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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06277648
Study groupRoleWhat they receive
ControlNo interventionAll patients received standard spinal anaesthesia procedures with multimodal pain protocol postoperatively.
PENG blockExperimentalAll patients received standard spinal anaesthesia procedures with PENG block postoperatively.
Receives: Procedure: PENG block
SIFI blockExperimentalAll 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.

  1. 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)
  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.

  1. First posted26 Feb 2024
  2. Study start1 Jan 2022
  3. Primary completion1 Jun 2024
  4. Study completion15 Jun 2024

Resources

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)
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 37303868
  • Aliste 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

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.

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