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Clinical Trials/NCT04309539
NCT04309539
Unknown
Not Applicable

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

Mansoura University1 site in 1 country100 target enrollmentSeptember 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Femur Fracture
Sponsor
Mansoura University
Enrollment
100
Locations
1
Primary Endpoint
Time of performance of Spinal Anesthesia
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2020
End Date
March 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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/m

Outcomes

Primary Outcomes

Time of performance of Spinal Anesthesia

Time Frame: just before surgery.

Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection

Secondary Outcomes

  • 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.)
  • 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.)
  • Duration of sensory block(postoperative 24 hours)
  • heart rate(pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery)
  • 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)
  • Time to onset of Sensory blockade(evaluated 15 and 30 min after block administration)
  • Time to onset of motor block(evaluated 15 and 30 min after block administration)
  • Duration of motor block(postoperative 24 hours)
  • Pain measurement during positioning for spinal anesthesia(Just before surgery)
  • Pruritis(Within 24 hours after surgery)
  • vomiting(Within 24 hours after surgery)
  • 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.)
  • 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.)
  • Total analgesics received(for 24 hrs after surgery)
  • nausea(Within 24 hours after surgery)
  • Anesthesiology satisfaction for patient positioning(just before surgery)
  • Peripheral oxygen saturation(pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery)
  • Time for first analgesic request(Within 24 hours after surgery)

Study Sites (1)

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