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Postoperative AnalgesiaNCT07513740

PENG vs Deep Iliacus Plane Block in Intertrochanteric Femur Fractures

A study testing Intravenous Analgesia, Pericapsular nerve group (PENG) block and Deep Iliacus Plane Block (DIPB) in people with Postoperative Analgesia and Hip Surgery, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Intertrochanteric femur fractures are common in elderly patients and are associated with significant pain. Providing effective analgesia is clinically important both during positioning for spinal anesthesia and in the postoperative period in this patient population. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Postoperative Analgesia, Hip Surgery
What is being tested?
Intravenous Analgesia, Pericapsular nerve group (PENG) block and Deep Iliacus Plane Block (DIPB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2026to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for elective surgery for intertrochanteric femur fractures
  • Patients with ASA physical status I, II, or III
  • Patients aged between 30 and 85 years

Who cannot join

  • Patients with ASA physical status IV or higher
  • Patients undergoing emergency surgery
  • Patients who refuse to participate or withdraw consent during the study
  • Patients with cognitive dysfunction such as Alzheimer's disease, dementia, or delirium
  • Patients with a history of local anesthetic toxicity
  • Patients with infection at the planned block site
Show all 9Show fewer
  • Patients with bleeding diathesis
  • Patients undergoing additional surgical procedures or additional anesthesia (e.g., general anesthesia)
  • Patients with a history of chronic opioid use or receiving treatment for neuropathic pain

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Erzincan Mengücek Gazi Eğitim ve Araştırma Hastanesi

    Erzincan, Merkez/Türkiye, 24000

    Taha Emre ÖTÜGEN, +905307060125, tahaemreotugen@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Analgesic Efficacy of the PENG Block and the Deep Iliacus Plane Block During Positioning for Spinal Anesthesia and in the Postoperative Period in Intertrochanteric Femur Fractures: A Prospective, Randomized Controlled Study

Intertrochanteric femur fractures are common in elderly patients and are associated with significant pain. Providing effective analgesia is clinically important both during positioning for spinal anesthesia and in the postoperative period in this patient population.

The Pericapsular Nerve Group (PENG) block is a regional anesthesia technique that targets the articular branches of the hip capsule and may provide effective analgesia with motor-sparing potential. The Deep Iliacus Plane Block (DIPB) is a newer approach that may spread to both the articular branches and the lateral femoral cutaneous nerve.

Read more

Although both blocks are used in patients with intertrochanteric fractures, there is a lack of sufficient randomized controlled data comparing their effectiveness for pain during positioning for spinal anesthesia and for postoperative analgesia. Therefore, it is important to determine which technique provides greater clinical benefit.

The aim of this study is to compare the analgesic efficacy of the PENG block and the Deep Iliacus Plane Block during positioning for spinal anesthesia and in the postoperative period in patients undergoing surgery for intertrochanteric femur fractures.

Read the detailed description

This study was planned as a prospective, single-center, double-blind randomized controlled trial to be conducted in the operating room of Erzincan Mengücek Gazi Training and Research Hospital. The study will commence after obtaining approval from the institutional ethics committee and written informed consent from all patients.

A minimum of 75 patients aged between 18 and 75 years, classified as ASA physical status I, II, or III, who are scheduled for elective surgery under spinal anesthesia for intertrochanteric femur fractures by the Orthopedics and Traumatology Department, will be included in the study.

Patients with ASA IV or higher risk scores, those undergoing emergency surgery, those who refuse participation or wish to withdraw, patients with cognitive dysfunction such as Alzheimer's disease, dementia, or delirium, those with a history of local anesthetic toxicity, infection at the injection site, bleeding diathesis, those undergoing additional surgical or anesthetic procedures (e.g., general anesthesia), patients with chronic opioid use, and those receiving treatment for neuropathic pain will be excluded.

The study will be conducted over a 12-month period between March 1, 2026, and March 1, 2027. All patients will be informed about the study protocol and procedures one day prior to surgery, and written informed consent will be obtained.

Patients admitted to the preoperative preparation room will undergo routine monitoring and will be allocated into three groups according to the analgesic method applied before surgery:

Control group (Group C): intravenous analgesia only Group P: Pericapsular Nerve Group (PENG) block Group D: Deep Iliacus Plane Block (DIPB)

For patients receiving regional blocks, after ensuring sterile conditions, 30 mL of 0.25% bupivacaine will be injected into the appropriate plane under ultrasound guidance.

Patients will be randomized in a 1:1:1 ratio using a computer-generated variable block randomization method (block sizes of 6 and 9). Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE method). The randomization list will be prepared by an independent researcher not involved in the study, and envelopes will be opened in the preoperative room immediately before block administration.

All block procedures will be performed by the same anesthesiologist to ensure standardization. The practitioner performing the block will not be involved in intraoperative or postoperative assessments. Intraoperative management, monitoring, and postoperative pain assessments will be conducted by other anesthesiologists participating in the study. The study is designed as double-blind, with both patients and outcome assessors blinded to the type of block performed.

In the operating room, patients will be monitored, and standard hemodynamic parameters (SpO₂, blood pressure, heart rate) will be recorded throughout the perioperative period. Nasal oxygen at 2 L/min will be administered routinely.

At 30 minutes after block application, pain levels will be assessed using the Numerical Rating Scale (NRS). Due to pain and limited mobility associated with femur fractures, motor block will be evaluated using an isometric quadriceps contraction test that does not require joint movement. Patients will be asked, in the supine position, to press their knee downward against the bed ("quad set"), and quadriceps contraction will be assessed by palpation. Motor block will be recorded using a three-point scale:

0 = No contraction

  1. = Weak contraction (palpable but not producing significant force)
  2. = Normal contraction (strong and clearly palpable)

The Numerical Rating Scale (NRS) is a validated and widely used method in which patients rate their pain from 0 (no pain) to 10 (worst imaginable pain).

Sensory block will be assessed using a cold discrimination test, comparing both sides, and the presence of hypoesthesia or anesthesia at the dermatomal level will be recorded.

Patients will then be positioned in the sitting position for spinal anesthesia, and pain scores during positioning will be recorded. Spinal anesthesia will be performed at the L3-L4 interspace using a 25G pencil-point spinal needle in the sitting position, with administration of 15 mg (3 mL) of 0.5% hyperbaric bupivacaine and 20 mcg (0.4 mL) fentanyl. Surgery will commence after achieving a sensory block level of T10.

Postoperatively, patients will be transferred to the recovery unit as per routine practice. Patients with an Aldrete score >9 will be transferred to the ward. The Aldrete Scoring System evaluates physiological recovery after anesthesia based on five parameters: activity, respiration, circulation, consciousness, and oxygen saturation, each scored from 0 to 2, with a maximum total score of 10.

Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 3, 6, 12, and 24 hours and recorded. All patients will receive routine postoperative analgesia consisting of intravenous ibuprofen 400 mg twice daily.

Additionally, as per standard practice in the orthopedic ward, if the NRS score is ≥4, rescue analgesia will be administered as intravenous tramadol at a dose of 1 mg/kg. The interval between tramadol doses will be at least 6 hours, and the maximum daily dose will not exceed 400 mg.

Within the first 24 postoperative hours, the total amount and types of additional analgesics (NSAIDs or opioids) used for pain control will be recorded. Postoperative evaluations will be performed by physicians who are blinded to the type of block applied.

Being tested
Intravenous Analgesia, Pericapsular nerve group (PENG) block, Deep Iliacus Plane Block (DIPB)
Keywords
Deep İliacus Plane Block, Hip Surgery, PENG, Meta-PENG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous AnalgesiaDrug

    Standard preoperative intravenous analgesia according to institutional protocol.

  • Pericapsular nerve group (PENG) blockProcedure or surgery

    Ultrasound-guided PENG block with injection of 30 mL of 0.25% bupivacaine.

  • Deep Iliacus Plane Block (DIPB)Procedure or surgery

    Ultrasound-guided Deep Iliacus Plane Block with injection of 30 mL of 0.25% bupivacaine.

Study groups in NCT07513740
Study groupRoleWhat they receive
Control Group (Group C)Active comparatorPatients receive standard intravenous analgesia without any regional block before spinal anesthesia.
Receives: Drug: Intravenous Analgesia
PENG Block Group (Group P)ExperimentalPatients receive an ultrasound-guided Pericapsular Nerve Group (PENG) block before spinal anesthesia.
Receives: Procedure: Pericapsular nerve group (PENG) block
Deep Iliacus Plane Block Group (Group D)ExperimentalPatients receive an ultrasound-guided Deep Iliacus Plane Block before spinal anesthesia. Intervention:
Receives: Procedure: Deep Iliacus Plane Block (DIPB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain during positioning for spinal anesthesia

    Pain intensity during positioning for spinal anesthesia assessed using the Numerical Rating Scale (NRS, 0-10).

    Measured: During positioning (approximately 30 minutes after block)

Secondary outcomes (5)
  1. Postoperative pain scores

    Postoperative pain assessed using the Numerical Rating Scale

    Measured: 3, 6, 12, and 24 hours postoperatively

  2. Total analgesic consumption

    Total amount of rescue and routine analgesics used within 24 hours.

    Measured: First 24 postoperative hours

  3. Need for rescue analgesia

    Proportion of patients requiring rescue analgesia (NRS ≥4).

    Measured: First 24 postoperative hours

  4. Motor block assessment

    Motor block evaluated via isometric quadriceps contraction test.

    Measured: 30 minutes after block

  5. Sensory block distribution

    Sensory block assessed with cold discrimination test.

    Measured: 30 minutes after block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start1 Mar 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

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
Prospective, Single-center, Double-blind, Randomized controlled trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07513740
Sponsor's protocol ID
AnestheiologyTEO-01
Status last verified
Mar 2026
First submitted
31 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tulgar S, Ciftci B, Koyuncu B, Ahiskalioglu A, Alver S, Bilal B, Sakul BU, Otu E, Narayanan M, Alici HA. Ultrasound-guided Deep Iliacus Plane Block (DIPB): Cadaveric Evaluation and Pilot Retrospective Evaluation of Another Novel Fascial Plane Block for Hip Analgesia. Turk J Anaesthesiol Reanim. 2026 Feb 9;54(1):55-61. doi: 10.4274/TJAR.2025.252252. Epub 2026 Jan 7.

    PubMed 41498358
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PubMed 30063657
  • Maxwell BG, Spitz W, Porter J. Association of Increasing Use of Spinal Anesthesia in Hip Fracture Repair With Treating an Aging Patient Population. JAMA Surg. 2020 Feb 1;155(2):167-168. doi: 10.1001/jamasurg.2019.4471.

    PubMed 31746959

Questions about this trial

What is this clinical trial studying?

A study testing Intravenous Analgesia, Pericapsular nerve group (PENG) block and Deep Iliacus Plane Block (DIPB) in people with Postoperative Analgesia and Hip Surgery, run by Erzincan Binali Yildirim Universitesi 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 9 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Taha Emre ÖTÜGEN (+905307060125, tahaemreotugen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain during positioning for spinal anesthesia (time frame: During positioning (approximately 30 minutes after block)). 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 NCT07513740, which also lists 3 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 7 Apr 2026.

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