Which Analgesia is Better for Proximal Femoral Fractures?

Not Applicable

• Conditions: Proximal Femur Fracture
• Interventions: Procedure: combined LFCN block with PENG block; Procedure: Fascia iliaca block

• Registration Number: NCT04309539
• Lead Sponsor: Mansoura University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-16
• Status Verified: 2020-09
• Study Start: 2020-09-21
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-23
• Primary Completion: 2021-06
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined LFCN block with PENG block	combined LFCN block with PENG block	Patients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block
Fascia iliaca block	Fascia iliaca block	Patients will receive Fascia iliaca block

Primary Outcome Measures

Name	Time	Method
Time of performance of Spinal Anesthesia	just before surgery.	Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection

Secondary Outcome Measures

Name	Time	Method
Pruritis	Within 24 hours after surgery	number of patients with pruritis
Pain measurement at rest	immediately 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
Pain measurement on movement	immediately 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
Duration of sensory block	postoperative 24 hours	blockade is defined as the interval between end of injection and complete end of sensory block (score=2)
heart rate	pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery	Changes in heart rate
Mean arterial blood pressure	pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery	Changes in Mean arterial blood pressure
Time to onset of Sensory blockade	evaluated 15 and 30 min after block administration	cold 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 block	evaluated 15 and 30 min after block administration	defined 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 motor block	postoperative 24 hours	blockade 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 during positioning for spinal anesthesia	Just before surgery	visual analog scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to sitting one
vomiting	Within 24 hours after surgery	number of patients with vomiting
The severity of postoperative pain at rest	immediately 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 movement	immediately 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
Total analgesics received	for 24 hrs after surgery	cumulative consumption of opioids during the first postoperative day
nausea	Within 24 hours after surgery	number of patients with nausea
Anesthesiology satisfaction for patient positioning	just before surgery	evaluated as 0=unsatisfactory, 1=satisfactory, 2=good or 3=optimal
Peripheral oxygen saturation	pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery	Changes in peripheral oxygen saturation as measured with pulse oximetry
Time for first analgesic request	Within 24 hours after surgery	defined as the time period from end of injection to the first time patient requests analgesia postoperatively

Trial Locations

Locations (1)

Mansoura University, emergency hospital; 🇪🇬 Mansourah, DK, Egypt