Inflammatory ResponseNCT06795724
Effect of Peng Block Application on Inflammation and Mortality in Hip Fractures
A study testing PENG block in people with Inflammatory Response and Anesthesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Inflammatory Response, Anesthesia, Hip Fractures
- What is being tested?
- PENG block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 17 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ASA 1-2-3 score
- Hip Fracture Surgery
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of PENG Block on Inflammatory Parameters and Mortality in Geriatric Patients Undergoing Hip Fracture Surgery
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.
Read the 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
- Being tested
- PENG block, Control
- Keywords
- PENG block, inflammation, SIRI, Mortality, Hip fracture
- Medical subject headings
- Hip Fractures, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG blockOther
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.
ControlOther
Standard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block | Active comparator | 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. Receives: Other: PENG block |
| Control | Other | Standard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRI-systemic inflammatory response index
The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".
Measured: Preoperative, Postsurgery 4. 24. 48.hour
IL-6
Measurement of IL-6 level in blood
Measured: Preoperative, Postsurgery 4. 24. 48.hour
Secondary outcomes (7)
CRP
Measurement of CRP level in blood
Measured: Preoperative, Postsurgery 4. 24. 48.hour
SII
systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"
Measured: Preoperative, Postsurgery 4. 24. 48.hour
NLR
neutrophil-to-lymphocyte ratio
Measured: Preoperative, Postsurgery 4. 24. 48.hour
NRS score
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.
Measured: Postoperative 0-2-8-16-24-36-48 hour
Additional analgesic requirement
The time of first postoperative analgesic requirement will be noted.
Measured: Postoperative first 24 hour
length of hospital stay
total day of hospital stay will be noted
Measured: 1 week
Mortality
30-day mortality of patients will be followed.
Measured: Postoperative 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start30 Jan 2025
- Primary completion17 Jul 2025
- Study completion17 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak NALBANT, Ankara City Hospital Bilkent
- Investigators
- burak nalbant, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795724
- Sponsor's protocol ID
- E2-24-8891
- Status last verified
- Nov 2025
- First submitted
- 16 Jan 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38841577Gentili 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.
PubMed 10512275
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PENG Block on Inflammatory Parameters and Mortality in Geriatric Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT06795724
- Acronym / sponsor ID
- E2-24-8891
- Conditions
- Inflammatory Response, Anesthesia, Hip Fractures
- Keywords
- PENG block, inflammation, SIRI, Mortality, Hip fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Aug 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG Block | Active comparator | Other: PENG blockPENG 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. |
| Control | Other | Other: ControlStandard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ASA 1-2-3 score
- Hip Fracture Surgery
Key exclusion criteria (14 listed)
- Refusal to participate in the study
- ASA score of 4 and above
- Obesity (BMI >40)
- Failure of spinal block
- Switching to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG blockFor 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 | PENG Block |
| ControlStandard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol. | Other | Control |
Primary outcome
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".
IL-6
Time frame: Preoperative, Postsurgery 4. 24. 48.hour
Measurement of IL-6 level in blood
7 secondary outcomes
CRP
Time frame: Preoperative, Postsurgery 4. 24. 48.hour
SII
Time frame: Preoperative, Postsurgery 4. 24. 48.hour
NLR
Time frame: Preoperative, Postsurgery 4. 24. 48.hour
NRS score
Time frame: Postoperative 0-2-8-16-24-36-48 hour
Additional analgesic requirement
Time frame: Postoperative first 24 hour
length of hospital stay
Time frame: 1 week
Mortality
Time frame: Postoperative 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 38841577Fang 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.
- Background: PubMed 10512275Gentili 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
burak nalbant principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block in people with Inflammatory Response and Anesthesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRI-systemic inflammatory response index (time frame: Preoperative, Postsurgery 4. 24. 48.hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.