Clinical trial NCT04309539: Which Analgesia is Better for Proximal Femoral Fractures?
Official title: - Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proximal Femur Fracture
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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/m2.
* Multiple trauma patients.

Primary outcomes:
measure: Time of performance of Spinal Anesthesia
timeFrame: just before surgery.
Secondary outcomes:
measure: Pain measurement at rest
timeFrame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
measure: Pain measurement on movement
timeFrame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
measure: Pain measurement during positioning for spinal anesthesia
timeFrame: Just before surgery
measure: The severity of postoperative pain at rest
timeFrame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
measure: The severity of postoperative pain on movement
timeFrame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
measure: Time to onset of Sensory blockade
timeFrame: evaluated 15 and 30 min after block administration
measure: Time to onset of motor block
timeFrame: evaluated 15 and 30 min after block administration
measure: Duration of sensory block
timeFrame: postoperative 24 hours
measure: Duration of motor block
timeFrame: postoperative 24 hours
measure: Anesthesiology satisfaction for patient positioning
timeFrame: just before surgery
measure: heart rate
timeFrame: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
measure: Mean arterial blood pressure
timeFrame: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
measure: Peripheral oxygen saturation
timeFrame: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
measure: Time for first analgesic request
timeFrame: Within 24 hours after surgery
measure: Total analgesics received
timeFrame: for 24 hrs after surgery
measure: Pruritis
timeFrame: Within 24 hours after surgery
measure: nausea
timeFrame: Within 24 hours after surgery
measure: vomiting
timeFrame: Within 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, emergency hospital
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive care,,P
name: Mona A Hasheesh, MD
role: STUDY_CHAIR
affiliation: Associate Professor of Anesthesia and Surgical Intensive care,
name: Eiad A Ramzy, MD
role: STUDY_DIRECTOR
References: