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Trial registered on ANZCTR


Registration number
ACTRN12623000772640p
Ethics application status
Submitted, not yet approved
Date submitted
12/05/2023
Date registered
17/07/2023
Date last updated
17/07/2023
Date data sharing statement initially provided
17/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of quadratus lumborum block (QLB) applied for preemptive analgesia in donors and recipients in kidney transplantation operations with intravenous pain medication (IVA) group
Scientific title
Comparison of the effects of quadratus lumborum block (QLB) applied for preemptive analgesia on post-operative pain in recipients and donors in renal transplantation surgery with intravenous analgesic (IVA) group
Secondary ID [1] 309647 0
none
Universal Trial Number (UTN)
U1111-1292-5270
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney transplant 329981 0
Condition category
Condition code
Anaesthesiology 326888 326888 0 0
Pain management
Renal and Urogenital 327137 327137 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Under general anaesthesia, quadratus lumborum block with 20 ml of 0.25% bupivacaine will be applied to the side where the surgical incision will be made under ultrasound guidance to the recipient and donor patients included in the kidney transplant surgery programme under elective conditions.

- plane block ultrasound-guided intra-abdominal injection into the appropriate anatomical area
- the injection will be administered immediately after general anaesthesia and intubation of the patient
- to monitor compliance with the intervention The medical files and laboratory blood tests of the patients will be examined to determine whether there are any contraindications to the intervention (patients will be excluded in case of bleeding diathesis such as intra-abdominal fluid accumulation, cystic formation, INR > 2 or thrombocytopenia).
Blood pressure and heart rate values of the patient and the amount of fentanyl consumed will be recorded throughout the surgery.
The level of sedation-agitation will be evaluated during extubation at the end of surgery.
In the postoperative period, blood pressure, heart rate, pain scoring and the amount of opioid analgesic consumed will be recorded by the anaesthesiologist in the general surgery organ transplant unit and the general surgery specialist and nurses in the organ transplant service at the 1st, 2nd, 6th, 12th, and 24th hours.
The patient's satisfaction level will be evaluated and recorded 24 hours after the operation.
Intervention code [1] 326088 0
Prevention
Intervention code [2] 326089 0
Treatment: Surgery
Comparator / control treatment
-This group will be administered 100 mg paracetamol + 100 mg tramadol intravenously 20 min before the end of surgery without plane block.
-The sedation-agitation level of the patient after extubation will be evaluated by the anaesthesiologist.
- Operation and ward follow-up forms will be used to monitor compliance with comparison treatment
-In the postoperative period, pain levels, blood pressure, heart rate, amount of opioid analgesic consumed and side effects will be recorded at the 1st, 2nd, 6th, 12th, 24th hours by the anaesthesiologist and the nurse and general surgeon working in the general surgery organ transplant unit.
-Satisfaction assessment will be made at the end of 24 hours postoperatively.
Control group
Active

Outcomes
Primary outcome [1] 334741 0
assessment of pain (NRS) level at 1st, 2nd, 6th, 12th, 24th postoperative hours
Timepoint [1] 334741 0
postoperative 1st, 2nd, 6th, 12th, 24th hours
Primary outcome [2] 334742 0
total postoperative tramadol consumption
these data will be collected from review of medical records
Timepoint [2] 334742 0
within 24 hours postoperatively
Secondary outcome [1] 421917 0
sedation- agitation level after extubation
these data will be collected from review of medical records
Timepoint [1] 421917 0
after extubation
Secondary outcome [2] 421918 0
measurement of blood pressure at 1st, 2nd, 6th, 12th, 24th postoperative hours
these data will be collected from review of medical records
Timepoint [2] 421918 0
at 1st, 2nd, 6th, 12th, 24th postoperative hours
Secondary outcome [3] 421919 0
measurement of heart rate at 1st, 2nd, 6th, 12th, 24th postoperative hours
these data will be collected from review of medical records
Timepoint [3] 421919 0
at 1st, 2nd, 6th, 12th, 24th postoperative hours
Secondary outcome [4] 421920 0
patient satisfaction assessment
Patient satisfaction score:
Patients' satisfaction with the quality of pain management will be assessed at 24 hours postoperatively using the following scale:
1 = very dissatisfied; 2 = quite dissatisfied; 3 = moderate; 4 = quite satisfied; 5 = very satisfied.
Timepoint [4] 421920 0
at the end of 24 hours postoperatively
Secondary outcome [5] 421921 0
blood pressure measurement every 15 minutes during surgery
these data will be collected from review of medical records
Timepoint [5] 421921 0
during surgery
Secondary outcome [6] 421922 0
heart rate measurement every 15 minutes during surgery
these data will be collected from the review of medical records such as anaesthesia follow-up forms
Timepoint [6] 421922 0
during surgery
Secondary outcome [7] 421923 0
amount of fentanyl consumed during the operation
these data will be collected from review of medical records
Timepoint [7] 421923 0
during surgery
Secondary outcome [8] 422699 0
nausea-vomiting
Timepoint [8] 422699 0
Will be followed from the postoperative period until discharge
Data evaluation will be obtained from service follow-up forms.
Secondary outcome [9] 422700 0
Shoulder pain
Timepoint [9] 422700 0
Will be followed from the postoperative period until discharge
Data evaluation will be obtained from service follow-up forms.
The patient is asked to answer whether the pain is present or absent
Secondary outcome [10] 422701 0
Respiratory distress
Timepoint [10] 422701 0
Will be followed from the postoperative period until discharge
Data evaluation will be obtained from service follow-up forms.
The patient is asked to answer whether the pain is present or absent
Secondary outcome [11] 422702 0
Length of hospital stay
Timepoint [11] 422702 0
These data will be collected from review of medical records
Data will be obtained at discharge from hospital

Eligibility
Key inclusion criteria
Patients aged 18-70 years,
ASA I-III,
being a volunteer kidney recipient or volunteer donor in a kidney transplant programme under general anaesthesia
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age <18 years or > 70 years
ASA >III
body mass index (BMI) > 35 kg/m2
known allergy to local anaesthetics or parasetamol/tramadol
presence of preoperative chronic pain
ppresence of accumulated fluid or cystic formation in the abdomenresence of coagulopathy

those who are unable to give written consent

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)
Sealed opaque envelopes
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/N=1. A total minimum of 84 patients will be included in the study, including 21 patients in each subgroup of the recipient and donor groups with and without block treatment.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
27/07/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 25502 0
Turkey
State/province [1] 25502 0
Diyarbakir

Funding & Sponsors
Funding source category [1] 313831 0
Hospital
Name [1] 313831 0
TR HSU Diyarbakir Gazi Yasargil TRH
Country [1] 313831 0
Turkey
Funding source category [2] 313846 0
Hospital
Name [2] 313846 0
University of Health Sciences
Country [2] 313846 0
Turkey
Primary sponsor type
Hospital
Name
TR HSU Diyarbakir Gazi Yasargil TRH
Address
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code:21070, Kayapinar/Diyarbakir
Country
Turkey
Secondary sponsor category [1] 315666 0
Individual
Name [1] 315666 0
Fatma Acil
Address [1] 315666 0
TR HSU Diyarbakir Gazi Yasargil TRH
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code:21070, Kayapinar/Diyarbakir
Country [1] 315666 0
Turkey

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312989 0
TR HSU Diyarbakir Gazi Yasargil TRH Ethic Committee
Ethics committee address [1] 312989 0
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Ethics committee country [1] 312989 0
Turkey
Date submitted for ethics approval [1] 312989 0
16/05/2023
Approval date [1] 312989 0
Ethics approval number [1] 312989 0

Summary
Brief summary
This study aims to determine the most effective and long-lasting pain relief method for post-operative analgesia in kidney donor and recipient patients in kidney transplantation programme with the least invasive and least drug administration.
For this reason, it is planned to perform Quadratus lumborum plane block (QLB) in a group of patients who will be kidney donors and kidney recipients in kidney transplantation and who meet the ASA1-3 risk classification between the ages of 18-70 years, and to administer intravenous pain medication without block in another group. It is planned to include at least 84 patients in the Quadratus lumborum plan block (QLB) and Intravenous Analgesia group (IVA) without gender discrimination.
Postoperative Sedation-Agitation assessment and NRS (numeric pain scale) at 1st hour, 2nd, 6th, 12th and 24th hours, as well as possible side effects such as nausea, vomiting, shoulder pain, respiratory depression, bradycardia and hypotension, total amount of opioid analgesics consumed within 24 hours and duration of hospital stay will be observed and recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126598 0
Dr Fatma Acil
Address 126598 0
TR HSU Diyarbakir Gazi Yasargil TRH
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Country 126598 0
Turkey
Phone 126598 0
+90 533 722 5225
Fax 126598 0
+90 0412 2519128
Email 126598 0
fatma.acil@saglik.gov.tr
Contact person for public queries
Name 126599 0
Prof Osman Ekinci
Address 126599 0
University of Health Sciences
Mekteb-i Tibbiye-i Sahane (Hamidiye) Külliyesi Selimiye Mah. Tibbiye Cad. No:38 34668 Üsküdar, Istanbul
Country 126599 0
Turkey
Phone 126599 0
+90 216 777 8 777
Fax 126599 0
Email 126599 0
info@sbu.edu.tr
Contact person for scientific queries
Name 126600 0
Dr Fatma Acil
Address 126600 0
TR HSU Diyarbakir Gazi Yasargil TRH
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Country 126600 0
Turkey
Phone 126600 0
+90 533 722 5225
Fax 126600 0
Email 126600 0
fatma.acil@saglik.gov.tr

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; individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
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: fatma.acil@saglik.gov.tr )


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.