Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures
NCT07130006 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 256
Last updated 2025-08-19
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. 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.
Conditions
- Fractures, Hip
- Femoral Neck Fractures
- Intertrochanteric Fractures
- Subtrochanteric Fractures
- Aged
- Frail Older Adults
- Elderly
Interventions
- PROCEDURE
-
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.
- PROCEDURE
-
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.
- PROCEDURE
-
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.
- PROCEDURE
-
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.
Sponsors & Collaborators
-
University Hospital of Split
lead OTHER
Principal Investigators
-
Ana Saric Jadrijev, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Ruben Kovac, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Marija Kljucevic, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Petra Bajto, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Meri Mirceta, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Ana Maria Mitar, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Ana Bego, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Josipa Modric, MD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Nikola Delic, MD, PhD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Toni Kljakovic-Gaspic, MD, PhD · Department of Anaesthesiology and Intensive Care, University Hospital of Split
-
Nikola Kljucevic, MD, PhD · Department of Surgery, University Hospital of Split
-
Boris Luksic, MD, PhD · Department of Surgery, University Hospital of Split
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-30
- Primary Completion
- 2026-02-28
- Completion
- 2026-03-31
Countries
- Croatia
Study Locations
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