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

A

Ankara City Hospital

Status

Completed

Conditions

Hip Fractures
Inflammatory Response
Anesthesia

Treatments

Other: PENG block
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT06795724
E2-24-8891

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

PENG Block
Active Comparator group
Description:
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.
Treatment:
Other: PENG block
Control
Other group
Description:
Standard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol.
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

burak nalbant

Data sourced from clinicaltrials.gov

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