Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital of Split

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

both sexes

60 years old and older

diagnosed with a hip fracture resulting from low-energy trauma

scheduled surgery.

Disqualifiers

polytraumatized patients

dementia and acute psychosis patients

patients for whom spinal anesthesia is contraindicated

patients with severe renal failure

Trial design

Design model

Factorial

Treatments tested in this trial

  • PENG and LFCN peripheral nerve blocks with spinal anesthesia

    Procedure/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 anesthesia

    Procedure/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 anesthesia

    Procedure/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 anesthesia

    Procedure/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.

Treatment groups

256 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Intracapsular hip fracture FEMORAL BLOCKActive comparator 1 intervention
Group B: Intracapsular hip fracture PENG BLOCKActive comparator 1 intervention
Group C: Intracapsular hip fracture FASCIA ILIACA BLOCKActive comparator 1 intervention
Group D: Intracapsular hip fracture FENTANYLActive comparator 1 intervention
Group E: Extracapsular hip fracture FEMORAL BLOCKActive comparator 1 intervention
Group F: Extracapsular hip fracture PENG BLOCKActive comparator 1 intervention
Group G: Extracapsular hip fracture FASCIA ILIACA BLOCKActive comparator 1 intervention
Group H: Extracapsular hip fracture FENTANYLActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
20 minutes after application of the local anesthetic

Secondary outcomes

1

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.

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.
2

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.

Time frame
Before surgery.
3

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).

Time frame
Before surgery
4

Rescue analgesics

We will note the time until patients start asking for analgesics (in minutes) and total quantity of analgetics used (in morphine equivalents).

Time frame
After surgery, up to 48 hours

Other outcomes

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