- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795724
Effect of Peng Block Application on Inflammation and Mortality in Hip Fractures
Effect of PENG Block on Inflammatory Parameters and Mortality in Geriatric Patients Undergoing Hip Fracture Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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: Control
Standard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol.
|
Standard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SIRI-systemic inflammatory response index
Time Frame: Preoperative, Postsurgery 4. 24. 48.hour
|
The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".
|
Preoperative, Postsurgery 4. 24. 48.hour
|
|
IL-6
Time Frame: Preoperative, Postsurgery 4. 24. 48.hour
|
Measurement of IL-6 level in blood
|
Preoperative, Postsurgery 4. 24. 48.hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CRP
Time Frame: Preoperative, Postsurgery 4. 24. 48.hour
|
Measurement of CRP level in blood
|
Preoperative, Postsurgery 4. 24. 48.hour
|
|
SII
Time Frame: Preoperative, Postsurgery 4. 24. 48.hour
|
systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"
|
Preoperative, Postsurgery 4. 24. 48.hour
|
|
NLR
Time Frame: Preoperative, Postsurgery 4. 24. 48.hour
|
neutrophil-to-lymphocyte ratio
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Preoperative, Postsurgery 4. 24. 48.hour
|
|
NRS score
Time Frame: 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.
|
Postoperative 0-2-8-16-24-36-48 hour
|
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Additional analgesic requirement
Time Frame: Postoperative first 24 hour
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The time of first postoperative analgesic requirement will be noted.
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Postoperative first 24 hour
|
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length of hospital stay
Time Frame: 1 week
|
total day of hospital stay will be noted
|
1 week
|
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Mortality
Time Frame: Postoperative 30 day
|
30-day mortality of patients will be followed.
|
Postoperative 30 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: burak nalbant, Ankara City Hospital Bilkent
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-24-8891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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