003
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Postoperative morphine consumption was obtained from the records of the infusion device we used to provide patient-controlled analgesia.
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Assessment method [2]
336003
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Timepoint [2]
336003
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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
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Secondary outcome [1]
426452
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Postoperative pain levels of our patients with the numerical rating scale (NRS)
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Assessment method [1]
426452
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Timepoint [1]
426452
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Postoperative at the 0th, 1st, 2nd, 3rd, 4th, 6th, 8th, 12th,(Primary timepoint) 16th, 20th, 24th, 32nd, 40th, 48th hours
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/01/2019
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Date of last participant enrolment
Anticipated
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Actual
1/01/2020
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Date of last data collection
Anticipated
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Actual
2/01/2020
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
25755
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Turkey
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State/province [1]
25755
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Hatay
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Funding & Sponsors
Funding source category [1]
314753
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University
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Name [1]
314753
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Mustafa Kemal University
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Address [1]
314753
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Mustafa Kemal Üniversitesi Tip Fakültesi,Tayfur Sökmen Campus (31060) Alahan-Antakya/Hatay,Türkiye
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Country [1]
314753
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Turkey
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Primary sponsor type
Hospital
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Name
Mustaf Kemal University Research Hospital
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Address
Mustaf Kemal University Research Hospital, Alahan, 31001 Antakya/Hatay, Türkiye
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Country
Turkey
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Secondary sponsor category [1]
317594
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None
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Name [1]
317594
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Address [1]
317594
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Country [1]
317594
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313761
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Hatay Mustafa Kemal Üniversity Faculty of Medicine Clinical Research Ethics Committee
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Ethics committee address [1]
313761
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Mustafa Kemal University, Alahan, 31001 Antakya/Hatay, Türkiye
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Ethics committee country [1]
313761
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Turkey
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Date submitted for ethics approval [1]
313761
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01/10/2018
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Approval date [1]
313761
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01/12/2018
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Ethics approval number [1]
313761
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
129278
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A/Prof Sedat Hakimoglu
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Address
129278
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Mustafa Kemal Üniversitesi Faculty of Medicine, Alahan, 31001 Antakya/Hatay, Türkiye
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Country
129278
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Turkey
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Phone
129278
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+905058610750
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Fax
129278
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Email
129278
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[email protected]
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Contact person for public queries
Name
129279
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A/Prof Sedat Hakimoglu
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Address
129279
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Mustafa Kemal Üniversitesi Faculty of Medicine, Alahan, 31001 Antakya/Hatay, Türkiye
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Country
129279
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Turkey
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Phone
129279
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+905058610750
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Fax
129279
0
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Email
129279
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[email protected]
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Contact person for scientific queries
Name
129280
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A/Prof Sedat Hakimoglu
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Address
129280
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Mustafa Kemal Üniversitesi Faculty of Medicine, Alahan, 31001 Antakya/Hatay, Türkiye
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Country
129280
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Turkey
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Phone
129280
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+905058610750
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Fax
129280
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Email
129280
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20250
Statistical analysis plan
[email protected]
386555-(Uploaded-06-09-2023-10-28-43)-Study-related document.docx
20252
Study protocol
386555-(Uploaded-06-09-2023-10-32-26)-Study-related document.docx
20255
Ethical approval
ethics committee decision date 28/06/2018
386555-(Uploaded-02-01-2024-17-49-13)-Study-related document.pdf
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.
Download to PDF