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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
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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
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Secondary ID [1]
309647
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none
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Universal Trial Number (UTN)
U1111-1292-5270
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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 transplant
329981
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Condition category
Condition code
Anaesthesiology
326888
326888
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0
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Pain management
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Renal and Urogenital
327137
327137
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326088
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Prevention
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Intervention code [2]
326089
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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assessment of pain (NRS) level at 1st, 2nd, 6th, 12th, 24th postoperative hours
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Assessment method [1]
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Timepoint [1]
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postoperative 1st, 2nd, 6th, 12th, 24th hours
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Primary outcome [2]
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total postoperative tramadol consumption
these data will be collected from review of medical records
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Assessment method [2]
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Timepoint [2]
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within 24 hours postoperatively
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Secondary outcome [1]
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sedation- agitation level after extubation
these data will be collected from review of medical records
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Assessment method [1]
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Timepoint [1]
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after extubation
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Secondary outcome [2]
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measurement of blood pressure at 1st, 2nd, 6th, 12th, 24th postoperative hours
these data will be collected from review of medical records
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Assessment method [2]
421918
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Timepoint [2]
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at 1st, 2nd, 6th, 12th, 24th postoperative hours
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Secondary outcome [3]
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measurement of heart rate at 1st, 2nd, 6th, 12th, 24th postoperative hours
these data will be collected from review of medical records
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Assessment method [3]
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Timepoint [3]
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at 1st, 2nd, 6th, 12th, 24th postoperative hours
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Secondary outcome [4]
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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.
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Assessment method [4]
421920
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Timepoint [4]
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at the end of 24 hours postoperatively
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Secondary outcome [5]
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blood pressure measurement every 15 minutes during surgery
these data will be collected from review of medical records
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Assessment method [5]
421921
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Timepoint [5]
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during surgery
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Secondary outcome [6]
421922
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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
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Assessment method [6]
421922
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Timepoint [6]
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during surgery
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Secondary outcome [7]
421923
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amount of fentanyl consumed during the operation
these data will be collected from review of medical records
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Assessment method [7]
421923
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Timepoint [7]
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during surgery
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Secondary outcome [8]
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nausea-vomiting
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Assessment method [8]
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Timepoint [8]
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Will be followed from the postoperative period until discharge
Data evaluation will be obtained from service follow-up forms.
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Secondary outcome [9]
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Shoulder pain
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Assessment method [9]
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Timepoint [9]
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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
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Secondary outcome [10]
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Respiratory distress
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Assessment method [10]
422701
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Timepoint [10]
422701
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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
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Secondary outcome [11]
422702
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Length of hospital stay
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Assessment method [11]
422702
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Timepoint [11]
422702
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These data will be collected from review of medical records
Data will be obtained at discharge from hospital
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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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)
Sealed opaque envelopes
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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 (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
27/07/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
84
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
25502
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Turkey
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State/province [1]
25502
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Diyarbakir
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
313831
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TR HSU Diyarbakir Gazi Yasargil TRH
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Address [1]
313831
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Elazig Yolu 10. Km Üçkuyular Mevkii, zip code:21070, Kayapinar/Diyarbakir
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Country [1]
313831
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Turkey
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Funding source category [2]
313846
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Hospital
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Name [2]
313846
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University of Health Sciences
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Address [2]
313846
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Mekteb-i Tibbiye-i Sahane (Hamidiye) Külliyesi Selimiye Mah. Tibbiye Cad. No:38 34668 Üsküdar, Istanbul
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Country [2]
313846
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Turkey
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Primary sponsor type
Hospital
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Name
TR HSU Diyarbakir Gazi Yasargil TRH
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Address
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code:21070, Kayapinar/Diyarbakir
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Country
Turkey
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Secondary sponsor category [1]
315666
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Individual
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Name [1]
315666
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Fatma Acil
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Address [1]
315666
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TR HSU Diyarbakir Gazi Yasargil TRH
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code:21070, Kayapinar/Diyarbakir
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Country [1]
315666
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Turkey
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
312989
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TR HSU Diyarbakir Gazi Yasargil TRH Ethic Committee
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Ethics committee address [1]
312989
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Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
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Ethics committee country [1]
312989
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Turkey
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Date submitted for ethics approval [1]
312989
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16/05/2023
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Approval date [1]
312989
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Ethics approval number [1]
312989
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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.
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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
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Dr Fatma Acil
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Address
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TR HSU Diyarbakir Gazi Yasargil TRH
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
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Country
126598
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Turkey
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Phone
126598
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+90 533 722 5225
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Fax
126598
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+90 0412 2519128
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Email
126598
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[email protected]
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Contact person for public queries
Name
126599
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Prof Osman Ekinci
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Address
126599
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University of Health Sciences
Mekteb-i Tibbiye-i Sahane (Hamidiye) Külliyesi Selimiye Mah. Tibbiye Cad. No:38 34668 Üsküdar, Istanbul
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Country
126599
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Turkey
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Phone
126599
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+90 216 777 8 777
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Fax
126599
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Email
126599
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[email protected]
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Contact person for scientific queries
Name
126600
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Dr Fatma Acil
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Address
126600
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TR HSU Diyarbakir Gazi Yasargil TRH
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
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Country
126600
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Turkey
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Phone
126600
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+90 533 722 5225
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Fax
126600
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Email
126600
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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)?
Yes
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What data in particular will be shared?
after de-identification; individual participant data underlying published results only
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
only to achieve the aims in the approved proposal
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How or where can data be obtained?
access subject to approvals by Principal Investigator (e-mail:
[email protected]
)
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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.
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