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Trial registered on ANZCTR


Registration number
ACTRN12623000714684
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
5/07/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the efficacy of quadratus lumborum and transverse abdominis plane blocks applied to prevent postoperative pain in closed gallbladder operations with intravenous painkillers
Scientific title
Comparison of the Efficacy of Bilateral Transverse Abdominis plane block (TAPB) and Bilateral Quadratus lumborum block (QLB) with Intravenous analgesic (IVA) group for Preemptive Analgesia in Laparoscopic Cholecystectomy Surgery
Secondary ID [1] 309443 0
none
Universal Trial Number (UTN)
U1111-1292-2216
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cholecystitis 330228 0
Condition category
Condition code
Anaesthesiology 326654 326654 0 0
Pain management
Oral and Gastrointestinal 327099 327099 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-Group QLB (quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides
2- Group TAPB (transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides

- Medical records will be audited to monitor adherence to the intervention.
-each patient will be administered 0.25% bupivacaine for each side (a total of 40 ml of 0.25% bupivacaine will be used)
- 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.
- Plane block applications will be applied only once in the preoperative period.
- 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 Visual Analogue Scale (VAS) 4 despite this.
- This study will be followed up in the general surgery unit of Health Sciences University Gazi Yasargil Training and Research Hospital.
- Patients will be 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 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.
- Both plane blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.
Intervention code [1] 325914 0
Prevention
Intervention code [2] 326245 0
Treatment: Surgery
Comparator / control treatment
Group IVA: Patients in this group will be administered 1 g paracetamol + 100 mg tramadol intravenously by the anesthesiologist 15 minutes before extubation after the end of surgery.
Control group
Active

Outcomes
Primary outcome [1] 334521 0
postoperative total tramadol consumption
data will be collected from review of medical records and nurse observation forms
Timepoint [1] 334521 0
first 24 hours postoperatively
Primary outcome [2] 334524 0
VAS value of abdominal pain
Timepoint [2] 334524 0
postoperatively, 30th minute, 2nd hour, 4th hour, 12th hour, 24th hour
Secondary outcome [1] 420986 0
postoperative Rickers sedation agitation score (RSAS) value
Timepoint [1] 420986 0
during extubation
Secondary outcome [2] 420987 0
intraoperative fentanyl consumption
data will be collected from review of medical records
Timepoint [2] 420987 0
during surgery
Secondary outcome [3] 420988 0
postoperative nausea and vomiting
data will be collected from review of medical records and clinical assessment of patients
Timepoint [3] 420988 0
postoperatively, 30th minute, 2nd hour, 4th hour, 12th hour, 24th hour
Secondary outcome [4] 420989 0
postoperative shoulder pain
shoulder pain patients will be asked to verbally assess whether there is pain or not
Timepoint [4] 420989 0
postoperatively, 30th minute, 2nd hour, 4th hour, 12th hour, 24th hour
Secondary outcome [5] 420990 0
surgical duration
data will be collected from review of medical records
Timepoint [5] 420990 0
At the completion of surgery
Secondary outcome [6] 420991 0
anaesthesia duration
data will be collected from review of medical records
Timepoint [6] 420991 0
At the completion of surgery
Secondary outcome [7] 421666 0
length of hospital stay
data will be collected from review of medical records
Timepoint [7] 421666 0
At time of hospital discharge

Eligibility
Key inclusion criteria
Aged 18-70 years, who will undergo laparoscopic cholecystectomy and who meet the ASA1-3 risk classification
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA above 3
Age < 18 or >70 years
patient's reluctance

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 128.
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
5/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
48
Final
Recruitment outside Australia
Country [1] 25402 0
Turkey
State/province [1] 25402 0
Diyarbakir

Funding & Sponsors
Funding source category [1] 313639 0
University
Name [1] 313639 0
TR HSU Diyarbakir Gazi Yasargil TRH
Country [1] 313639 0
Turkey
Primary sponsor type
Individual
Name
Fatma Acil
Address
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070 Kayapinar/Diyarbakir
Country
Turkey
Secondary sponsor category [1] 315433 0
Hospital
Name [1] 315433 0
TR HSU Diyarbakir Gazi Yasargil TRH
Address [1] 315433 0
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070 Kayapinar/Diyarbakir
Country [1] 315433 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312807 0
TR HSU Diyarbakir Gazi Yasargil TRH Ethic Committee
Ethics committee address [1] 312807 0
Elazig Yolu 10. Km Üçkuyular Mevkii, Zip code: 21070 ,Kayapinar/Diyarbakir
Ethics committee country [1] 312807 0
Turkey
Date submitted for ethics approval [1] 312807 0
26/12/2022
Approval date [1] 312807 0
03/03/2023
Ethics approval number [1] 312807 0
372

Summary
Brief summary
It is aimed that patients who will undergo laparoscopic gallbladder surgery will experience less pain after surgery and require less morphine-derived painkillers. In relation to this, it is expected to reduce the risk of side effects such as nausea, vomiting, shoulder pain, shortness of breath after surgery.
To achieve this, we aim to determine the most effective and long-lasting pain relief method.
For this reason, a total of 128 patients between the ages of 18-70 who will undergo gallbladder surgery were planned to be included in the study, including one group of patients with transabdominis plane block (TAPB), one group of patients with Quadratus lumborum plane block (QLB) and one group of patients with intravenous painkillers (IVA).
In addition to postoperative agitation assessment and visual pain assessment at 30 minutes, 2, 4, 12 and 24 hours, possible side effects such as nausea, vomiting, shoulder pain, respiratory distress, pulse and blood pressure drop will be observed and recorded. In addition, the total amount of morphine-derived painkillers consumed in the first 24 hours after surgery and the duration of hospital stay will be observed and recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125994 0
Dr Fatma Acil
Address 125994 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute : Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 125994 0
Turkey
Phone 125994 0
+90 533 722 5225
Fax 125994 0
Email 125994 0
fatma.acil@saglik.gov.tr
Contact person for public queries
Name 125995 0
Dr Fatma Acil
Address 125995 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute : Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 125995 0
Turkey
Phone 125995 0
+90 533 722 5225
Fax 125995 0
Email 125995 0
fatma.acil@saglik.gov.tr
Contact person for scientific queries
Name 125996 0
Dr Fatma Acil
Address 125996 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute : Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 125996 0
Turkey
Phone 125996 0
+90 533 722 5225
Fax 125996 0
+90 412 2519128
Email 125996 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 all individual de-identifications were made; all individual participant data collected during the study:
age, weight, height, body mass index, amount of fentanyl consumed during surgery, amount of intravenous tramadol consumed within 24 hours after surgery, sedation-agitation score after extubation, pain score (visual analogue scale) at 30 minutes, 2 hours, 4 hours, 12 hours and 24 hours a
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wants to access
Available for what types of analyses?
only to achieve the objectives in the approved proposal
How or where can data be obtained?
Access subject to the approval of the Principal Investigator (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.