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

Analgesia Clinical Trial

Official title:

Analgesic Techniques Before Spinal Anesthesia for Hip Fracture Repair: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285333
• Other study ID #: CE-IMKO 102/2019
• Status: Completed
• Phase: N/A
• Start date: March 17, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2024
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• fascia iliaca block
ultrasound guided block with 20 mL lidocaine 1.5%
• percapsular nerve group block
ultrasound guided block with 20 mL lidocaine 1.5%

Locations

Country	Name	City	State
Tunisia	Institut Kassab D'Orthopedie	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
University Tunis El Manar	Institut Kassab d'Orthopédie

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positioning pain	Verbal Rating Scale (VRS) [0=no pain ; 4=worst pain]	up to 30 minutes
Secondary	Positioning Rating	verbal rating scale (VRS) [0=no pain ; 4=worst pain]	up to 40 minutes
Secondary	Imaging time	For the PENG block:the femoral artery, the anterior inferior iliac spine, the iliopubic eminence and the psoas tendon.; For the FIB: the femoral artery, the iliacus muscle, the fascia iliaca and the fascia lata.	up to 10 minutes
Secondary	Puncture time	the time that stretches from the introduction of the needle until the end of the injection of local anesthetic	up to 10 minutes
Secondary	Performance time	the imaging time + time to puncture.	up to 10 minutes
Secondary	Number of punctures	the number of redirection of the needle after removing 2 cm.	up to 10 minutes
Secondary	pain 5 after block	verbal rating scale (VRS) [0=no pain ; 4=worst pain]	up to 5 minutes
Secondary	pain 10 after block	verbal rating scale (VRS) [0=no pain ; 4=worst pain]	up to 10 minutes
Secondary	pain 15 after block	verbal rating scale (VRS) [0=no pain ; 4=worst pain]	up to 15 minutes
Secondary	pain 20 after block	verbal rating scale (VRS) [0=no pain ; 4=worst pain]	up to 20 minutes