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

NCT ID: NCT06795724

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-08-17

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 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.

Conditions

Inflammatory Response; Anesthesia; Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

PENG Block

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.

Group Type: ACTIVE_COMPARATOR

PENG block

Intervention Type: 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

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

Group Type: OTHER

Control

Intervention Type: OTHER

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

Interventions

PENG block

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Burak NALBANT

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

burak nalbant

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 38841577 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10512275 (View on PubMed)

Other Identifiers

E2-24-8891

Identifier Type: -

Identifier Source: org_study_id