Collum Femoris FractureNCT06277648
the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients
A study testing PENG block and SIFIB in people with Collum Femoris Fracture and Pericapsular Nerve Group Block, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures. The participants will be patients determined to have proximal femoral nailing. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Collum Femoris Fracture, Pericapsular Nerve Group Block, Suprainguinal Fascia Iliaca Block
- What is being tested?
- PENG block and SIFIB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 15 Jun 2024
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 65
- Patients scheduled for proximal femoral nailing
- Patients with American Society of Anesthesiologists (ASA) Physical Status classification of I to IV.
Who cannot join
- refusal to participate
- a history of neurological deficits or neuropathy
- infection at the site of block application
- coagulopathy
- allergy to local anaesthetics
- patients with severe cardiopulmonary insufficiency or renal impairment
- mental illness.
- prolonged surgery due to orthopaedic complications of more than 3 hours, necessitating conversion of spinal anaesthesia to general anaesthesia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi
About this study
Official title: Comparison of the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients With Subtrochanteric Femur Fractures
This clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures.
The participants will be patients determined to have proximal femoral nailing. According to randomisation, each participant will receive either PENG or SIFIB postoperatively after spinal anaesthesia. The investigator will measure postoperative pain scores, total amount of analgesic consumption and motor ability postoperatively.
Read the detailed description
Randomization and blindness Randomization was designed as 3 (n= 25) named Groups A, B, and C in a 1:1:1 ratio with a computer-based algorithm and sealed in opaque envelopes by the surgeon assigned to the study. The investigator anesthesiologist selected an envelope in order of numbers written on it and proceeded with PENG if it was Group A and SIFIB if it was Group B. There was no other intervention than intravenous analgesia if it was Group C. The orthopaedic surgeon responsible for the study was blinded to the study groups. This surgeon was the sole evaluator of postoperative pain scores and total analgesia consumption. All block procedures were performed by the primary investigator (B.C.) The duration of block performance and number of needle manipulations before local anaesthetic injections were recorded by the anaesthesia technician assisting the procedure.
Anaesthesia, interventions, and post-interventional follow-up Standardization All patients received standard spinal anaesthesia procedures with 10 mg of heavy Marcaine (2 mL of bupivacaine 0.5%) and 20 µg of fentanyl (0.5 ml) at L3-4 intervertebral space with the aid of midazolam 0.02 mg /kg and ketamine 0.3 mg/kg to-analgesia to achieve sitting position. According to randomization, patients in the study groups (Group PENG and SIFIB) received block procedures with the same local anaesthetic mixture as 30 mL 0.375% bupivacaine postoperatively in the recovery room under monitorization. The same analgesia plan was ordered for all participants as paracetamol 1 gr (four times daily), tenoxicam 20 mg (daily) and dexamethasone 8 mg once postoperatively. They received rescue analgesia only if they had persistent pain scores higher than 4 of 10 or asked for analgesia, as 1mg/kg tramadol (maximum daily dose, 4x1).
Interventions; block procedures PENG block was performed by the primary investigator (B.C) following proper skin disinfection with the patient in the supine position. Under the guidance of a low-frequency curvilinear ultrasound probe, the iliopubic eminence and the psoas tendon were identified, and local anaesthetic was injected between the periosteum and psoas tendon following negative aspiration.
For SIFIB, the high-frequency linear probe was placed medial to the anterosuperior iliac spine in a parasagittal orientation to visualize the bow tie appearance formed by the sartorius internal oblique and iliacus muscle. The needle tip was placed under fascia iliaca through an in-plane approach, and local anaesthetic was injected from the caudad to the cephalic direction.
Outcome Measures Primary outcome The primary outcome of this study is the pain scores. They were assessed by the same orthopaedic surgeon using the NRS (which ranges from 0 to 10, where zero represents the absence of pain, and 10 signifies the worst imaginable pain) at postoperative intervals of 0,4, 8, 12, and 24 hours.
Secondary outcomes The blinded orthopaedic surgeon recorded the number of times rescue analgesia was applied within 24 hours postoperatively as analgesic consumption. Also, block performances were compared by the duration of interventions and the presence of motor block as hip adduction at the postoperative 6th hour.
Sample size and statistical analysis The sample size was based on detecting a change of 2 units or more in mean pain scores (the primary outcome) using analysis of covariance on the outcomes at the follow-up time point. Using an estimated standard deviation of 2 units for pain scores (0-10) with standard type I and type II error rates, we calculated that 20 patients per group would be needed. To allow dropouts or exclusions, we enrolled 25 patients on each group to have a total sample size of 75 participants.
- Conditions
- Collum Femoris Fracture, Pericapsular Nerve Group Block, Suprainguinal Fascia Iliaca Block
- Being tested
- PENG block, SIFIB
- Keywords
- femur fracture, suprainguinal fascia iliaca block, pericapsular nerve group block, elderly patients, postoperative pain
- Medical subject headings
- Femoral Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG blockProcedure or surgery
Also called pericapsuşar nerve group block
PENG block was performed by the primary investigator (B.C) following proper skin disinfection with the patient in the supine position. Under the guidance of a low-frequency curvilinear ultrasound probe, the iliopubic eminence and the psoas tendon were identified, and local anaesthetic as 30 mL 0.375% bupivacaine was injected between the periosteum and psoas tendon following negative aspiration.
SIFIBProcedure or surgery
Also called suprainguinal fascia iliaca block
The high-frequency linear probe was placed medial to the anterosuperior iliac spine in a parasagittal orientation to visualize the bow tie appearance formed by the sartorius's internal oblique and iliacus muscles. The needle tip was placed under fascia iliaca through an in-plane approach, and local anaesthetic as 30 mL 0.375% bupivacaine was injected from the caudad to the cephalic direction.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | All patients received standard spinal anaesthesia procedures with multimodal pain protocol postoperatively. |
| PENG block | Experimental | All patients received standard spinal anaesthesia procedures with PENG block postoperatively. Receives: Procedure: PENG block |
| SIFI block | Experimental | All patients received standard spinal anaesthesia procedures with SIFIB postoperatively. Receives: Procedure: SIFIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
the numeric rating scale (which ranges from 0 to 10, where zero represents the absence of pain, and 10 signifies the worst imaginable pain)
Measured: postoperative 24 hour
Secondary outcomes (1)
rescue analgesia
The number of times rescue analgesia was applied
Measured: postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2022
- Primary completion1 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Collum Femoris FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a double-blind, prospective, randomized, controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, Principal investigator, Haseki Training and Research Hospital Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277648
- Sponsor's protocol ID
- 18-2021
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2024
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vamshi C, Sinha C, Kumar A, Kumar A, Kumari P, Kumar A, Kumar S, Arun SK. Comparison of the efficacy of pericapsular nerve group block (PENG) block versus suprainguinal fascia iliaca block (SFIB) in total hip arthroplasty: A randomized control trial. Indian J Anaesth. 2023 Apr;67(4):364-369. doi: 10.4103/ija.ija_311_22. Epub 2023 Apr 10.
PubMed 37303868Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
PubMed 34290085
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients With Subtrochanteric Femur Fractures
- ClinicalTrials.gov ID
- NCT06277648
- Acronym / sponsor ID
- 18-2021
- Conditions
- Collum Femoris Fracture, Pericapsular Nerve Group Block, Suprainguinal Fascia Iliaca Block
- Keywords
- femur fracture, suprainguinal fascia iliaca block, pericapsular nerve group block, elderly patients, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 26 Feb 2024 (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 clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures.
The participants will be patients determined to have proximal femoral nailing. According to randomisation, each participant will receive either PENG or SIFIB postoperatively after spinal anaesthesia. The investigator will measure postoperative pain scores, total amount of analgesic consumption and motor ability postoperatively.
Detailed description
Randomization and blindness Randomization was designed as 3 (n= 25) named Groups A, B, and C in a 1:1:1 ratio with a computer-based algorithm and sealed in opaque envelopes by the surgeon assigned to the study. The investigator anesthesiologist selected an envelope in order of numbers written on it and proceeded with PENG if it was Group A and SIFIB if it was Group B. There was no other intervention than intravenous analgesia if it was Group C. The orthopaedic surgeon responsible for the study was blinded to the study groups. This surgeon was the sole evaluator of postoperative pain scores and total analgesia consumption. All block procedures were performed by the primary investigator (B.C.) The duration of block performance and number of needle manipulations before local anaesthetic injections were recorded by the anaesthesia technician assisting the procedure.
Anaesthesia, interventions, and post-interventional follow-up Standardization All patients received standard spinal anaesthesia procedures with 10 mg of heavy Marcaine (2 mL of bupivacaine 0.5%) and 20 µg of fentanyl (0.5 ml) at L3-4 intervertebral space with the aid of midazolam 0.02 mg /kg and ketamine 0.3 mg/kg to-analgesia to achieve sitting position. According to randomization, patients in the study groups (Group PENG and SIFIB) received block procedures with the same local anaesthetic mixture as 30 mL 0.375% bupivacaine postoperatively in the recovery room under monitorization. The same analgesia plan was ordered for all participants as paracetamol 1 gr (four times daily), tenoxicam 20 mg (daily) and dexamethasone 8 mg once postoperatively. They received rescue analgesia only if they had persistent pain scores higher than 4 of 10 or asked for analgesia, as 1mg/kg tramadol (maximum daily dose, 4x1).
Interventions; block procedures PENG block was performed by the primary investigator (B.C) following proper skin disinfection with the patient in the supine position. Under the guidance of a low-frequency curvilinear ultrasound probe, the iliopubic eminence and the psoas tendon were identified, and local anaesthetic was injected between the periosteum and psoas tendon following negative aspiration.
For SIFIB, the high-frequency linear probe was placed medial to the anterosuperior iliac spine in a parasagittal orientation to visualize the bow tie appearance formed by the sartorius internal oblique and iliacus muscle. The needle tip was placed under fascia iliaca through an in-plane approach, and local anaesthetic was injected from the caudad to the cephalic direction.
Outcome Measures Primary outcome The primary outcome of this study is the pain scores. They were assessed by the same orthopaedic surgeon using the NRS (which ranges from 0 to 10, where zero represents the absence of pain, and 10 signifies the worst imaginable pain) at postoperative intervals of 0,4, 8, 12, and 24 hours.
Secondary outcomes The blinded orthopaedic surgeon recorded the number of times rescue analgesia was applied within 24 hours postoperatively as analgesic consumption. Also, block performances were compared by the duration of interventions and the presence of motor block as hip adduction at the postoperative 6th hour.
Sample size and statistical analysis The sample size was based on detecting a change of 2 units or more in mean pain scores (the primary outcome) using analysis of covariance on the outcomes at the follow-up time point. Using an estimated standard deviation of 2 units for pain scores (0-10) with standard type I and type II error rates, we calculated that 20 patients per group would be needed. To allow dropouts or exclusions, we enrolled 25 patients on each group to have a total sample size of 75 participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- a double-blind, prospective, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –All patients received standard spinal anaesthesia procedures with multimodal pain protocol postoperatively. |
| PENG block | Experimental | Procedure: PENG blockAll patients received standard spinal anaesthesia procedures with PENG block postoperatively. |
| SIFI block | Experimental | Procedure: SIFIBAll patients received standard spinal anaesthesia procedures with SIFIB postoperatively. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 65
- Patients scheduled for proximal femoral nailing
- Patients with American Society of Anesthesiologists (ASA) Physical Status classification of I to IV.
Key exclusion criteria (8 listed)
- refusal to participate
- a history of neurological deficits or neuropathy
- infection at the site of block application
- coagulopathy
- allergy to local anaesthetics
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 blockAlso: pericapsuşar nerve group blockPENG block was performed by the primary investigator (B.C) following proper skin disinfection with the patient in the supine position. Under the guidance of a low-frequency curvilinear ultrasound probe, the iliopubic eminence and the psoas tendon were identified, and local anaesthetic as 30 mL 0.375% bupivacaine was injected between the periosteum and psoas tendon following negative aspiration. | Procedure or surgery | PENG block |
| SIFIBAlso: suprainguinal fascia iliaca blockThe high-frequency linear probe was placed medial to the anterosuperior iliac spine in a parasagittal orientation to visualize the bow tie appearance formed by the sartorius's internal oblique and iliacus muscles. The needle tip was placed under fascia iliaca through an in-plane approach, and local anaesthetic as 30 mL 0.375% bupivacaine was injected from the caudad to the cephalic direction. | Procedure or surgery | SIFI block |
Primary outcome
pain scores
Time frame: postoperative 24 hour
the numeric rating scale (which ranges from 0 to 10, where zero represents the absence of pain, and 10 signifies the worst imaginable pain)
1 secondary outcome
rescue analgesia
Time frame: postoperative 24 hour
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 20 Apr 2025.
- Background: PubMed 37303868Vamshi C, Sinha C, Kumar A, Kumar A, Kumari P, Kumar A, Kumar S, Arun SK. Comparison of the efficacy of pericapsular nerve group block (PENG) block versus suprainguinal fascia iliaca block (SFIB) in total hip arthroplasty: A randomized control trial. Indian J Anaesth. 2023 Apr;67(4):364-369. doi: 10.4103/ija.ija_311_22. Epub 2023 Apr 10.
- Background: PubMed 34290085Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
- Individual participant dataSharing planned: No
Related trials for Collum Femoris Fracture
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
Recruiting
MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)
Femoral Neck Fractures
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.
Berna Caliskan principal investigator
Haseki Training and Research Hospital Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block and SIFIB in people with Collum Femoris Fracture and Pericapsular Nerve Group Block, run by Haseki Training and Research Hospital 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 3 inclusion and 8 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 20 Apr 2025. 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?
pain scores (time frame: postoperative 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06277648, which also lists 2 linked publications.
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 20 Apr 2025.