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Which Analgesia is Better for Proximal Femoral Fractures?

- Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04309539
Enrollment
100
Registered
2020-03-16
Start date
2020-09-21
Completion date
2022-03-31
Last updated
2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Femur Fracture

Brief summary

This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes. Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.

Detailed description

The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery. Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control. A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum. The ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.

Interventions

A linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of bow-tie sign formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia.

PROCEDUREcombined LFCN block with PENG block

With the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Single-blind study

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) physical status I, II and III.

Exclusion criteria

* Patient refusal. * Neuromuscular diseases * Hematological diseases * Bleeding abnormality * Coagulation abnormality. * Psychiatric diseases. * Local skin infection at the site of the block. * Local skin sepsis at the site of the block * Known intolerance to the study drugs. * Body Mass Index \> 40 Kg/m2. * Multiple trauma patients.

Design outcomes

Primary

MeasureTime frameDescription
Time of performance of Spinal Anesthesiajust before surgery.Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection

Secondary

MeasureTime frameDescription
Pain measurement on movementimmediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.(attempted hip flexion to 15 degrees).: 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Pain measurement during positioning for spinal anesthesiaJust before surgeryvisual analog scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to sitting one
The severity of postoperative pain at restimmediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
The severity of postoperative pain on movementimmediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.(attempted hip flexion to 15 degrees): 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Time to onset of Sensory blockadeevaluated 15 and 30 min after block administrationcold perception loss in the lateral, anterior and medial part of the thigh (corresponding to lateral femoral cutaneous (LFC), femoral (F) and obturator (O)nerve sensory distributions, respectively)
Time to onset of motor blockevaluated 15 and 30 min after block administrationdefined as assessment of quadriceps femoris muscle strength by straight leg raise test to 15 degree and classified as follow: +ve =normal power, -ve =motor weakness
Duration of sensory blockpostoperative 24 hoursblockade is defined as the interval between end of injection and complete end of sensory block (score=2)
Duration of motor blockpostoperative 24 hoursblockade is defined as the interval between end of injection and complete end of injection and complete recovery of normal motor function (score=0),
Pain measurement at restimmediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
heart ratepre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgeryChanges in heart rate
Mean arterial blood pressurepre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgeryChanges in Mean arterial blood pressure
Peripheral oxygen saturationpre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgeryChanges in peripheral oxygen saturation as measured with pulse oximetry
Time for first analgesic requestWithin 24 hours after surgerydefined as the time period from end of injection to the first time patient requests analgesia postoperatively
Total analgesics receivedfor 24 hrs after surgerycumulative consumption of opioids during the first postoperative day
PruritisWithin 24 hours after surgerynumber of patients with pruritis
nauseaWithin 24 hours after surgerynumber of patients with nausea
vomitingWithin 24 hours after surgerynumber of patients with vomiting
Anesthesiology satisfaction for patient positioningjust before surgeryevaluated as 0=unsatisfactory, 1=satisfactory, 2=good or 3=optimal

Countries

Egypt

Contacts

Primary ContactMona A Hasheesh, MD
drmonahasheesh@hotmail.com00201027034020
Backup ContactEiad A Ramzy, MD
eiadramzy@yahoo.com00201005774079

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026