Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000674639
Ethics application status
Approved
Date submitted
8/05/2023
Date registered
22/06/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
22/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of intraoperative and postoperative effects of pericapsular nerve group (PENG) block and fascia ilicaca block before spinal anaesthesia in hip fracture cases
Scientific title
The effects of pericapsular nerve group (PENG) block and fascia iliaca plan block on preoperative and postoperative analgesia before spinal anaesthesia in patients undergoing hip fracture surgery
Secondary ID [1] 309623 0

none
Universal Trial Number (UTN)
U1111-1292-3023
Trial acronym
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 329942 0
Condition category
Condition code
Anaesthesiology 326850 326850 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1:Pericapsular nerve group (PENG) block: Using an in-plane approach with ultrasonographic imaging, the block needle reaches the fascial plane between the psoas muscle and the superior pubic ramus and local anaesthetic solution is injected.

Breif name: Comparison of plane blocks in hip surgery

- Each patient will receive 15 ml of 0.375% bupivacaine 0.375% on the side of the broken hip only one time approximately 15-20 minutes before the operation.
- plane blocks will be applied under ultrasound guidance.
- plane block will be applied with the patient in supine position.
- 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 VAS 4 despite this.
- This study was followed up in the orthopaedic service of SBU Gazi Yasargil Training and Research Hospital.
- After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied.

Patients will be monitored for pain and side effects at the postanesthetic care unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
- The extent to which plan blocks facilitate the positioning of the patient for spinal anaesthesia in the intraoperative period will be monitored. In addition, the effects on intraoperative and postoperative opioid consumption and patient satisfaction will be observed.

Intervention code [1] 326049 0
Prevention
Intervention code [2] 326050 0
Treatment: Other
Comparator / control treatment
Group 2: Suprainguinal fascia iliaca plane block: The needle entering in plane from the caudal end of the ultrasound probe passes through the m. sartorius and into the musculus iliacus and fascia iliaca reaches. The fascia iliaca is passed with the needle and local anaesthetic solution is injected immediately under the fascia.

- Each patient will receive 15 ml of 0.375% bupivacaine 0.375% on the side of the broken hip only one time approximately 15-20 minutes before the operation.
- plane blocks will be applied under ultrasound guidance.
- plane block will be applied with the patient in supine position.
- 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 VAS 4 despite this.
- This study was followed up in the orthopaedic service of SBU Gazi Yasargil Training and Research Hospital.
- After the patients were sedated with intravenous 1 mg midazolam and 50 mcg fentanyl in the preoperative preparation room, 15 ml of 0.375% bupivacaine was administered to the fractured hip side under ultrasound guidance. After the block application, the patient will be taken to the operating room and standard spinale anaesthesia will be applied.

Patients will be monitored for pain and side effects at the postanesthetic care unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
-The extent to which plan blocks facilitate the positioning of the patient for spinal anaesthesia in the intraoperative period will be monitored. In addition, the effects on intraoperative and postoperative opioid consumption and patient satisfaction will be observed.
Control group
Active

Outcomes
Primary outcome [1] 334699 0
Pain assessment with the Numerical Rating Scale (NRS)
Timepoint [1] 334699 0
NRS1: measured in neutral position before the block.
NRS2: measured with 15 degrees elevation of the affected limb before the block.
NRS3: Measured in spinal positioning.
NRS4: Measured between 0-2 hours postoperatively.
NRS5: Measured between 2-8 hours postoperatively.
NRS6: Measured between 8-24 hours postoperatively.
Primary outcome [2] 334700 0
Evaluation of ease of positioning
Evaluation of ease of positioning via study-specific questionnaire
Timepoint [2] 334700 0
at the stage of introduction of spinal anaesthesia
Secondary outcome [1] 421791 0
Agitation assessment with Richmond Agitation Sedation Scale
Timepoint [1] 421791 0
During positioning for spinal anaesthesia
Secondary outcome [2] 421792 0
mean blood pressure
Mean blood pressure assessed using automatic sphygmomanometer over a 60 second interval
Timepoint [2] 421792 0
1- Baseline
2- During spinal block
3- 5th minutes after spinal block
4- Every 10 minutes during the operation
5- Skin closure
Secondary outcome [3] 421793 0
heart rate
Heart rate assessed using automatic telemetry readings
Timepoint [3] 421793 0
1- Baseline
2- During spinal block
3- 5th minutes after spinal block
4- Every 10 minutes during the operation
5- Skin closure
Secondary outcome [4] 421794 0
Tamadol consumption after surgery
Tramadol consumption after surgery is assessed using patient medical records
Timepoint [4] 421794 0
24 hours postoperatively
Secondary outcome [5] 421795 0
Time of first analgesia use
The time of first analgesia use will be assessed using patient medical records
Timepoint [5] 421795 0
Time of first analgesia use postoperatively
Secondary outcome [6] 421796 0
Side effects such as neurological deficit, oedema, haematoma, nausea and vomiting will be evaluated by physical examination, patient anamnesis and nurse follow-up forms
Timepoint [6] 421796 0
within 24 hours postoperatively
Secondary outcome [7] 421797 0
Patient satisfaction score
Patients' satisfaction with the quality of pain management will be assessed on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = quite unsatisfied; 3 = moderate; 4 = quite satisfactory; 5 = very satisfactory.
Timepoint [7] 421797 0
second postoperative day
Secondary outcome [8] 421798 0
Limb range of motion
Limb range of motion assessed using goniometer
Timepoint [8] 421798 0
Postoperative 4th hour

Postoperative 8th hour

Eligibility
Key inclusion criteria
Patients between 18-70 years of age, ASA I-III, scheduled for hip fracture surgery under spinal anaesthesia.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA >III
known allergy to local anaesthetics
presence of preoperative chronic pain
presence of coagulopathy
those who are unable to give written consent

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 52.
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
3/07/2023
Actual
3/07/2023
Date of last participant enrolment
Anticipated
30/08/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
52
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 25491 0
Turkey
State/province [1] 25491 0
Diyarbakir

Funding & Sponsors
Funding source category [1] 313804 0
University
Name [1] 313804 0
TR HSU Diyarbakir Gazi Yasargil TRH
Country [1] 313804 0
Turkey
Primary sponsor type
Hospital
Name
Health Sciences University Training and Research Hospital
Address
Saglik Bilimleri Üniversitesi Hamidiye Uluslararasi Tip Fakültesi Mekteb-i Tibbiye-i Sahane (Haydarpasa) Külliyesi Selimiye Mah. Tibbiye Cad. 34668 Üsküdar, Istanbul
Country
Turkey
Secondary sponsor category [1] 315635 0
University
Name [1] 315635 0
TR HSU Diyarbakir Gazi Yasargil TRH
Address [1] 315635 0
Address: Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Country [1] 315635 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312969 0
TR HSU Diyarbakir Gazi Yasargil TRH Ethic Committee
Ethics committee address [1] 312969 0
Ethics committee country [1] 312969 0
Turkey
Date submitted for ethics approval [1] 312969 0
10/10/2022
Approval date [1] 312969 0
09/12/2022
Ethics approval number [1] 312969 0
265

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

Contacts
Principal investigator
Name 126526 0
A/Prof Cem Kivilcim Kaçar
Address 126526 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation, Turkey
Address of the institute (Zip code: 21070): Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 126526 0
Turkey
Phone 126526 0
+90 533 020 6362
Fax 126526 0
Email 126526 0
[email protected]
Contact person for public queries
Name 126527 0
Osman Ekinci
Address 126527 0
Saglik Bilimleri Üniversitesi Hamidiye Uluslararasi Tip Fakültesi Mekteb-i Tibbiye-i Sahane (Haydarpasa) Külliyesi Selimiye Mah. Tibbiye Cad. 34668 Üsküdar, Istanbul
Country 126527 0
Turkey
Phone 126527 0
+90 216 777 92 00
Fax 126527 0
Email 126527 0
[email protected]
Contact person for scientific queries
Name 126528 0
Fatma Acil
Address 126528 0
TR HSU Diyarbakir Gazi Yasargil TRH, Department of Anesthesiology and Reanimation, Turkey
Address of the institute (Zip code: 21070): Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 126528 0
Turkey
Phone 126528 0
+90 533 722 5225
Fax 126528 0
Email 126528 0
[email protected]

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)?
data can be shared Immediately following publication.
no end date determined.
Available to whom?
On a case-by-case basis at the discretion of the Main Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


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.