Clinical trial NCT04285333: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture
Official title: Analgesic Techniques Before Spinal Anesthesia for Hip Fracture Repair: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Analgesia
Acute Pain
Keywords: hip fracture
nerve block
spinal anesthesia
analgesia
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
Collaborators: name: Institut Kassab d'Orthopédie
First posted: 2020-02-26
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised single blinded study
Primary purpose: TREATMENT

Brief summary: Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort.

Fascia Iliaca block (FIB) and Femoral nerve blocks are commonly used for analgesia in hip fracture patients. However, they often provide a modest reduction in pain.

The Percapsular Nerve Group block (PENG Block) has the advantage that it covers the accessory obturator nerve.

Aim of the study: compare FIB with PENG prior to positioning hip fracture patients for standardized SA.

In a prospective randomized double blind we included 80 patients aged more than 65 years old, for whom pain was felt when raising the affected limb to 15 degrees. Patients were assigned to receive either ultrasound guided Fascia Iliaca block or Percapsular Nerve Group block using 20 mL Lidocaine 1.5% in both groups. We compared pain on positioning for spinal anesthesia using Verbal Rating Scale (VRS 0 = no pain , VRS 1 = mild pain, t 2= severe pain) for both groups. We also recorded different times to perfom block.

Detailed description: The purpose of the study was to compare analgesis effect of Percapsula nerve group block to fascia iliaca block prior to positioning hip fracture patients for standardized SA. We included 80 patients reporting pain with Verbal Rating Scale at 2 when raising the affected limb to 15 degrees. All patients admitted to induction room, were given standard monitoring and we randomized to receive either: ultrasound fascia iliaca block using linear high frequency ultrasound probe (10-15MHz) placed in a transverse direction over the anterior thigh below the inguinal ligament. A 50 mm needle was advanced until the tips placed underneath the fascia iliaca and 20 mL 1.5% Lidocaine was injected or ultrasound Percapsula nerve group block A curvilinear using low-frequency ultrasound probe (2-5MHz) that was initially placed in a transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counter clockwise approximately 45 degrees. In this view, the iliopubic eminence , the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed and than a 100 mm needle was advanced to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly and 20 mL 1.5% Lidocaine.We compared pain on positioning for spinal anesthesia and also different time to realise both blocks.

Eligibility criteria: Inclusion Criteria:

* - Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA).
* Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2)

Exclusion Criteria:

* - ASA physical status ≥ 4.
* Impaired cognition or Dementia.
* Multiple fractures.
* Contraindication to regional anesthesia.
* Patient's disapproval.

Primary outcomes:
measure: positioning pain
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Positioning Rating
timeFrame: up to 40 minutes
measure: Imaging time
timeFrame: up to 10 minutes
measure: Puncture time
timeFrame: up to 10 minutes
measure: Performance time
timeFrame: up to 10 minutes
measure: Number of punctures
timeFrame: up to 10 minutes
measure: pain 5 after block
timeFrame: up to 5 minutes
measure: pain 10 after block
timeFrame: up to 10 minutes
measure: pain 15 after block
timeFrame: up to 15 minutes
measure: pain 20 after block
timeFrame: up to 20 minutes
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Institut Kassab D'Orthopedie
Study officials:
affiliation: Tunis El Manar University
name: khaireddine Raddaoui, MD
role: PRINCIPAL_INVESTIGATOR
References: