Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture

NCT04285333 | Completed

• 1 other identifier: CE-IMKO 102/2019
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fracture; Analgesia; Acute Pain

Keywords

hip fracture; nerve block; spinal anesthesia; analgesia

Outcome Measures

Primary Outcomes (1)

• positioning pain

  Verbal Rating Scale (VRS) \[0=no pain ; 4=worst pain\]

  up to 30 minutes

Secondary Outcomes (9)

• Positioning Rating

  up to 40 minutes

• Imaging time

  up to 10 minutes

• Puncture time

  up to 10 minutes

• Performance time

  up to 10 minutes

• Number of punctures

  up to 10 minutes

Study Arms (2)

fascial iliaca

ACTIVE COMPARATOR

: A linear high frequency ultrasound probe (10-15MHz) was placed in a transverse direction over the anterior thigh below the inguinal ligament. We identified the femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca. The needle was inserted in plane and a 22 gauge, 50 mm needle was advanced until the tips placed underneath the fascia iliaca. Following negative aspiration, the local anesthetic solution was injected in 5mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine

Procedure: fascia iliaca block

Percapsular nerve group block

EXPERIMENTAL

A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine.

Procedure: percapsular nerve group block

Interventions

fascia iliaca block PROCEDURE

ultrasound guided block with 20 mL lidocaine 1.5%

Also known as: BIF for hip fracture

fascial iliaca

percapsular nerve group block PROCEDURE

ultrasound guided block with 20 mL lidocaine 1.5%

Also known as: PENG block for hip fracture

Percapsular nerve group block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Tunis El Manar: lead
• Institut Kassab d'Orthopédie: collaborator

Study Sites (1)

Institut Kassab D'Orthopedie

Tunis, 2010, Tunisia

Location

MeSH Terms

Conditions

Hip Fractures; Agnosia; Acute Pain

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• khaireddine Raddaoui, MD

  Tunis El Manar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: all blocks were performed in a special area outside operating room by docters only implicated in performance assessement of block and not in patient care. Patients where after moved to operating room, care provider wil assess pain before spinal anesthesia
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective randomised single blinded study

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 26, 2020
• Study Start: March 17, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 31, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)