Clinical trial NCT06795724: Effect of Peng Block Application on Inflammation and Mortality in Hip Fractures
Official title: Effect of PENG Block on Inflammatory Parameters and Mortality in Geriatric Patients Undergoing Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Response
Anesthesia
Hip Fractures
Keywords: PENG block
inflammation
SIRI
Mortality
Hip fracture
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: SIRI-systemic inflammatory response index
timeFrame: Preoperative, Postsurgery 4. 24. 48.hour
measure: IL-6
timeFrame: Preoperative, Postsurgery 4. 24. 48.hour
Secondary outcomes:
measure: CRP
timeFrame: Preoperative, Postsurgery 4. 24. 48.hour
measure: SII
timeFrame: Preoperative, Postsurgery 4. 24. 48.hour
measure: NLR
timeFrame: Preoperative, Postsurgery 4. 24. 48.hour
measure: NRS score
timeFrame: Postoperative 0-2-8-16-24-36-48 hour
measure: Additional analgesic requirement
timeFrame: Postoperative first 24 hour
measure: length of hospital stay
timeFrame: 1 week
measure: Mortality
timeFrame: Postoperative 30 day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: burak nalbant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.