Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000750684
Ethics application status
Approved
Date submitted
7/05/2023
Date registered
11/07/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
11/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the efficacy of modified thoracolumbar interfacial plane block (mTLIP) and erector spinae plane block (ESP) for preemptive analgesia in lumbar discectomy surgery
Scientific title
Comparison of the effects of modified thoracolumbar interfacial plane (mTLIP) block and erector spina plane block on postoperative pain and opioid analgesic consumption in patients undergoing lumbar discectomy for lumbar disc herniation
Secondary ID [1] 309618 0



None
Universal Trial Number (UTN)
U1111-1292-2516
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lumbar disc herniation 329936 0
Condition category
Condition code
Neurological 326842 326842 0 0
Neurodegenerative diseases
Anaesthesiology 327011 327011 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.


- 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
- to be administered only approximately 20-30 minutes before the onset of anaesthesia.
- only once in the preoperative block room approximately 20-30 minutes before induction of anaesthesia
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.
- plane blocks will be applied under ultrasound guidance.
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- Postoperative evaluations of patients will be performed face to face.
Patients will be routinely administered 1 g paracetamol intravenously at 8 hour intervals in the postoperative period. 100 mg tramadol intravenously will be administered if their pain is above VAS 4 despite this.
- This study was followed up in the neurosurgery unit of SBU Gazi Yasargil Training and Research Hospital.
- Patients were sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied.
Patients will be monitored for pain and side effects at the neurosurgery unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
- Both plan blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.
Intervention code [1] 326040 0
Prevention
Intervention code [2] 326041 0
Treatment: Other
Comparator / control treatment

Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.

- 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
- to be administered only approximately 20-30 minutes before the onset of anaesthesia.
- only once in the preoperative block room approximately 20-30 minutes before induction of anaesthesia
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.
- plane blocks will be applied under ultrasound guidance.
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- Postoperative evaluations of patients will be performed face to face.
Control group
Active

Outcomes
Primary outcome [1] 334688 0

Low back pain and leg pain as an extension of the travelling nerve assessed using visual pain scores (VAS)
Timepoint [1] 334688 0
- Primer outcomes assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours
- The assessment will be done face-to-face and recorded on medical follow-up forms.
- Data will be obtained from these medical follow-up forms.
Primary outcome [2] 334689 0
Assessment of the patient's agitation on awakening from anaesthesia using the Ricker Sedation-Agitation Scale (RSAS)
Timepoint [2] 334689 0
- When the patient wakes up from anaesthesia
- The evaluation will be done and recorded by the anesthesiologist following the surgery.
- Data will be obtained from these medical follow-up forms.
Secondary outcome [1] 421669 0

- Postoperative nausea and vomiting will be assessed as a composite outcome by assessment of patient and nurse follow-up forms

- Postoperative nausea and vomiting will be queried as a composite outcome
Timepoint [1] 421669 0
postoperative 1st, 2nd, 4th, 8th and 24th hours
Secondary outcome [2] 421670 0

The severity of pain will be assessed according to Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS)
Timepoint [2] 421670 0
postoperative 1st, 2nd, 4th, 8th and 24th hours
Secondary outcome [3] 421671 0
systolic, diastolic and mean arterial pressure monitoring during surgery

Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.
Timepoint [3] 421671 0
before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
Secondary outcome [4] 421672 0
heart rate monitoring during surgery

the measurement will be obtained by electrocardiographic monitoring
Timepoint [4] 421672 0
before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
Secondary outcome [5] 421673 0
systolic, diastolic and mean arterial pressure monitoring

Blood pressure will be measured with a non-invasive automatic pneumatic cuff
Timepoint [5] 421673 0


postoperative 1st, 2nd, 4th, 8th and 24th hours
Secondary outcome [6] 421674 0
heart rate

heart rate will be measured by pulse oximetry
Timepoint [6] 421674 0
postoperative 1st, 2nd, 4th, 8th and 24th hours
Secondary outcome [7] 421675 0
duration of surgery

will be obtained from anaesthesia follow-up forms
Timepoint [7] 421675 0
during surgery
Secondary outcome [8] 421676 0
duration of anaesthesia

will be obtained from anaesthesia follow-up forms
Timepoint [8] 421676 0
during anaesthesia

the time from the start of the patient's induction of anaesthesia to the time of discharge to the postanesthesia care unit (PACU) at the end of surgery
Secondary outcome [9] 423977 0
- Amount of additional postoperative opioid analgesic requirement

-Primer outcomes assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours
Timepoint [9] 423977 0
- Assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours
- Information on the amount of postoperative additional opioid analgesic requirement will be obtained from the patient's anesthesia follow-up forms, the post-operative neurosurgery nurse follow-up forms and hospital records.
Secondary outcome [10] 423978 0
- Amount of opioids consumed during surgery
Timepoint [10] 423978 0
- The evaluation will be assessed at the end of anesthesia
-Information on the amount of postoperative additional opioid analgesic requirement will be obtained from the patient's anesthesia follow-up forms, and hospital records.

Eligibility
Key inclusion criteria
Patients between 18-70 years of age, ASA I-III, scheduled for Lumbar Disc Herniation operation under general anaesthesia.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA >III
body mass index (BMI) > 35 kg/m2
known allergy to local anaesthetics
presence of preoperative chronic pain
presence of coagulopathy
those who are unable to give written consent
non-voluntary patients

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 phone/fax/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 (i.e. computerised 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
G-Power version 3.1.9.4 (Universität Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1,12. The minimum number of patients to be included in the study was calculated as 42.
SPSS 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student’s t-test. Mann– Whitney U tests were used to compare the data differ from the normal distribution. p <0.05 was considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
38
Final
Recruitment outside Australia
Country [1] 25435 0
Turkey
State/province [1] 25435 0
Diyarbakir

Funding & Sponsors
Funding source category [1] 313797 0
Hospital
Name [1] 313797 0
TR HSU Diyarbakir Gazi Yasargil TRH
Country [1] 313797 0
Turkey
Primary sponsor type
University
Name
Health Sciences University Training and Research Hospital
Address
Mekteb-i Tibbiye-i Sahane (Hamidiye) Külliyesi
Selimiye Mah. Tibbiye Cad. No:38 34668 Üsküdar, Istanbul
Country
Turkey
Secondary sponsor category [1] 315629 0
Individual
Name [1] 315629 0
Fatma Acil
Address [1] 315629 0

TR HSU Diyarbakir Gazi Yasargil TRH. Address of the institute : Elazig Yolu 10. Km Üçkuyular Mevkii , zip code 21070, Kayapinar/Diyarbakir
Country [1] 315629 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312964 0
TR HSU Diyarbakir Gazi Yasargil TRH Ethic Committee
Ethics committee address [1] 312964 0
Ethics committee country [1] 312964 0
Turkey
Date submitted for ethics approval [1] 312964 0
30/09/2022
Approval date [1] 312964 0
05/05/2023
Ethics approval number [1] 312964 0
373

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

Contacts
Principal investigator
Name 126506 0
Dr Fatma Acil
Address 126506 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute: Elazig Yolu 10. Km Üçkuyular Mevkii zip code:21070,Kayapinar/Diyarbakir
Country 126506 0
Turkey
Phone 126506 0
+90 533 722 5225
Fax 126506 0
Email 126506 0
[email protected]
Contact person for public queries
Name 126507 0
Cem Kacar
Address 126507 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute: Elazig Yolu 10. Km Üçkuyular Mevkii zip code:21070,Kayapinar/Diyarbakir
Country 126507 0
Turkey
Phone 126507 0
+90 412 251 91 29
Fax 126507 0
Email 126507 0
[email protected]
Contact person for scientific queries
Name 126508 0
Fatma Acil
Address 126508 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute: Elazig Yolu 10. Km Üçkuyular Mevkii zip code:21070,Kayapinar/Diyarbakir
Country 126508 0
Turkey
Phone 126508 0
+90 533 722 5225
Fax 126508 0
Email 126508 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?
after de-identification; all individual participant data collected during the research and the primary and secondary outcomes of the study
When will data be available (start and end dates)?
data can be shared immediately after publication, no end date set.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (e-mail: [email protected])


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.