ClinicalTrials.gg
RecruitingNCT07513740Updated Apr 7, 2026

PENG vs Deep Iliacus Plane Block in Intertrochanteric Femur Fractures

An interventional study of Intravenous Analgesia and Pericapsular nerve group (PENG) block in Postoperative Analgesia and Hip Surgery, sponsored by Erzincan Binali Yildirim Universitesi. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Erzincan Binali Yildirim Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Postoperative Analgesia
  • Hip Surgery

Keywords

  • Deep İliacus Plane Block
  • Hip Surgery
  • PENG
  • Meta-PENG
03

In context

Lead sponsor

Erzincan Binali Yildirim Universitesi is the lead sponsor of 23 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with 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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    Control Group (Group C)

    Patients receive standard intravenous analgesia without any regional block before spinal anesthesia.

    Drug: Intravenous Analgesia

  • Experimental
    PENG Block Group (Group P)

    Patients receive an ultrasound-guided Pericapsular Nerve Group (PENG) block before spinal anesthesia.

    Procedure: Pericapsular nerve group (PENG) block

  • Experimental
    Deep Iliacus Plane Block Group (Group D)

    Patients receive an ultrasound-guided Deep Iliacus Plane Block before spinal anesthesia. Intervention:

    Procedure: Deep Iliacus Plane Block (DIPB)

Interventions

  • DrugIntravenous Analgesia

    Standard preoperative intravenous analgesia according to institutional protocol.

  • ProcedurePericapsular nerve group (PENG) block

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

  • ProcedureDeep Iliacus Plane Block (DIPB)

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

06

What researchers measure

Primary outcomes

  1. Pain during positioning for spinal anesthesia

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

    Time frame: During positioning (approximately 30 minutes after block)

Secondary outcomes

  1. Postoperative pain scores

    Postoperative pain assessed using the Numerical Rating Scale

    Time frame: 3, 6, 12, and 24 hours postoperatively

  2. Total analgesic consumption

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

    Time frame: First 24 postoperative hours

  3. Need for rescue analgesia

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

    Time frame: First 24 postoperative hours

  4. Motor block assessment

    Motor block evaluated via isometric quadriceps contraction test.

    Time frame: 30 minutes after block

  5. Sensory block distribution

    Sensory block assessed with cold discrimination test.

    Time frame: 30 minutes after block

07

Study locations

1 of 1 sites recruiting
  • Erzincan Mengücek Gazi Eğitim ve Araştırma Hastanesi
    Erzincan, Merkez/Türkiye 24000, Turkey (Türkiye)
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07513740
Lead sponsor
Erzincan Binali Yildirim Universitesi
Responsible party
Taha Emre Ötügen (Anesthesiology specialist doctor, Erzincan Binali Yildirim Universitesi) — Principal investigator
First posted
Apr 7, 2026
Start date
Mar 1, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Apr 7, 2026

Study contacts

Taha Emre ÖTÜGEN
Contact
tahaemreotugen@gmail.com
+905307060125
Fethi AKYOL
Contact
fethi24@windowslive.com
+905055422992

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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