Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001031550
Ethics application status
Approved
Date submitted
16/06/2024
Date registered
27/08/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
27/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Quadratus Lumborum Block for Postoperative Pain in Transurethral Resection of Bladder Tumors
Scientific title
The Effect of Ultrasound-Guided Anterior and Posterior Quadratus Lumborum Blocks on Postoperative Pain Management in Patients Undergoing Transurethral Resection of Bladder Tumor
Secondary ID [1] 312307 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain management 334056 0
bladder tumor 334335 0
Condition category
Condition code
Anaesthesiology 330725 330725 0 0
Pain management
Anaesthesiology 330726 330726 0 0
Anaesthetics
Renal and Urogenital 330989 330989 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, 105 patients undergoing elective transurethral bladder tumor resection under spinal anesthesia will be randomly assigned to 3 groups. Group A will be received ultrasound-guided anterior quadratus lumborum block (QLB) where the local anesthetic is injected anterior to the QL muscle with 0.25% 20 mL bupivacaine each side and group B will be received ultrasound-guided posterior QLB where the local anesthetic is injected posterior to the QL muscle with 0.25% 20 mL bupivacaine each side by one of two experienced anesthesiologists who will not participate in the rest of the study. Group C will be received a placebo. Local anesthetic doses are determined by the anesthesiologist performing the procedure in accordance with clinical studies in the literature. All injection procedures will be performed once as soon as the surgery is completed. Patients will be monitored by the nurse and doctor in the 24-hour period after the procedure and the parameters will be noted for evaluation. The block procedures mentioned above and postoperative pain monitoring are routine procedures, and medical records will be reviewed in the study. The investigator will not be involved in patient care, preoperative evaluation, or data collection but will use a random sequence of numbers to randomize patients.
Intervention code [1] 328780 0
Treatment: Other
Comparator / control treatment
In the control group (group C) will be received bilateral sham ultrasound-guided QLB via an injection of 1 mL of normal saline after surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 338484 0
time to first analgesic request
Timepoint [1] 338484 0
24 hours after the surgery
Primary outcome [2] 338485 0
total opioid consumption
Timepoint [2] 338485 0
24 hours after the surgery
Secondary outcome [1] 436112 0
postoperative side effects
Timepoint [1] 436112 0
24 hours after the surgery
Secondary outcome [2] 436247 0
additional analgesic requirement
Timepoint [2] 436247 0
24 hours after the surgery

Eligibility
Key inclusion criteria
Patients who are aged between 20 to 75 years with a body mass index (BMI) of 20-30 kg/m2, who are included in the American Society of Anesthesiologists Physical Status I-II-III classes will be scheduled elective transurethral bladder tumor resection under spinal anesthesia.
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with coagulation abnormalities, local anesthetic allergy, systemic or puncture site infections, alcohol and drug addictions, inability to accurately cooperate in pain assessments due to cognitive dysfunction, liver or kidney failure and persistent pain more than 3 months will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation procedure such as coin-tossing will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
1/09/2024
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
105
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 26374 0
Turkey
State/province [1] 26374 0
Istanbul

Funding & Sponsors
Funding source category [1] 316700 0
Self funded/Unfunded
Name [1] 316700 0
unfunded
Country [1] 316700 0
Primary sponsor type
Hospital
Name
Health Sciences Istanbul Training and Research Hospital
Address
Country
Turkey
Secondary sponsor category [1] 318902 0
None
Name [1] 318902 0
Address [1] 318902 0
Country [1] 318902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315480 0
Bezmialem Vakif University Clinical Research Ethics Committee
Ethics committee address [1] 315480 0
Ethics committee country [1] 315480 0
Turkey
Date submitted for ethics approval [1] 315480 0
10/07/2024
Approval date [1] 315480 0
26/08/2024
Ethics approval number [1] 315480 0
2024-KAEK-03

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

Contacts
Principal investigator
Name 134822 0
Dr Iremgul Nalbat
Address 134822 0
Kasap Ilyas Mah. Org Nafiz Gurman Cd. Istanbul Training and Research Hospital (Istanbul Egitim ve Arastirma Hastanesi) Yogun Bakim Klinigi
Country 134822 0
Turkey
Phone 134822 0
+905303899471
Fax 134822 0
Email 134822 0
[email protected]
Contact person for public queries
Name 134823 0
Iremgul Nalbat
Address 134823 0
Kasap Ilyas Mah. Org Nafiz Gurman Cd. Istanbul Training and Research Hospital (Istanbul Egitim ve Arastirma Hastanesi) Yogun Bakim Klinigi
Country 134823 0
Turkey
Phone 134823 0
+905303899471
Fax 134823 0
Email 134823 0
[email protected]
Contact person for scientific queries
Name 134824 0
Iremgul Nalbat
Address 134824 0
Kasap Ilyas Mah. Org Nafiz Gurman Cd. Istanbul Training and Research Hospital (Istanbul Egitim ve Arastirma Hastanesi) Yogun Bakim Klinigi
Country 134824 0
Turkey
Phone 134824 0
+905303899471
Fax 134824 0
Email 134824 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24222Ethical approval    387941-(Uploaded-30-09-2024-16-55-55)-12-9. 2024-52 (Sorumlu Arastirmaci Veysel ERDEN).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.