- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06878963
COmparison of PENG Block and SIFICB in Hip Fracture Surgeries
Comparison of the Effects of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Neuraxial Anesthesia Positioning and Postoperative Analgesia in Hip Fracture Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hip fractures are a significant health problem that leads to severe morbidity and mortality in elderly individuals. Neuroaxial anesthesia is often preferred in the surgical treatment of these patients due to its ability to maintain hemodynamic stability and manage postoperative analgesia. However, the severe pain accompanying these fractures makes it difficult to achieve an appropriate position for neuroaxial anesthesia, which complicates both patient comfort and the work of the anesthesia provider.
In recent years, peripheral nerve blocks have emerged as an effective method to overcome this challenge. The pericapsular nerve group (PENG) block and supra-inguinal fascia iliaca compartment block (SIFIB) are commonly used techniques for the management of pain related to hip fractures. While studies comparing the analgesic efficacy of these two blocks exist in the literature, data regarding their specific effects on neuroaxial anesthesia positioning are limited.
In this study, patients scheduled for surgery due to hip fractures will receive either a pericapsular nerve group (PENG) block or a supra-inguinal fascia iliaca compartment block (SIFIB). Both block procedures will be performed under ultrasound guidance and sterile conditions, following standard protocols. After the block procedure, the time taken for patients to transition into the neuroaxial anesthesia position (primary outcome) will be measured, and the level of pain experienced during positioning will be assessed using the Visual Analog Scale (VAS).
In the postoperative period, VAS scores and additional analgesic requirements (secondary outcomes) will be recorded for 24 hours. Demographic data (age, gender, body mass index) and comorbidities will also be collected and used for intergroup comparisons. Throughout the study, patient privacy will be respected, and the collected data will be analyzed anonymously.
The study will be conducted in accordance with the Declaration of Helsinki, and informed consent will be obtained from all participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hip fractures
- 40-80 years
Exclusion Criteria:
- Contraindicated to spinal anesthesia
- allergy to local anesthetics
- severe peripheral neuropathy
- mental disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group P
The PENG block will be performed on the patient with the injection of local anesthesia under ultrasound guidance in the femoral region, beneath the biceps tendon.
|
The PENG block will be performed on the patient with the injection of local anesthesia under ultrasound guidance in the femoral region, beneath the biceps tendon.
|
|
Experimental: Group S
The SIFIB block will be performed on the patient with the injection of local anesthetic between the iliac fascia and iliac muscle in the femoral region, under ultrasound guidance.
|
The SIFIB block will be performed on the patient with the injection of local anesthetic between the iliac fascia and iliac muscle in the femoral region, under ultrasound guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient positioning
Time Frame: During neuroaxial block procedure
|
In patients with hip fractures, during spinal anesthesia, the angle between the patient's back and the operating table will be recorded while positioning the patient.
|
During neuroaxial block procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) score
Time Frame: During neuroaxial block procedure
|
VAS score is a measurement instrument for subjective characteristics of pain.
VAS score range from 0 to 10. 0 refers to no pain and 10 refers to the worst pain ever had
|
During neuroaxial block procedure
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADYU-ANS-NY-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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