Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000546257
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
12/04/2018
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Date results information initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effect of preoperative continue femoral nerve block and paracetamol administration on preoperative pain management and postoperative delirium incidence of geriatric patients
Scientific title
Comparison of the effect of preoperative continue femoral nerve block and paracetamol administration on preoperative pain management and postoperative delirium incidence of geriatric patients scheduled for trochanteric femur fracture
Secondary ID [1] 291313 0
None
Universal Trial Number (UTN)
U1111-1193-6260
Trial acronym
FNBT (Femoral Nerve Block Trial)
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 302287 0
Delirium 302288 0
Condition category
Condition code
Anaesthesiology 304478 304478 0 0
Pain management
Neurological 304479 304479 0 0
Other neurological disorders
Injuries and Accidents 305861 305861 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who are older than 65 years old and applied to emergency service with hip fracture diagnosis will be included in the study. All of the patients will be assessed for the presence of delirium with 16 items Delirium Rating Scale-Revised Version (DRS-R-98). The patients with preoperative delirium will be excluded from the study. The participants will receive 2 lt/minute oxygen supplementation and standard nutritional support. Preoperative hemoglobin level will be raised to 10 g/dl in all of the patients prior to the surgery. Then the patients will randomly be divided into two groups; in the first group, patients will receive 5 mg/kg paracetamol intraveously at every 8 hours until the operation day (maximum 48 hours). In the second group, a femoral nerve block will be done with the guidance of ultrasonography and a catheter will be inserted, then 0.5 ml/kg bupivacaine %0.25 will be administered through the femoral nerve catheter until the operation day (maximum 48 hours). The pain levels of the patients will be assessed using a 100mm visual analog scale four hours after the paracetamol administration in the first group and femoral block in the second group. If needed, intravenous tramadol 0.5 mg/kg will be applied as rescue analgesic in both of the groups. In the operating room, all of the patients will receive a spinal-epidural combined anesthesia as anesthetic management. The pain occurred related to positioning for regional anesthesia will be recorded using a 100mm visual analogue scale. During the dural puncture, 2 ml of cerebrospinal fluid will be taken for analysis of interleukin 6 and interleukin 8 levels with enzyme linked immunoassay. For spinal anesthesia, 10 mg bupivacaine and 20 mcg fentanyl will be applied intrathecaly. The postoperative analgesia will be managed with 5 ml/hour of bupivacaine 0.125% and 100 mcg fentanyl through the epidural catheter in all the patients. The patients will be assessed with DRS-R-98 for presence of delirium at postoperative first, second and third days.
Intervention code [1] 299939 0
Treatment: Drugs
Comparator / control treatment
In the control (paracetamol) group, patients will receive 15 mg/kg paracetamol intravenously at every 8 hours until de operation day (maximum 48 hours)..In the operating room, spinal-epidural combined anesthesia will be done to all of the patients.
Control group
Active

Outcomes
Primary outcome [1] 304316 0
Postoperative delirium incidence as assessed by 16 items Delirium Rating Scale-Revised Version after pain management with paracetamol infusion or femoral nerve block
Timepoint [1] 304316 0
At the postoperative first, second and third (primary timepoint) days
Secondary outcome [1] 341570 0
interleukin 6 levels in cerebrospinal fluid
Timepoint [1] 341570 0
At the postoperative first, second and third (secondary timepoint) days
Secondary outcome [2] 343577 0
interleukin 8 levels in cerebrospinal fluid
Timepoint [2] 343577 0
At the postoperative first, second and third days (secondary timepoint)
Secondary outcome [3] 343578 0
Pain scores as assessed by 100mm Visual analogue scale after the paracetamol infusion of femoral nerve block
Timepoint [3] 343578 0
Four hours after the start of pain management
Secondary outcome [4] 343579 0
Pain scores as assessed by 100mm Visual analogue scale after the paracetamol infusion of femoral nerve block
Timepoint [4] 343579 0
During positioning for spinal anesthesia in the operating room

Eligibility
Key inclusion criteria
Age over 65, ASA status II-IV, diagnosis of hip fracture
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of preoperative delirium, hip fracture related to malignancy, known allergy to paracetamol and bupivacaine, parkinson's disease, presence of a contraindication for regional anesthesia, epilepsy, cholinesterase inhibitor use

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)
central randomisation by 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
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
Efficacy
Statistical methods / analysis
Statistical analyses of the data will be performed by using SPSS (statistical package for social sciences for Windows 16.0). The normality of the variables will be analyzed with Kolmogorov-Smirnov test. One-way ANOVA test for parametric variables with normal distribution will be used to compare the means between the groups. The analysis of the variables with abnormal distribution will be done with Wilcoxon test. A value of p < 0.05 was considered statistically significant. The results are expressed as means ± standard errors.
The power analysis of the study was calculated based on previous studies about delirium development after hip fractures. Approximately 45 patients in each group were required for a power of 0.80 and a=0.05 for detecting a 20% difference in delirium incidence between groups at postoperative 3. day. Assuming drop-outs, we decided to include 55 patients to each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2018
Actual
15/04/2018
Date of last participant enrolment
Anticipated
15/05/2018
Actual
14/08/2018
Date of last data collection
Anticipated
18/05/2018
Actual
17/08/2018
Sample size
Target
110
Accrual to date
Final
91
Recruitment outside Australia
Country [1] 9463 0
Turkey
State/province [1] 9463 0
Mugla

Funding & Sponsors
Funding source category [1] 295781 0
Hospital
Name [1] 295781 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 295781 0
Turkey
Primary sponsor type
Individual
Name
Ali Ihsan UYSAL
Address
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country
Turkey
Secondary sponsor category [1] 294630 0
None
Name [1] 294630 0
Address [1] 294630 0
Country [1] 294630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297079 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 297079 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Ethics committee country [1] 297079 0
Turkey
Date submitted for ethics approval [1] 297079 0
04/04/2016
Approval date [1] 297079 0
27/04/2016
Ethics approval number [1] 297079 0
Approval number: III

Summary
Brief summary
Our primary aim in this study is to evaluate the effect of early pain management after hip fracture with either continuous femoral nerve block or paracetamol infusion on postoperative delirium incidence. Our secondary aim is to determine the relation between postoperative delirium incidence and interleukin 6 and interleukin 8 levels in cerebrospinal fluid.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72902 0
Dr Ali Ihsan Uysal
Address 72902 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 72902 0
Turkey
Phone 72902 0
+905067020960
Fax 72902 0
Email 72902 0
alihsanuysal@gmail.com
Contact person for public queries
Name 72903 0
Ali Ihsan Uysal
Address 72903 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 72903 0
Turkey
Phone 72903 0
+905067020960
Fax 72903 0
Email 72903 0
alihsanuysal@gmail.com
Contact person for scientific queries
Name 72904 0
Ali Ihsan Uysal
Address 72904 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 72904 0
Turkey
Phone 72904 0
+905067020960
Fax 72904 0
Email 72904 0
alihsanuysal@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication on request and ending 1 year following publication.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


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.