- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05549011
PENG vs SIFI Block for Positioning Pain During Spinal Anesthesia
March 6, 2023 updated by: Onur Okur, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Comparison of the Effect of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block for Preventing Positioning Pain During Spinal Anesthesia in Orthopedic Hip Surgery Patients: A Prospective Observational Study
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.
Study Overview
Status
Completed
Detailed 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.
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34384
- Prof. Dr. Cemil Taşcıoğlu City Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from a population of patients in a tertiary medical care center who are scheduled to undergo hip fracture surgery with spinal anesthetics and to whom either of the analgesic blocks PENG or SIFI compartment block is placed.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PENG block
This cohort will include participants to whom a PENG block is performed before positioning for spinal anesthesia
|
PENG block for analgesic purposes performed before hip surgery
Self-reported pain intensity score between 0-10
Measurement of sitting angle in degrees with a protractor
|
|
SIFI block
This cohort will include participants to whom a SIFI compartment block is performed before positioning for spinal anesthesia
|
Self-reported pain intensity score between 0-10
Measurement of sitting angle in degrees with a protractor
SIFI compartment block for analgesic purposes performed before hip surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positioning pain during spinal anesthesia with 10-point numeric rating scale (NRS)
Time Frame: 30 minutes after the block is placed
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sitting angle during positioning
Time Frame: 30 minutes after the block is placed
|
Angle of sitting in degrees measured with a protractor during sitting for spinal anesthesia
|
30 minutes after the block is placed
|
|
Postoperative pain with 10-point numeric rating scale (NRS)
Time Frame: Postoperative day 1
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Onur OKUR, Prof. Dr. Cemil Taşcıoğlu City Hospital
- Study Director: Müslüm AKKILIC, Prof. Dr. Cemil Taşcıoğlu City Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
September 17, 2022
First Submitted That Met QC Criteria
September 20, 2022
First Posted (Actual)
September 22, 2022
Study Record Updates
Last Update Posted (Estimate)
March 7, 2023
Last Update Submitted That Met QC Criteria
March 6, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 326
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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