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Completed

NCT Number: NCT06795724

Effect of Peng Block Application on Inflammation and Mortality in Hip Fractures

In this study, the investigators the effect of PENG block on SIRI (systemic inflammation response index) and 30-day mortality in geriatric patients(over 65 years old) undergoing hip surgery, and the effect on the length of hospital stay.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

Patients over the age of 65 who were scheduled for surgery due to hip fracture were included in the study. According to the power analysis, it was estimated that at least 52 patients would be required for adequate statistical power. Initially, a total of 60 patients were assessed for eligibility and planned to be divided into two groups by randomization. Multimodal analgesia was applied to both groups.

The first group (Group P) received a preoperative Pericapsular Nerve Group (PENG) block, while the second group (Group C) did not receive an analgesic block and was given paracetamol and tramadol hydrochloride for analgesia. All patients received spinal anesthesia using 10 mg of hyperbaric bupivacaine.

Preoperatively, IL-6, CRP, and complete blood count (CBC) tests were performed on all patients, and these tests were repeated 4, 24, and 48 hours after the surgical stimulus. At the end of the operation, total blood loss, transfused blood products and their volumes, and operation time were recorded. Postoperatively, NRS pain scores, time to first analgesic requirement, length of hospital stay, and 30-day mortality were evaluated.

Post-Completion Study Flow

After completion of the study, a total of 60 patients were assessed for eligibility as planned. Of these, 2 patients declined to participate. The remaining 58 patients were randomized into two groups.

In Group P, one patient required conversion to general anesthesia during surgery. In Group C, two patients required intraoperative sedation, and one patient required conversion to general anesthesia. Therefore, four patients were excluded from the final analysis.

As a result, the analyses were conducted on 54 patients in total, with 28 patients in Group P and 26 patients in Group C.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-2-3 score
  • Hip Fracture Surgery

Exclusion criteria

  • Refusal to participate in the study
  • ASA score of 4 and above
  • Obesity (BMI >40)
  • Failure of spinal block
  • Switching to general anesthesia
  • Patients undergoing revision surgery
  • Patients with multitrauma
  • Patients with old fractures (>3 weeks)
  • Patients receiving preoperative and intraoperative sedation
  • Patients with active malignancy receiving RT, KT
  • Patients with active infection, patients receiving antibiotic treatment
  • Patients with contraindications for regional anesthesia techniques
  • Patients receiving chronic treatment with steroids or immunosuppressants
  • Patients using anti-inflammatory drugs

Treatment and study plan

PENG block

Other

For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 20cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.

Control

Other

Standard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol.

Primary outcomes

  1. SIRI-systemic inflammatory response index

    Time frame: Preoperative, Postsurgery 4. 24. 48.hour

    The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".

  2. IL-6

    Time frame: Preoperative, Postsurgery 4. 24. 48.hour

    Measurement of IL-6 level in blood

Secondary outcomes

  1. CRP

    Time frame: Preoperative, Postsurgery 4. 24. 48.hour

    Measurement of CRP level in blood

  2. SII

    Time frame: Preoperative, Postsurgery 4. 24. 48.hour

    systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"

  3. NLR

    Time frame: Preoperative, Postsurgery 4. 24. 48.hour

    neutrophil-to-lymphocyte ratio

  4. NRS score

    Time frame: Postoperative 0-2-8-16-24-36-48 hour

    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

  5. Additional analgesic requirement

    Time frame: Postoperative first 24 hour

    The time of first postoperative analgesic requirement will be noted.

  6. length of hospital stay

    Time frame: 1 week

    total day of hospital stay will be noted

  7. Mortality

    Time frame: Postoperative 30 day

    30-day mortality of patients will be followed.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Effect of PENG Block on Inflammatory Parameters and Mortality in Geriatric Patients Undergoing Hip Fracture Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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