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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
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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
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Secondary ID [1]
309443
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none
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Universal Trial Number (UTN)
U1111-1292-2216
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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:
cholecystitis
330228
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Condition category
Condition code
Anaesthesiology
326654
326654
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0
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Pain management
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Oral and Gastrointestinal
327099
327099
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
325914
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Prevention
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Intervention code [2]
326245
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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postoperative total tramadol consumption
data will be collected from review of medical records and nurse observation forms
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Assessment method [1]
334521
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Timepoint [1]
334521
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first 24 hours postoperatively
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Primary outcome [2]
334524
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VAS value of abdominal pain
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Assessment method [2]
334524
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Timepoint [2]
334524
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postoperatively, 30th minute, 2nd hour, 4th hour, 12th hour, 24th hour
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Secondary outcome [1]
420986
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postoperative Rickers sedation agitation score (RSAS) value
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Assessment method [1]
420986
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Timepoint [1]
420986
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during extubation
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Secondary outcome [2]
420987
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intraoperative fentanyl consumption
data will be collected from review of medical records
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Assessment method [2]
420987
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Timepoint [2]
420987
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during surgery
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Secondary outcome [3]
420988
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postoperative nausea and vomiting
data will be collected from review of medical records and clinical assessment of patients
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Assessment method [3]
420988
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Timepoint [3]
420988
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postoperatively, 30th minute, 2nd hour, 4th hour, 12th hour, 24th hour
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Secondary outcome [4]
420989
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postoperative shoulder pain
shoulder pain patients will be asked to verbally assess whether there is pain or not
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Assessment method [4]
420989
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Timepoint [4]
420989
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postoperatively, 30th minute, 2nd hour, 4th hour, 12th hour, 24th hour
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Secondary outcome [5]
420990
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surgical duration
data will be collected from review of medical records
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Assessment method [5]
420990
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Timepoint [5]
420990
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At the completion of surgery
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Secondary outcome [6]
420991
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anaesthesia duration
data will be collected from review of medical records
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Assessment method [6]
420991
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Timepoint [6]
420991
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At the completion of surgery
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Secondary outcome [7]
421666
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length of hospital stay
data will be collected from review of medical records
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Assessment method [7]
421666
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Timepoint [7]
421666
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At time of hospital discharge
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Eligibility
Key inclusion criteria
Aged 18-70 years, who will undergo laparoscopic cholecystectomy and who meet the ASA1-3 risk classification
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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?
No
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Key exclusion criteria
ASA above 3
Age < 18 or >70 years
patient's reluctance
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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)
central randomisation by phone/fax/computer
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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/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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
5/06/2023
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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
128
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Accrual to date
48
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Final
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Recruitment outside Australia
Country [1]
25402
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Turkey
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State/province [1]
25402
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Diyarbakir
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Funding & Sponsors
Funding source category [1]
313639
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University
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Name [1]
313639
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TR HSU Diyarbakir Gazi Yasargil TRH
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Address [1]
313639
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Elazig Yolu 10. Km Üçkuyular Mevkii
21070 Kayapinar/Diyarbakir
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Country [1]
313639
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Turkey
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Primary sponsor type
Individual
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Name
Fatma Acil
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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]
315433
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Hospital
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Name [1]
315433
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TR HSU Diyarbakir Gazi Yasargil TRH
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Address [1]
315433
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Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070 Kayapinar/Diyarbakir
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Country [1]
315433
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Turkey
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312807
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TR HSU Diyarbakir Gazi Yasargil TRH Ethic Committee
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Ethics committee address [1]
312807
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Elazig Yolu 10. Km Üçkuyular Mevkii, Zip code: 21070 ,Kayapinar/Diyarbakir
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Ethics committee country [1]
312807
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Turkey
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Date submitted for ethics approval [1]
312807
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26/12/2022
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Approval date [1]
312807
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03/03/2023
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Ethics approval number [1]
312807
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372
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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.
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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, Department of Anesthesiology and Reanimation
Address of the institute : Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
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Country
125994
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Turkey
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Phone
125994
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+90 533 722 5225
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Fax
125994
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Email
125994
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[email protected]
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Contact person for public queries
Name
125995
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Fatma Acil
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Address
125995
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TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute : Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
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Country
125995
0
Turkey
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Phone
125995
0
+90 533 722 5225
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Fax
125995
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Email
125995
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[email protected]
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Contact person for scientific queries
Name
125996
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Fatma Acil
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Address
125996
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TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation
Address of the institute : Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
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Country
125996
0
Turkey
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Phone
125996
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+90 533 722 5225
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Fax
125996
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+90 412 2519128
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Email
125996
0
[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 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
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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?
anyone who wants to access
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Available for what types of analyses?
only to achieve the objectives in the approved proposal
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How or where can data be obtained?
Access subject to the approval of the Principal Investigator (
[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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