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

Not Applicable

Recruiting

• Conditions: Anesthesia; Inflammatory Response; Hip Fractures

• Registration Number: NCT06795724
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Patients over the age of 65 who are scheduled for surgery due to hip fracture will be included in the study. According to the power analysis, a total of 60 patients will be included in the study. Patients will be divided into 2 groups by randomization.Multimodal analgesia will be applied to both groups. The first group will receive preoperative PENG block and the other group will not receive an analgesic block and will receive paracetamol and tramadol hydrochloride analgesia. All patients received spinal anesthesia using 10 mg bupivacaine. Preoperatively, IL-6, CRP, and hemogram tests will be performed on all patients and then these tests will be repeated 4, 24, and 48 hours after the surgical stimulus.

At the end of the operation, total bleeding amounts, blood products and amounts given, and operation time will be recorded. Postoperatively, NRS scores, initial analgesic requirements, hospital stays, and 30-day mortality will be monitored.

Study Timeline

• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-26
• Study First Posted: 2025-01-28
• Study Start: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SIRI-systemic inflammatory response index	Preoperative, Postsurgery 4. 24. 48.hour	The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".
IL-6	Preoperative, Postsurgery 4. 24. 48.hour	Measurement of IL-6 level in blood

Secondary Outcome Measures

Name	Time	Method
CRP	Preoperative, Postsurgery 4. 24. 48.hour	Measurement of CRP level in blood
SII	Preoperative, Postsurgery 4. 24. 48.hour	systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"
NLR	Preoperative, Postsurgery 4. 24. 48.hour	neutrophil-to-lymphocyte ratio
NRS score	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.
Additional analgesic requirement	Postoperative first 24 hour	The time of first postoperative analgesic requirement will be noted.
length of hospital stay	1 week	total day of hospital stay will be noted
Mortality	Postoperative 30 day	30-day mortality of patients will be followed.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey