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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05549011
Other study ID # 326
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2022
Est. completion date January 20, 2023

Study information

Verified date March 2023
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to compare the effectiveness of preoperative ultrasound-guided suprainguinal fascia iliaca compartment block (SFICB) and pericapsular nerve group block (PENG) in preventing positioning pain during spinal anesthesia in patients who are scheduled for surgery due to hip fracture.


Description:

Patients to whom an analgesic block was placed (either PENG or SIFI compartment analgesic block) to ameliorate positioning pain during spinal anesthesia for hip fracture surgery will be enrolled after written consent is obtained. Patients will be asked to report their pain intensity while sitting and their sitting angle will be measured. Patients will be observed for any possible complications( LAST, allergic reactions, hypotension, bradycardia). Pain intensity will then again be questioned postoperatively along with analgesic consumption at the 24th hour. Patients will be arranged into two cohorts according to the block (PENG vs SIFI) and the data obtained will be compared between two cohorts.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date January 20, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults with a hip fracture - who were scheduled to undergo surgery with spinal anesthetics - has no neurologic disorders that impair cooperation (e.g dementia) - has no true allergies to local anesthetics - has no contraindications for regional or neuraxial anesthesia (e.g bleeding diathesis, severe aortic stenosis) Exclusion Criteria: - Childer under the age of 18 - patients scheduled to undergo surgery with general anesthetics - refusing to participate - allergies to local anesthetics - any neurologic disorder that impairs patient cooperation - any contraindication to regional or neuraxial anesthetics

Study Design


Intervention

Other:
PENG Block
PENG block for analgesic purposes performed before hip surgery
SIFI compartment block
SIFI compartment block for analgesic purposes performed before hip surgery
Diagnostic Test:
Numeric Rating Scale
Self-reported pain intensity score between 0-10
Angle of sitting
Measurement of sitting angle in degrees with a protractor

Locations

Country Name City State
Turkey Prof. Dr. Cemil Tascioglu City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Positioning pain during spinal anesthesia with 10-point numeric rating scale (NRS) NRS is a self-reported pain scale where patient defines intensity of their pain on a scale of 0 to 10. Zero means the patient has no pain while ten means the patient is experiencing the worst pain possible 30 minutes after the block is placed
Secondary Sitting angle during positioning Angle of sitting in degrees measured with a protractor during sitting for spinal anesthesia 30 minutes after the block is placed
Secondary Postoperative pain with 10-point numeric rating scale (NRS) NRS is a self-reported pain scale where patient defines intensity of their pain on a scale of 0 to 10. Zero means the patient has no pain while ten means the patient is experiencing the worst pain possible Postoperative day 1
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