Femur FracturesNCT06604806
Comparison of Quadroiliac Plane Block and Pericapsular Nerve Group (PENG) Block in Femoral Fractures
A study testing PENG Block and Quadro-Iliac plane block in people with Femur Fractures, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, multicenter study will compare the postoperative analgesic efficacy of the Quadroiliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) block in patients undergoing femoral neck fracture surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fractures
- What is being tested?
- PENG Block and Quadro-Iliac plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 15 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients and their relatives have provided informed consent,
- Patients aged 18 years or older undergoing femoral fracture surgery,
- ASA score of I-III,
- No history of bleeding diathesis,
- No history of anticoagulant use that contraindicates block application according to guidelines,
- No history of neuropathic diseases such as Diabetes Mellitus,
- No known allergy to local anesthetics.
Who cannot join
- Lack of informed consent from the patient or their relatives,
- Development of complications during the surgical procedure,
- Need for revision surgery,
- Patient\'s desire to withdraw from the study,
- Patients under the age of 18,
- ASA score of IV or higher,
Show all 12Show fewer
- Patients with a history of bleeding diathesis,
- History of anticoagulant use that contraindicates block application according to guidelines,
- Emergency surgeries,
- History of allergy to local anesthetics,
- History of neuropathic diseases,
- Inability to comply with patient-controlled analgesia (PCA) systems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, 34303
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Quadroiliac Plane Block and Pericapsular Nerve Group (PENG) Block in Femoral Fractures: A Multicenter Randomized Controlled Prospective Study
This prospective, multicenter study will compare the postoperative analgesic efficacy of the Quadroiliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) block in patients undergoing femoral neck fracture surgery. Eligible patients will be randomly assigned to receive one of the blocks postoperatively under spinal anesthesia. The blocks will be administered by experienced anesthesiologists, and informed consent will be obtained from all participants.
Pain levels will be assessed using the visual analog scale (VAS) at rest and during movement at 0, 6, 12, and 24 hours post-surgery. Opioid consumption will be recorded through patient-controlled analgesia (PCA), and any need for rescue analgesia will be evaluated. Routine postoperative pain management will also include intravenous paracetamol.
Read the detailed description
This prospective, multicenter, observational study will be conducted at Başakşehir Çam and Sakura City Hospital and Kanuni Sultan Süleyman Training and Research Hospital. The study will include patients aged 18 and older, with an ASA score of I-II-III, undergoing femoral neck fracture surgery under spinal anesthesia. Patients with no history of bleeding diathesis, anticoagulant use, or allergies to the drugs used in the study, and without neuropathic diseases such as diabetes mellitus, will be randomly assigned to receive either the Pericapsular Nerve Group (PENG) block or the Quadroiliac Plane Block (QIPB) postoperatively.
Informed consent will be obtained from all patients, and detailed explanations of both blocks will be provided. Randomization will be performed using a computer program, assigning patients to either block method. Sealed envelopes will be provided to the anesthesiologists, who will apply the block indicated in the envelope at the end of surgery. Both blocks will be performed by experienced anesthesiologists, and only patients operated on under spinal anesthesia will be included in the study.
PENG Block Procedure:
With the patient in the supine position, the ultrasound probe is placed transversely over the anterior superior iliac spine (ASIS). After identifying the ASIS, the transducer is aligned with the pubic ramus and rotated approximately 45 degrees to become parallel to the inguinal crease. The transducer is moved medially until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and psoas tendon are clearly visualized as anatomical landmarks. After confirming the correct location with saline injection, 50 mg of 0.25% bupivacaine will be administered.
QIP Block Procedure:
With the patient in the prone position, a low-frequency convex transducer (2-6 MHz) and a 22G x 100 mm peripheral nerve block needle (Stimuplex® Ultra 360®, B-Braun) will be used. The transducer will be placed transversely at the L3 level to identify the spinal processes, followed by lateral movement to visualize the transverse process within the erector spinae muscle. The transducer will then be rotated parasagittally and moved caudally to locate where the Quadratus Lumborum muscle (QLM) attaches to the iliac crest. After confirming the location with saline, 50 mg of 0.25% bupivacaine will be administered under the fascia of the QLM.
Postoperative Analgesia:
Patients will receive intravenous patient-controlled analgesia (PCA) with 2 mg/mL Tramadol HCl in 100 mL NaCl solution, delivered via bolus doses of 20 mg with a 20-minute lockout period and a total dose limit of 200 mg over 4 hours. Pain scores using the visual analog scale (VAS) will be recorded at rest and with movement at 0, 6, 12, and 24 hours. The total opioid consumption and the need for rescue analgesia (50 mg deksketoprofen in 100 mL mediflex over 20 minutes) will also be assessed. Routine administration of 1 g of intravenous paracetamol will be given at 6 hours postoperatively.
- Conditions
- Femur Fractures
- Being tested
- PENG Block, Quadro-Iliac plane block
- Keywords
- postoperative pain management, fascial plan blocks, pain, analgesia
- Medical subject headings
- Femoral Fractures, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
With the patient in the supine position, the ultrasound probe is placed transversely over the anterior superior iliac spine (ASIS). After identifying the ASIS, the transducer is aligned with the pubic ramus and rotated approximately 45 degrees to become parallel to the inguinal crease. The transducer is moved medially until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and psoas tendon are clearly visualized as anatomical landmarks. After confirming the correct location with saline injection, 50 mg of 0.25% bupivacaine will be administered.
Quadro-Iliac plane blockProcedure or surgery
With the patient in the prone position, a low-frequency convex transducer (2-6 MHz) and a 22G x 100 mm peripheral nerve block needle (Stimuplex® Ultra 360®, B-Braun) will be used. The transducer will be placed transversely at the L3 level to identify the spinal processes, followed by lateral movement to visualize the transverse process within the erector spinae muscle. The transducer will then be rotated parasagittally and moved caudally to locate where the Quadratus Lumborum muscle (QLM) attaches to the iliac crest. After confirming the location with saline, 50 mg of 0.25% bupivacaine will be administered under the fascia of the QLM.
| Study group | Role | What they receive |
|---|---|---|
| opioid consumption | Active comparator | opioid consumption of the patients in patient controlled analgesia device Receives: Procedure: PENG Block; Procedure: Quadro-Iliac plane block |
| Visual Analogue Scale scores of the patients | Active comparator | Visual Analogue Scale scores of the patients Receives: Procedure: PENG Block; Procedure: Quadro-Iliac plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
Opioid consumption in 24 hours will compared between these two block
Measured: 1 day
Secondary outcomes (1)
Visual Analogue Scale
Visual Analogue Scale scores (0-10) of tge patients will be compared between these two groups in 24 hours
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FracturesStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604806
- Sponsor's protocol ID
- QIP-PFN
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Quadroiliac Plane Block and Pericapsular Nerve Group (PENG) Block in Femoral Fractures: A Multicenter Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT06604806
- Acronym / sponsor ID
- QIP-PFN
- Conditions
- Femur Fractures
- Keywords
- postoperative pain management, fascial plan blocks, pain, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 20 Sep 2024 (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.
This prospective, multicenter study will compare the postoperative analgesic efficacy of the Quadroiliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) block in patients undergoing femoral neck fracture surgery. Eligible patients will be randomly assigned to receive one of the blocks postoperatively under spinal anesthesia. The blocks will be administered by experienced anesthesiologists, and informed consent will be obtained from all participants.
Pain levels will be assessed using the visual analog scale (VAS) at rest and during movement at 0, 6, 12, and 24 hours post-surgery. Opioid consumption will be recorded through patient-controlled analgesia (PCA), and any need for rescue analgesia will be evaluated. Routine postoperative pain management will also include intravenous paracetamol.
Detailed description
This prospective, multicenter, observational study will be conducted at Başakşehir Çam and Sakura City Hospital and Kanuni Sultan Süleyman Training and Research Hospital. The study will include patients aged 18 and older, with an ASA score of I-II-III, undergoing femoral neck fracture surgery under spinal anesthesia. Patients with no history of bleeding diathesis, anticoagulant use, or allergies to the drugs used in the study, and without neuropathic diseases such as diabetes mellitus, will be randomly assigned to receive either the Pericapsular Nerve Group (PENG) block or the Quadroiliac Plane Block (QIPB) postoperatively.
Informed consent will be obtained from all patients, and detailed explanations of both blocks will be provided. Randomization will be performed using a computer program, assigning patients to either block method. Sealed envelopes will be provided to the anesthesiologists, who will apply the block indicated in the envelope at the end of surgery. Both blocks will be performed by experienced anesthesiologists, and only patients operated on under spinal anesthesia will be included in the study.
PENG Block Procedure:
With the patient in the supine position, the ultrasound probe is placed transversely over the anterior superior iliac spine (ASIS). After identifying the ASIS, the transducer is aligned with the pubic ramus and rotated approximately 45 degrees to become parallel to the inguinal crease. The transducer is moved medially until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and psoas tendon are clearly visualized as anatomical landmarks. After confirming the correct location with saline injection, 50 mg of 0.25% bupivacaine will be administered.
QIP Block Procedure:
With the patient in the prone position, a low-frequency convex transducer (2-6 MHz) and a 22G x 100 mm peripheral nerve block needle (Stimuplex® Ultra 360®, B-Braun) will be used. The transducer will be placed transversely at the L3 level to identify the spinal processes, followed by lateral movement to visualize the transverse process within the erector spinae muscle. The transducer will then be rotated parasagittally and moved caudally to locate where the Quadratus Lumborum muscle (QLM) attaches to the iliac crest. After confirming the location with saline, 50 mg of 0.25% bupivacaine will be administered under the fascia of the QLM.
Postoperative Analgesia:
Patients will receive intravenous patient-controlled analgesia (PCA) with 2 mg/mL Tramadol HCl in 100 mL NaCl solution, delivered via bolus doses of 20 mg with a 20-minute lockout period and a total dose limit of 200 mg over 4 hours. Pain scores using the visual analog scale (VAS) will be recorded at rest and with movement at 0, 6, 12, and 24 hours. The total opioid consumption and the need for rescue analgesia (50 mg deksketoprofen in 100 mL mediflex over 20 minutes) will also be assessed. Routine administration of 1 g of intravenous paracetamol will be given at 6 hours postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid consumption | Active comparator | Procedure: PENG Block, Procedure: Quadro-Iliac plane blockopioid consumption of the patients in patient controlled analgesia device |
| Visual Analogue Scale scores of the patients | Active comparator | Procedure: PENG Block, Procedure: Quadro-Iliac plane blockVisual Analogue Scale scores of the patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients and their relatives have provided informed consent,
- Patients aged 18 years or older undergoing femoral fracture surgery,
- ASA score of I-III,
- No history of bleeding diathesis,
- No history of anticoagulant use that contraindicates block application according to guidelines,
Key exclusion criteria (12 listed)
- Lack of informed consent from the patient or their relatives,
- Development of complications during the surgical procedure,
- Need for revision surgery,
- Patient\'s desire to withdraw from the study,
- Patients under the age of 18,
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 BlockWith the patient in the supine position, the ultrasound probe is placed transversely over the anterior superior iliac spine (ASIS). After identifying the ASIS, the transducer is aligned with the pubic ramus and rotated approximately 45 degrees to become parallel to the inguinal crease. The transducer is moved medially until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and psoas tendon are clearly visualized as anatomical landmarks. After confirming the correct location with saline injection, 50 mg of 0.25% bupivacaine will be administered. | Procedure or surgery | Visual Analogue Scale scores of the patients, opioid consumption |
| Quadro-Iliac plane blockWith the patient in the prone position, a low-frequency convex transducer (2-6 MHz) and a 22G x 100 mm peripheral nerve block needle (Stimuplex® Ultra 360®, B-Braun) will be used. The transducer will be placed transversely at the L3 level to identify the spinal processes, followed by lateral movement to visualize the transverse process within the erector spinae muscle. The transducer will then be rotated parasagittally and moved caudally to locate where the Quadratus Lumborum muscle (QLM) attaches to the iliac crest. After confirming the location with saline, 50 mg of 0.25% bupivacaine will be administered under the fascia of the QLM. | Procedure or surgery | Visual Analogue Scale scores of the patients, opioid consumption |
Primary outcome
opioid consumption
Time frame: 1 day
Opioid consumption in 24 hours will compared between these two block
1 secondary outcome
Visual Analogue Scale
Time frame: 1 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 18 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Quadro-Iliac plane block in people with Femur Fractures, run by Kanuni Sultan Suleyman Training and Research Hospital 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 7 inclusion and 12 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 18 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?
opioid consumption (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.