NCT06795724

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

January 16, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

PENG blockinflammationSIRIMortalityHip fracture

Outcome Measures

Primary Outcomes (2)

  • SIRI-systemic inflammatory response index

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

    Preoperative, Postsurgery 4. 24. 48.hour

  • IL-6

    Measurement of IL-6 level in blood

    Preoperative, Postsurgery 4. 24. 48.hour

Secondary Outcomes (7)

  • CRP

    Preoperative, Postsurgery 4. 24. 48.hour

  • SII

    Preoperative, Postsurgery 4. 24. 48.hour

  • NLR

    Preoperative, Postsurgery 4. 24. 48.hour

  • NRS score

    Postoperative 0-2-8-16-24-36-48 hour

  • Additional analgesic requirement

    Postoperative first 24 hour

  • +2 more secondary outcomes

Study Arms (2)

PENG Block

ACTIVE COMPARATOR

PENG block will be performed before the surgery. 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.

Other: PENG block

Control

OTHER

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

Other: Control

Interventions

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.

PENG Block
ControlOTHER

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

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Fang Z, Gao B, Wang Z, Chen X, Liu M. Association of systemic inflammation response index with mortality risk in older patients with hip fracture: a 10-year retrospective cohort study. Front Med (Lausanne). 2024 May 22;11:1401443. doi: 10.3389/fmed.2024.1401443. eCollection 2024.

    PMID: 38841577BACKGROUND
  • Gentili ME, Mazoit JX, Samii K K, Fletcher D. The effect of a sciatic nerve block on the development of inflammation in carrageenan injected rats. Anesth Analg. 1999 Oct;89(4):979-84. doi: 10.1097/00000539-199910000-00029.

    PMID: 10512275BACKGROUND

MeSH Terms

Conditions

Hip FracturesInflammation

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • burak nalbant

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 28, 2025

Study Start

January 30, 2025

Primary Completion

July 17, 2025

Study Completion

August 17, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations