Fractures, HipPhase 4NCT07130006
Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures
A Phase 4 study testing PENG and LFCN peripheral nerve blocks with spinal anesthesia, FN and LFCN peripheral nerve blocks with spinal anesthesia and FIC peripheral nerve block with spinal anesthesia in people with Fractures, Hip and Femoral Neck Fractures, run by University Hospital of Split at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fractures, Hip, Femoral Neck Fractures, Intertrochanteric Fractures
- What is being tested?
- PENG and LFCN peripheral nerve blocks with spinal anesthesia, FN and LFCN peripheral nerve blocks with spinal anesthesia and FIC peripheral nerve block with spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteCroatia
- Study dates
- 30 Aug 2025to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sexes
- 60 years old and older
- diagnosed with a hip fracture resulting from low-energy trauma
- scheduled surgery.
Who cannot join
- polytraumatized patients
- dementia and acute psychosis patients
- patients for whom spinal anesthesia is contraindicated
- patients with severe renal failure
- patients for whom intravenous administration of tranexamic acid is contraindicated
- patients with proven allergy and contraindications to dexamethasone, non-steroidal anti-rheumatic drugs, opioid analgesics, magnesium sulfate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures: a Factorial Randomized Clinical Trial
The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. The main questions this trial aims to answer are:
- which peripheral nerve block is the best regarding analgesia
- which peripheral nerve block eases positioning and decrease time necessary for applying spinal anesthesia?
- which peripheral nerve block is associated with reduced intake of analgesics, both oral and intravenous?
- which peripheral nerve block lasts long enough but does not interfere with the start of physical therapy?
- what medical problems do respondents have during their hospitalization, after administration of peripheral nerve blocks, spinal anesthesia and surgery?
- what medical problems arise as a consequence of their complex medical history? Researchers will compare respondents who receive peripheral nerve blocks to those who do not. Those who do not receive blocks will be given fentanyl preoperatively, which was until recently standard at our institution.
Read more
All respondents will, in addition to obligatory intraoperative monitoring,:
- be thoroughly examined by anesthesiologists before surgery
- be closely monitored after surgery, until their hospital discharge.
Read the detailed description
The aging of the population is a global trend. In the elderly population, hip fractures are among the leading reasons for hospitalization and in most cases require surgical treatment. When we talk about hip fractures, we actually mean fractures of the proximal femur, which are classified according to the AO school as extracapsular (trochanteric region) and intracapsular (femoral neck area). Articular fractures (femoral head area) are very rare and not the subject of this study.
Patients with hip fractures, in addition to their advanced age, have numerous comorbidities. That is why mortality rate is high, up to 36% within a year of surgery, and perioperative care of such patients is a challenge for everyone involved in their treatment, especially surgeons and anesthesiologists. Despite this, to this date our institution has no protocol that would ensure standardization of the care in perioperative period, although this is recommended by professional societies. That is why we designed this study, in which we emphasize use of regional anesthesia in elderly patients.
The goal of this clinical trial is to promote usage of peripheral nerve blocks. Based on our clinical experience, peripheral nerve blocks act as aids for spinal anesthesia positioning and are a crucial part of peri-operative multimodal analgesia protocols in elderly patients scheduled for hip fracture surgery.
We believe that our results will show that peripheral nerve blocks decrease pain and amount of analgesics used in perioperative period, per mouth as well as intravenously. However, in order to include their use into standard operating protocols, we need to determine which block is the best for our group of patients, considering different types of fractures and types of surgeries. We also need to determine which block provides the best analgesia, both for positioning for spinal anesthesia and postoperatively, which block lasts the longest, while not interfering with the start of physical therapy and not prolonging hospital stay.
Primary outcome of this research is to determine pain. It will be determined using visual analogue scale, at rest and dynamically, while leg is being passively raised for 15˚.
Secondary outcomes are: patient reported outcome using EQ-5D-5L, time for the performance of blocks, ease of positioning and time to positioning to spinal, as well as time for the performance of spinal anesthesia, time until the first rescue analgesia and total analgesics used, total duration of blocks, level of motor blockade and time of the initiation of physical therapy, as well as any adverse effects until hospital discharge.
After meeting our inclusion and exclusion criteria, patients will be offered to participate in the research, as respondents. After signing informative consent, they will be randomized into one of four groups, 3 interventional and one control group. Each group will have an equal number of subjects with intracapsular and extracapsular hip fractures. Respondents will not know to which group they have been randomized, nor will the surgeons, nurses and anesthesiology residents. Anesthesiologists will therefore be considered as the study supervisors. Respondents will be closely monitored until hospital discharge.
Anesthesiologist's examination before the surgery will consist of recording body weight and height, determining BMI, noting down history and comorbidities using ASA status, frailty score (Clinical Frailty Test), cognitive status (Mini Mental State Exam), laboratory results (L, WBC, CRP, IL-6, Hb, Htc, ferritin, TSAT, urea, creatinine, eGFR, PLT, PV, INR, APTV, electrolytes) and introducing EQ-5D-5L to respondents. Preoperative fasting will be ensured (6 - 8 hours), clear liquids allowed up to 2 hours before surgery. Upon arrival to the operating block, in the preparation room, respondents will be analgosedated with esketamine 5mg and fentanyl 50 mcg for the administration of peripheral nerve block. Application of peripheral nerve block will be made using ultrasound (linear or curvilinear probe, depending on the block) and regional needles (Pajunk, 21G, length 100 mm). Respondents will be monitored all the time and 20 minutes after administration of the block they will be asked to answer EQ-5D-5L for the second time. After that, they will be positioned for spinal in sitting position. 5 minutes after the spinal they will be asked EQ-5D-5L for the third time and then transported to the operating room. Before the incision, cefazoline and tranexamic acid will be administered. Respondents will be lightly to moderately sedated during surgery (RASS -2 to -3), with propofol and esketamine, sequenced. Normovolemia will be maintained. Intraoperative hypotension will be treated with ephedrine, phenylephrine or norepinephrine. Normothermia will be maintained using passive heating (active if necessary) and body temperature will be measured. Multimodal analgesia will be continued with paracetamol, ketoprofen, dexamethasone and MgSO4. Granisetron will be given as well. Postoperatively, they will answer EQ-5D-5L 4 more times: upon leaving recovery room and operative block, 6 hours after the surgery, 24h and 48h after.
Postoperatively, time until the rescue dose of analgesics will be noted. Analgesics, when necessary, will be introduced in this order: Paracetamol 1 g iv., Diclofenac 75 mg im., Tramadol 50 mg iv., Morphine 2 - 5 mg sc. or iv. After respondents start taking fluids and food per mouth (after 1 hour of receiving fluids, food can be given, or according to the patient's tolerance, but as soon as possible), they can start using analgesics orally. Laboratory results will be done 24h after the surgery, as well as MMSE.
Bromage test for motor blockade will be performed 20 minutes after the block, upon exit from the recovery room, 6h, 24h and 48h after the surgery. Respondents' ability to participate in physical therapy will also be monitored.
- Conditions
- Fractures, Hip, Femoral Neck Fractures, Intertrochanteric Fractures, Subtrochanteric Fractures, Aged, Frail Older Adults
- Being tested
- PENG and LFCN peripheral nerve blocks with spinal anesthesia, FN and LFCN peripheral nerve blocks with spinal anesthesia, FIC peripheral nerve block with spinal anesthesia, Fentanyl (IV) with spinal anesthesia
- Keywords
- elderly, ultrasound-guided, peripheral nerve blocks, intravenous fentanyl, spinal anaesthesia, EQ-5D-5L, visual analog scale, pain at rest, dynamic pain, hip fracture surgery
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG and LFCN peripheral nerve blocks with spinal anesthesiaProcedure or surgery
At first, one needs to detect hyperechogenic iliopsoas notch and psoas tendon, between anterior inferior iliac spine and iliopubic eminence. Then needle needs to be inserted in-plane and 20mL of levobupivacaine 0.25% administered along the fascial plane. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Curvilinear probe will be used.
For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.
FN and LFCN peripheral nerve blocks with spinal anesthesiaProcedure or surgery
At first, one needs to detect both femoral artery and vein medial to it. Then needle needs to be inserted in-plane and 15mL of levobupivacaine 0.5% need to be administered underneath fascia iliaca, lateral to femoral nerve. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles, where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Linear probe will be used.
For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.
FIC peripheral nerve block with spinal anesthesiaProcedure or surgery
Suprainguinal approach will be performed. At first, one needs to detect anterior inferior iliac spine, sartorius and internal oblique muscles creating a bow-tie. Deep circumflex iliac artery will be seen between transversus abdominis and iliacus muscle. Then needle needs to be inserted in-plane and 40mL of levobupivacaine 0.25% administered along the fascial plane so that fascia separates from iliacus muscle. The needle is inserted from caudal to cranial, to achieve the widest possible spread of local anesthetic under the fascia, to the cranial side, as this reaches both lateral femoral cutaneous nerve and femoral nerve. The spread of anesthetic will appear hypoechoic on ultrasound. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.
Fentanyl (IV) with spinal anesthesiaProcedure or surgery
A total dose of 2 mcg/kg of fentanyl will be given to patients before positioning to spinal. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.
| Study group | Role | What they receive |
|---|---|---|
| Intracapsular hip fracture FEMORAL BLOCK | Active comparator | Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture. Receives: Procedure: FN and LFCN peripheral nerve blocks with spinal anesthesia |
| Intracapsular hip fracture PENG BLOCK | Active comparator | Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture. Receives: Procedure: PENG and LFCN peripheral nerve blocks with spinal anesthesia |
| Intracapsular hip fracture FASCIA ILIACA BLOCK | Active comparator | Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture. Receives: Procedure: FIC peripheral nerve block with spinal anesthesia |
| Intracapsular hip fracture FENTANYL | Active comparator | Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for partial endoprothesis of hip fracture. Receives: Procedure: Fentanyl (IV) with spinal anesthesia |
| Extracapsular hip fracture FEMORAL BLOCK | Active comparator | Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture. Receives: Procedure: FN and LFCN peripheral nerve blocks with spinal anesthesia |
| Extracapsular hip fracture PENG BLOCK | Active comparator | Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture. Receives: Procedure: PENG and LFCN peripheral nerve blocks with spinal anesthesia |
| Extracapsular hip fracture FASCIA ILIACA BLOCK | Active comparator | Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for osteosinthesis of hip fracture. Receives: Procedure: FIC peripheral nerve block with spinal anesthesia |
| Extracapsular hip fracture FENTANYL | Active comparator | Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for osteosinthesis of hip fracture. Receives: Procedure: Fentanyl (IV) with spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
The primary outcome measures of this research is pain relief after the administration of peripheral nerve block. Pain will be measured using VAS scale, as a part of one of EQ-5D-5L, at rest and during passive 15˚ leg rising. VAS is the most commonly used scale for pain measurement. VAS ratings (100-mm) of 0 to 4 mm will be considered as no pain; 5 to 44 mm as mild pain; 45 to 74 mm as moderate pain and 75 - 100 mm as severe pain. Cut off values for VAS vary depending on the context and the population. However, 33% decrease in pain is a reasonable standard for determining that a treatment provides meaningful relief.
Measured: 20 minutes after application of the local anesthetic
Secondary outcomes (10)
Health Outcome
Qualitative measure of health outcome will be measured using EQ-5D-5L. Respondents will use it as a self-report, self-complete measure 7 times.
Measured: before application of the block, 20 minutes after application of the block, 5 minutes after application of spinal anesthesia, 2 hours after the operation (upon leaving the recovery room), 6 hours, 24 hours and 48 hours after the operation.
Time for the performance of peripheral nerve block
Upon arrival to the block room, respondents need to be monitored, with iv. access obtained, and positioned appropriately. Since these are peripheral nerve blocks, only sterile gloves and antiseptic cleaning solution should be used. A local anesthetic is injected near a specific peripheral nerve, in proximity of a tendon or underneath the fascia. This is achieved using anatomical landmarks and ultrasound guidance. Time for clean up post procedure is also calculated into time to perform blocks. This is measured in minutes.
Measured: Before surgery.
Time for the performance of spinal anesthesia in a sitting position
Time to perform spinal anesthesia will be measured in minutes. This interval can be broken down into: monitoring patients, preparing equipment, sitting the patient up, preparing the skin and administering intrathecal injection. This time will be measured in minutes. We will also record ease of positioning respondents to spinal using EOSP score (0 - 3, with higher scores indicating greater ease of positioning and less discomfort), with special emphasis given to time for positioning patients into sitting position (in minutes).
Measured: Before surgery
Rescue analgesics
We will note the time until patients start asking for analgesics (in minutes) and total quantity of analgetics used (in morphine equivalents).
Measured: After surgery, up to 48 hours
Duration of peripheral nerve blocks
We will note down total duration of blocks (in hours). We will assess motor blockade using Bromage scale.
Measured: 20 minutes after the block and 6 hours, 24 hours and 48 hours post surgery
Time to the start of physical therapy
We will note down when respondents start exercising in bed - passively or actively, sitting - assisted or independently, when they are verticalized - assisted or independently, and when they start walking with aids - assisted or independently.
Measured: After surgery, up to 48 hours
Development of complications
We will note any adverse effects, if they arise. Complications can be consequences of trauma itself, peripheral nerve blocks, spinal anesthesia and operation itself.
Measured: From the admission, until hospital discharge.
Postoperative nausea
Since nausea usually accompanies pain, it will be assessed using VAS scale. 0 is for no nausea and 10 is worst nausea with retching - 20 minutes after application of the block, 5 minutes after application of spinal anesthesia, 2 hours after the operation (upon leaving the recovery room), 6 hours, 24 hours and 48 hours after the operation. Cut off value of 40 will be used as a critical threshold triggering administration of rescue medication.
Measured: After surgery, up to 48 hours
Anxiety
Since anxiety usually accompanies pain, it will be assessed using VAS scale. 0 is for no anxiety and 10 is worst possible anxiety. It will be monitored 20 minutes after application of the block, 5 minutes after application of spinal anesthesia, 2 hours after the operation (upon leaving the recovery room), 6 hours, 24 hours and 48 hours after the operation. Cut off value of 40 will be used as a critical threshold triggering administration of rescue medication.
Measured: After surgery, up to 48 hours
Quality of recovery
QoR-15 will be introduced to patients the day before, as a measure of baseline status, and 24 hours after the surgery, as a measure of quality of recovery after anesthesia and surgery.
Measured: Before and 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fractures, HipStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factorial randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Saric Jadrijev, University Hospital of Split
- Investigators
- Ana Saric Jadrijev, MD, Principal investigator, Department of Anaesthesiology and Intensive Care, University Hospital of SplitRuben Kovac, MD, Study chair, Department of Anaesthesiology and Intensive Care, University Hospital of SplitMarija Kljucevic, MD, Study chair, Department of Anaesthesiology and Intensive Care, University Hospital of SplitPetra Bajto, MD, Study chair, Department of Anaesthesiology and Intensive Care, University Hospital of SplitMeri Mirceta, MD, Study chair, Department of Anaesthesiology and Intensive Care, University Hospital of SplitAna Maria Mitar, MD, Study chair, Department of Anaesthesiology and Intensive Care, University Hospital of SplitAna Bego, MD, Study chair, Department of Anaesthesiology and Intensive Care, University Hospital of SplitJosipa Modric, MD, Study chair, Department of Anaesthesiology and Intensive Care, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130006
- Sponsor's protocol ID
- 2181-147/01-06/LJ.Z.-25.02.
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soltani Mohammadi S, Piri M, Khajehnasiri A. Comparing Three Different Modified Sitting Positions for Ease of Spinal Needle Insertion in Patients Undergoing Spinal Anesthesia. Anesth Pain Med. 2017 Oct 23;7(5):e55932. doi: 10.5812/aapm.55932. eCollection 2017 Oct.
PubMed 29696117Sharma A, Rana S, Gupta B, Ranaut A, Khanoria R, Bhardwaj N. Evaluation of two doses (20 mL and 15 mL) of 0.25% bupivacaine in pericapsular nerve group block for patient positioning for sub-arachnoid block during hip fracture surgery: A single-centre, randomised comparative trial. Indian J Anaesth. 2024 Apr;68(4):323-328. doi: 10.4103/ija.ija_258_23. Epub 2024 Mar 13.
PubMed 38586258Rajkumar HB, Ramachandran A, Palanisamy N. Comparison of Ultrasound-Guided Femoral Nerve Block and Intravenous Fentanyl For Analgesia During Positioning of Patients With Femur Fracture for Combined Spinal-Epidural Anesthesia: A Randomized Controlled Study. Cureus. 2025 May 15;17(5):e84201. doi: 10.7759/cureus.84201. eCollection 2025 May.
PubMed 40525078Maniar A, Macachor J, Chiew WA, Kumar CM, Imani F, Rokhtabnak F. Nuts and Bolts of Peripheral Nerve Blocks for Pain After Hip Fracture for Everyday Anesthetist. Anesth Pain Med. 2021 Aug 29;11(4):e116099. doi: 10.5812/aapm.116099. eCollection 2021 Aug.
PubMed 34692438Jadon A, Mohsin K, Sahoo RK, Chakraborty S, Sinha N, Bakshi A. Comparison of supra-inguinal fascia iliaca versus pericapsular nerve block for ease of positioning during spinal anaesthesia: A randomised double-blinded trial. Indian J Anaesth. 2021 Aug;65(8):572-578. doi: 10.4103/ija.ija_417_21. Epub 2021 Aug 25.
PubMed 34584279Comeau-Gauthier M, Bhandari M. Cochrane in CORR(R): Peripheral Nerve Blocks for Hip Fracture Surgery in Adults. Clin Orthop Relat Res. 2021 May 1;479(5):885-891. doi: 10.1097/CORR.0000000000001764. No abstract available.
PubMed 33835102
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures: a Factorial Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07130006
- Acronym / sponsor ID
- 2181-147/01-06/LJ.Z.-25.02.
- Conditions
- Fractures, Hip, Femoral Neck Fractures, Intertrochanteric Fractures, Subtrochanteric Fractures, Aged, Frail Older Adults
- Keywords
- elderly, ultrasound-guided, peripheral nerve blocks, intravenous fentanyl, spinal anaesthesia, EQ-5D-5L, visual analog scale, pain at rest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Aug 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.
The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. The main questions this trial aims to answer are:
- which peripheral nerve block is the best regarding analgesia
- which peripheral nerve block eases positioning and decrease time necessary for applying spinal anesthesia?
- which peripheral nerve block is associated with reduced intake of analgesics, both oral and intravenous?
- which peripheral nerve block lasts long enough but does not interfere with the start of physical therapy?
- what medical problems do respondents have during their hospitalization, after administration of peripheral nerve blocks, spinal anesthesia and surgery?
- what medical problems arise as a consequence of their complex medical history? Researchers will compare respondents who receive peripheral nerve blocks to those who do not. Those who do not receive blocks will be given fentanyl preoperatively, which was until recently standard at our institution.
All respondents will, in addition to obligatory intraoperative monitoring,:
- be thoroughly examined by anesthesiologists before surgery
- be closely monitored after surgery, until their hospital discharge.
Detailed description
The aging of the population is a global trend. In the elderly population, hip fractures are among the leading reasons for hospitalization and in most cases require surgical treatment. When we talk about hip fractures, we actually mean fractures of the proximal femur, which are classified according to the AO school as extracapsular (trochanteric region) and intracapsular (femoral neck area). Articular fractures (femoral head area) are very rare and not the subject of this study.
Patients with hip fractures, in addition to their advanced age, have numerous comorbidities. That is why mortality rate is high, up to 36% within a year of surgery, and perioperative care of such patients is a challenge for everyone involved in their treatment, especially surgeons and anesthesiologists. Despite this, to this date our institution has no protocol that would ensure standardization of the care in perioperative period, although this is recommended by professional societies. That is why we designed this study, in which we emphasize use of regional anesthesia in elderly patients.
The goal of this clinical trial is to promote usage of peripheral nerve blocks. Based on our clinical experience, peripheral nerve blocks act as aids for spinal anesthesia positioning and are a crucial part of peri-operative multimodal analgesia protocols in elderly patients scheduled for hip fracture surgery.
We believe that our results will show that peripheral nerve blocks decrease pain and amount of analgesics used in perioperative period, per mouth as well as intravenously. However, in order to include their use into standard operating protocols, we need to determine which block is the best for our group of patients, considering different types of fractures and types of surgeries. We also need to determine which block provides the best analgesia, both for positioning for spinal anesthesia and postoperatively, which block lasts the longest, while not interfering with the start of physical therapy and not prolonging hospital stay.
Primary outcome of this research is to determine pain. It will be determined using visual analogue scale, at rest and dynamically, while leg is being passively raised for 15˚.
Secondary outcomes are: patient reported outcome using EQ-5D-5L, time for the performance of blocks, ease of positioning and time to positioning to spinal, as well as time for the performance of spinal anesthesia, time until the first rescue analgesia and total analgesics used, total duration of blocks, level of motor blockade and time of the initiation of physical therapy, as well as any adverse effects until hospital discharge.
After meeting our inclusion and exclusion criteria, patients will be offered to participate in the research, as respondents. After signing informative consent, they will be randomized into one of four groups, 3 interventional and one control group. Each group will have an equal number of subjects with intracapsular and extracapsular hip fractures. Respondents will not know to which group they have been randomized, nor will the surgeons, nurses and anesthesiology residents. Anesthesiologists will therefore be considered as the study supervisors. Respondents will be closely monitored until hospital discharge.
Anesthesiologist's examination before the surgery will consist of recording body weight and height, determining BMI, noting down history and comorbidities using ASA status, frailty score (Clinical Frailty Test), cognitive status (Mini Mental State Exam), laboratory results (L, WBC, CRP, IL-6, Hb, Htc, ferritin, TSAT, urea, creatinine, eGFR, PLT, PV, INR, APTV, electrolytes) and introducing EQ-5D-5L to respondents. Preoperative fasting will be ensured (6 - 8 hours), clear liquids allowed up to 2 hours before surgery. Upon arrival to the operating block, in the preparation room, respondents will be analgosedated with esketamine 5mg and fentanyl 50 mcg for the administration of peripheral nerve block. Application of peripheral nerve block will be made using ultrasound (linear or curvilinear probe, depending on the block) and regional needles (Pajunk, 21G, length 100 mm). Respondents will be monitored all the time and 20 minutes after administration of the block they will be asked to answer EQ-5D-5L for the second time. After that, they will be positioned for spinal in sitting position. 5 minutes after the spinal they will be asked EQ-5D-5L for the third time and then transported to the operating room. Before the incision, cefazoline and tranexamic acid will be administered. Respondents will be lightly to moderately sedated during surgery (RASS -2 to -3), with propofol and esketamine, sequenced. Normovolemia will be maintained. Intraoperative hypotension will be treated with ephedrine, phenylephrine or norepinephrine. Normothermia will be maintained using passive heating (active if necessary) and body temperature will be measured. Multimodal analgesia will be continued with paracetamol, ketoprofen, dexamethasone and MgSO4. Granisetron will be given as well. Postoperatively, they will answer EQ-5D-5L 4 more times: upon leaving recovery room and operative block, 6 hours after the surgery, 24h and 48h after.
Postoperatively, time until the rescue dose of analgesics will be noted. Analgesics, when necessary, will be introduced in this order: Paracetamol 1 g iv., Diclofenac 75 mg im., Tramadol 50 mg iv., Morphine 2 - 5 mg sc. or iv. After respondents start taking fluids and food per mouth (after 1 hour of receiving fluids, food can be given, or according to the patient's tolerance, but as soon as possible), they can start using analgesics orally. Laboratory results will be done 24h after the surgery, as well as MMSE.
Bromage test for motor blockade will be performed 20 minutes after the block, upon exit from the recovery room, 6h, 24h and 48h after the surgery. Respondents' ability to participate in physical therapy will also be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 8
- Model description
- Factorial randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intracapsular hip fracture FEMORAL BLOCK | Active comparator | Procedure: FN and LFCN peripheral nerve blocks with spinal anesthesiaPatients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture. |
| Intracapsular hip fracture PENG BLOCK | Active comparator | Procedure: PENG and LFCN peripheral nerve blocks with spinal anesthesiaPatients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture. |
| Intracapsular hip fracture FASCIA ILIACA BLOCK | Active comparator | Procedure: FIC peripheral nerve block with spinal anesthesiaPatients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture. |
| Intracapsular hip fracture FENTANYL | Active comparator | Procedure: Fentanyl (IV) with spinal anesthesiaPatients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for partial endoprothesis of hip fracture. |
| Extracapsular hip fracture FEMORAL BLOCK | Active comparator | Procedure: FN and LFCN peripheral nerve blocks with spinal anesthesiaPatients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture. |
| Extracapsular hip fracture PENG BLOCK | Active comparator | Procedure: PENG and LFCN peripheral nerve blocks with spinal anesthesiaPatients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture. |
| Extracapsular hip fracture FASCIA ILIACA BLOCK | Active comparator | Procedure: FIC peripheral nerve block with spinal anesthesiaPatients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for osteosinthesis of hip fracture. |
| Extracapsular hip fracture FENTANYL | Active comparator | Procedure: Fentanyl (IV) with spinal anesthesiaPatients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for osteosinthesis of hip fracture. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- both sexes
- 60 years old and older
- diagnosed with a hip fracture resulting from low-energy trauma
- scheduled surgery.
Key exclusion criteria (6 listed)
- polytraumatized patients
- dementia and acute psychosis patients
- patients for whom spinal anesthesia is contraindicated
- patients with severe renal failure
- patients for whom intravenous administration of tranexamic acid is contraindicated
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 and LFCN peripheral nerve blocks with spinal anesthesiaAt first, one needs to detect hyperechogenic iliopsoas notch and psoas tendon, between anterior inferior iliac spine and iliopubic eminence. Then needle needs to be inserted in-plane and 20mL of levobupivacaine 0.25% administered along the fascial plane. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Curvilinear probe will be used. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle. | Procedure or surgery | Extracapsular hip fracture PENG BLOCK, Intracapsular hip fracture PENG BLOCK |
| FN and LFCN peripheral nerve blocks with spinal anesthesiaAt first, one needs to detect both femoral artery and vein medial to it. Then needle needs to be inserted in-plane and 15mL of levobupivacaine 0.5% need to be administered underneath fascia iliaca, lateral to femoral nerve. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles, where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Linear probe will be used. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle. | Procedure or surgery | Extracapsular hip fracture FEMORAL BLOCK, Intracapsular hip fracture FEMORAL BLOCK |
| FIC peripheral nerve block with spinal anesthesiaSuprainguinal approach will be performed. At first, one needs to detect anterior inferior iliac spine, sartorius and internal oblique muscles creating a bow-tie. Deep circumflex iliac artery will be seen between transversus abdominis and iliacus muscle. Then needle needs to be inserted in-plane and 40mL of levobupivacaine 0.25% administered along the fascial plane so that fascia separates from iliacus muscle. The needle is inserted from caudal to cranial, to achieve the widest possible spread of local anesthetic under the fascia, to the cranial side, as this reaches both lateral femoral cutaneous nerve and femoral nerve. The spread of anesthetic will appear hypoechoic on ultrasound. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle. | Procedure or surgery | Extracapsular hip fracture FASCIA ILIACA BLOCK, Intracapsular hip fracture FASCIA ILIACA BLOCK |
| Fentanyl (IV) with spinal anesthesiaA total dose of 2 mcg/kg of fentanyl will be given to patients before positioning to spinal. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle. | Procedure or surgery | Extracapsular hip fracture FENTANYL, Intracapsular hip fracture FENTANYL |
Primary outcome
Pain relief
Time frame: 20 minutes after application of the local anesthetic
The primary outcome measures of this research is pain relief after the administration of peripheral nerve block. Pain will be measured using VAS scale, as a part of one of EQ-5D-5L, at rest and during passive 15˚ leg rising. VAS is the most commonly used scale for pain measurement. VAS ratings (100-mm) of 0 to 4 mm will be considered as no pain; 5 to 44 mm as mild pain; 45 to 74 mm as moderate pain and 75 - 100 mm as severe pain. Cut off values for VAS vary depending on the context and the population. However, 33% decrease in pain is a reasonable standard for determining that a treatment provides meaningful relief.
10 secondary outcomes
Health Outcome
Time frame: before application of the block, 20 minutes after application of the block, 5 minutes after application of spinal anesthesia, 2 hours after the operation (upon leaving the recovery room), 6 hours, 24 hours and 48 hours after the operation.
Time for the performance of peripheral nerve block
Time frame: Before surgery.
Time for the performance of spinal anesthesia in a sitting position
Time frame: Before surgery
Rescue analgesics
Time frame: After surgery, up to 48 hours
Duration of peripheral nerve blocks
Time frame: 20 minutes after the block and 6 hours, 24 hours and 48 hours post surgery
Time to the start of physical therapy
Time frame: After surgery, up to 48 hours
Development of complications
Time frame: From the admission, until hospital discharge.
Postoperative nausea
Time frame: After surgery, up to 48 hours
Anxiety
Time frame: After surgery, up to 48 hours
Quality of recovery
Time frame: Before and 24 hours after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 29696117Soltani Mohammadi S, Piri M, Khajehnasiri A. Comparing Three Different Modified Sitting Positions for Ease of Spinal Needle Insertion in Patients Undergoing Spinal Anesthesia. Anesth Pain Med. 2017 Oct 23;7(5):e55932. doi: 10.5812/aapm.55932. eCollection 2017 Oct.
- Background: PubMed 38586258Sharma A, Rana S, Gupta B, Ranaut A, Khanoria R, Bhardwaj N. Evaluation of two doses (20 mL and 15 mL) of 0.25% bupivacaine in pericapsular nerve group block for patient positioning for sub-arachnoid block during hip fracture surgery: A single-centre, randomised comparative trial. Indian J Anaesth. 2024 Apr;68(4):323-328. doi: 10.4103/ija.ija_258_23. Epub 2024 Mar 13.
- Background: PubMed 40525078Rajkumar HB, Ramachandran A, Palanisamy N. Comparison of Ultrasound-Guided Femoral Nerve Block and Intravenous Fentanyl For Analgesia During Positioning of Patients With Femur Fracture for Combined Spinal-Epidural Anesthesia: A Randomized Controlled Study. Cureus. 2025 May 15;17(5):e84201. doi: 10.7759/cureus.84201. eCollection 2025 May.
- Background: PubMed 34692438Maniar A, Macachor J, Chiew WA, Kumar CM, Imani F, Rokhtabnak F. Nuts and Bolts of Peripheral Nerve Blocks for Pain After Hip Fracture for Everyday Anesthetist. Anesth Pain Med. 2021 Aug 29;11(4):e116099. doi: 10.5812/aapm.116099. eCollection 2021 Aug.
- Background: PubMed 34584279Jadon A, Mohsin K, Sahoo RK, Chakraborty S, Sinha N, Bakshi A. Comparison of supra-inguinal fascia iliaca versus pericapsular nerve block for ease of positioning during spinal anaesthesia: A randomised double-blinded trial. Indian J Anaesth. 2021 Aug;65(8):572-578. doi: 10.4103/ija.ija_417_21. Epub 2021 Aug 25.
- Background: PubMed 33835102Comeau-Gauthier M, Bhandari M. Cochrane in CORR(R): Peripheral Nerve Blocks for Hip Fracture Surgery in Adults. Clin Orthop Relat Res. 2021 May 1;479(5):885-891. doi: 10.1097/CORR.0000000000001764. No abstract available.
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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.
Ana Saric Jadrijev, MD principal investigator
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Ruben Kovac, MD study chair
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Marija Kljucevic, MD study chair
Department of Anaesthesiology and Intensive Care, University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PENG and LFCN peripheral nerve blocks with spinal anesthesia, FN and LFCN peripheral nerve blocks with spinal anesthesia and FIC peripheral nerve block with spinal anesthesia in people with Fractures, Hip and Femoral Neck Fractures, run by University Hospital of Split at 1 site in Croatia.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Aug 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 Croatia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Saric Jadrijev, MD (385981788627, ana_saric@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 20 minutes after application of the local anesthetic). 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 NCT07130006, which also lists 6 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 19 Aug 2025.