Hip FracturesNCT05549011
PENG vs SIFI Block for Positioning Pain During Spinal Anesthesia
An observational study of Hip Fractures and Acute Post Operative Pain, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Acute Post Operative Pain, Nerve Block
- What is being tested?
- PENG Block, SIFI compartment block and Numeric Rating Scale
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, 34384
About this study
Official title: 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.
Read the 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.
- Being tested
- PENG Block, SIFI compartment block, Numeric Rating Scale, Angle of sitting
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockOther
PENG block for analgesic purposes performed before hip surgery
SIFI compartment blockOther
SIFI compartment block for analgesic purposes performed before hip surgery
Numeric Rating ScaleDiagnostic test
Self-reported pain intensity score between 0-10
Angle of sittingDiagnostic test
Measurement of sitting angle in degrees with a protractor
| Study group | Role | What they receive |
|---|---|---|
| PENG block | This cohort will include participants to whom a PENG block is performed before positioning for spinal anesthesia Receives: Other: PENG Block; Diagnostic Test: Numeric Rating Scale; Diagnostic Test: Angle of sitting | |
| SIFI block | This cohort will include participants to whom a SIFI compartment block is performed before positioning for spinal anesthesia Receives: Other: SIFI compartment block; Diagnostic Test: Numeric Rating Scale; Diagnostic Test: Angle of sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes after the block is placed
Secondary outcomes (2)
Sitting angle during positioning
Angle of sitting in degrees measured with a protractor during sitting for spinal anesthesia
Measured: 30 minutes after the block is placed
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
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start20 Sep 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Okur, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Onur OKUR, Principal investigator, Prof. Dr. Cemil Taşcıoğlu City HospitalMüslüm AKKILIC, Study director, Prof. Dr. Cemil Taşcıoğlu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549011
- Sponsor's protocol ID
- 326
- Status last verified
- Mar 2023
- First submitted
- 17 Sep 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05549011
- Acronym / sponsor ID
- 326
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG block | – | Other: PENG Block, Diagnostic Test: Numeric Rating Scale, Diagnostic Test: Angle of sittingThis cohort will include participants to whom a PENG block is performed before positioning for spinal anesthesia |
| SIFI block | – | Other: SIFI compartment block, Diagnostic Test: Numeric Rating Scale, Diagnostic Test: Angle of sittingThis cohort will include participants to whom a SIFI compartment block is performed before positioning for spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG BlockPENG block for analgesic purposes performed before hip surgery | Other | PENG block |
| SIFI compartment blockSIFI compartment block for analgesic purposes performed before hip surgery | Other | SIFI block |
| Numeric Rating ScaleSelf-reported pain intensity score between 0-10 | Diagnostic test | PENG block, SIFI block |
| Angle of sittingMeasurement of sitting angle in degrees with a protractor | Diagnostic test | PENG block, SIFI block |
Primary outcome
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
2 secondary outcomes
Sitting angle during positioning
Time frame: 30 minutes after the block is placed
Postoperative pain with 10-point numeric rating scale (NRS)
Time frame: Postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur OKUR principal investigator
Prof. Dr. Cemil Taşcıoğlu City Hospital
Müslüm AKKILIC study director
Prof. Dr. Cemil Taşcıoğlu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Acute Post Operative Pain, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positioning pain during spinal anesthesia with 10-point numeric rating scale (NRS) (time frame: 30 minutes after the block is placed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.