Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures
NCT ID: NCT07130006
Last Updated: 2025-08-19
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE4
256 participants
INTERVENTIONAL
2025-08-30
2026-03-31
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Intracapsular hip fracture FEMORAL BLOCK
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.
FN and LFCN peripheral nerve blocks with spinal anesthesia
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.
Intracapsular hip fracture PENG BLOCK
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.
PENG and LFCN peripheral nerve blocks with spinal anesthesia
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.
Intracapsular hip fracture FASCIA ILIACA BLOCK
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.
FIC peripheral nerve block with spinal anesthesia
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.
Intracapsular hip fracture FENTANYL
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.
Fentanyl (IV) with spinal anesthesia
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.
Extracapsular hip fracture FEMORAL BLOCK
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.
FN and LFCN peripheral nerve blocks with spinal anesthesia
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.
Extracapsular hip fracture PENG BLOCK
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.
PENG and LFCN peripheral nerve blocks with spinal anesthesia
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.
Extracapsular hip fracture FASCIA ILIACA BLOCK
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.
FIC peripheral nerve block with spinal anesthesia
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.
Extracapsular hip fracture FENTANYL
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.
Fentanyl (IV) with spinal anesthesia
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.
Interventions
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PENG and LFCN peripheral nerve blocks with spinal anesthesia
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 anesthesia
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 anesthesia
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 anesthesia
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.
Eligibility Criteria
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Inclusion Criteria
* 60 years old and older
* diagnosed with a hip fracture resulting from low-energy trauma
* scheduled surgery.
Exclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
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University Hospital of Split
OTHER
Responsible Party
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Ana Saric Jadrijev
MD, Anaesthesiology, Reanimatology and Intensive Medicine Specialist, Principal Investigator
Principal Investigators
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Ana Saric Jadrijev, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Ruben Kovac, MD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Marija Kljucevic, MD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Petra Bajto, MD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Meri Mirceta, MD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Ana Maria Mitar, MD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Ana Bego, MD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Josipa Modric, MD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Nikola Delic, MD, PhD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Toni Kljakovic-Gaspic, MD, PhD
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care, University Hospital of Split
Nikola Kljucevic, MD, PhD
Role: STUDY_CHAIR
Department of Surgery, University Hospital of Split
Boris Luksic, MD, PhD
Role: STUDY_CHAIR
Department of Surgery, University Hospital of Split
Locations
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University Hospital of Split
Split, , Croatia
Countries
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Central Contacts
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References
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Regnault P. The hypoplastic and ptotic breast: a combined operation with prosthetic augmentation. Plast Reconstr Surg. 1966 Jan;37(1):31-7. No abstract available.
Seman AL, Pewen WF, Fresh LF, Martin LN, Murphey-Corb M. The replicative capacity of rhesus macaque peripheral blood mononuclear cells for simian immunodeficiency virus in vitro is predictive of the rate of progression to AIDS in vivo. J Gen Virol. 2000 Oct;81(Pt 10):2441-2449. doi: 10.1099/0022-1317-81-10-2441.
Kim JH, Ju EM, Lee DK, Hwang HJ. Induction of apoptosis by momordin I in promyelocytic leukemia (HL-60) cells. Anticancer Res. 2002 May-Jun;22(3):1885-9.
Nouadje G, Rubie H, Chatelut E, Canal P, Nertz M, Puig P, Couderc F. Child cerebrospinal fluid analysis by capillary electrophoresis and laser-induced fluorescence detection. J Chromatogr A. 1995 Nov 24;717(1-2):293-8. doi: 10.1016/0021-9673(95)00747-3.
Stal P, Hultcrantz R. Iron increases ethanol toxicity in rat liver. J Hepatol. 1993 Jan;17(1):108-15. doi: 10.1016/s0168-8278(05)80530-6.
McCaffrey TV, Olsen KD, Yohanan JM, Lewis JE, Ebersold MJ, Piepgras DG. Factors affecting survival of patients with tumors of the anterior skull base. Laryngoscope. 1994 Aug;104(8 Pt 1):940-5. doi: 10.1288/00005537-199408000-00006.
Other Identifiers
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2181-147/01-06/LJ.Z.-25.02.
Identifier Type: -
Identifier Source: org_study_id
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