Skip to main content
OpenTrials
Completed

NCT Number: NCT04210700

Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control

The aim of the study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control. The participants, caregivers, and assessors will be blinded to the type of block the participants receive. Patients aged 20 years or older with hip fracture scheduled for surgical treatment will be assessed for eligibility to participate the study. One hundred eligible patients will be included in the study after informed consents are obtained, and then randomly allocated into either FIC block or PENG block, with 50 patients in each group. Both blocks will performed under ultrasound guidance.

The followings will be assessed: the numerical rating pain scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) at before and after nerve block at different time points during rest and passive internal rotation of the fractured lower limb to neutral position from its typical external rotation deformity 30 mins after block (primary outcome). The degree of patient's satisfaction regarding nerve blocks and anesthesiologist's satisfaction regarding patient position during spinal anesthesia will also be assessed. The pain and use of rescue analgesics in the first 24 hours after operation will be recorded.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Fractures Agnosia Analgesia Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Nerve Blocks Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackay Memorial Hospital

New Taipei City, 25160, Taiwan

About this study

The aim of this study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control before operation.

Methods This will be a randomized, assessor and participant-blinded study. After the patients give his /her informed consents, his/her baseline demographic data (gender, age, height, and body weight) and types of hip fracture will be recorded. Participants will be randomly allocated into either FIC block or PENG block by using the website RESEARCH RANDOMIZER (https://www.randomizer.org). One of the two anesthesiologists experienced in performed the FIC and PENG blocks will perform the nerve blocks. Only the anesthesiologist performing the nerve block and his assistant will be aware of which nerve block the participant receives immediately before performing nerve block by opening a sealed envelope. The assessors, in-charge anesthesiologists and nurse anesthetists, operation room personnel, surgeons and study participants will be all blinded to the randomization.

On arrival of the operating theater, all participants will be sent to the nerve block area, where continuous electrocardiogram, pulse oximetry, and non-invasive intermittent blood pressure monitoring will be applied and an intravenous line will be established. Before any intervention, pain at rest and during the fractured lower limb being passively internal rotated in extension to neutral position from its usual externally rotated deformity by assessors will assessed using NRS. If the participant cannot tolerate passive internal rotation of his/her fractured limb due to pain, impossibility to perform the test will be recorded as well as the worst NRS score during these attempts. The same assessment will be performed every 10 mins for until 30 mins after completion of the nerve block. Then the patient will be sent to the operation room, where spinal anesthesia will be performed for the surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for surgical treatment for hip fracture
  • American Society of Anesthesiologists (ASA) physical status I-III

Exclusion criteria

  • allergy to local anesthetics
  • pregnancy
  • inability to understand and use the numerical rating scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) after instruction
  • chronic use of opioids
  • coagulopathy
  • neuropathy
  • severe diabetic mellitus

Treatment and study plan

Fascia iliaca compartment block

Procedure

A linear ultrasound transducer is placed in a sagittal plane to identify the anterior superior iliac spine. By sliding the transducer medially, the fascia iliaca and abdominal internal oblique, sartorius, and iliopsoas muscles are identified. After identifying the "bow-tie sign", a 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from caudal to cephalad until the needle tip penetrate the fascia iliaca. After negative aspiration, 0.35% ropivacaine 30mL with 1:400,000 epinephrine will be injected to separate the fascia iliaca and the iliacus muscle.

pericapsular nerve group block

Procedure

A curvilinear ultrasound transducer is initially place on the anterior inferior iliac spine and then aligned to the iliopubic eminence by rotating around 45 degree. In this view, the iliopubic eminence, iliapsoas muscle and tendon, pectineus muscle, femoral artery and vein will be identified. A 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from lateral to medial until the needle tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. After negative aspiration, 0.35% ropivacaine 20mL with 1:400,000 epinephrine will be injected.

Primary outcomes

  1. Pain measurement at rest

    Time frame: 30 minutes after nerve blocks

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest

  2. Pain measurement during internal rotation

    Time frame: 30 minutes after nerve blocks

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity

Secondary outcomes

  1. Pain measurement at rest

    Time frame: 10 minutes after nerve block

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest

  2. Pain measurement during internal rotation

    Time frame: 10 minutes after nerve block

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity

  3. Pain measurement at rest

    Time frame: 20 minutes after nerve block

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest

  4. Pain measurement during internal rotation

    Time frame: 20 minutes after nerve block

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity

  5. pain measurement during positioning for spinal anesthesia

    Time frame: Just before operation

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to lateral decubitus with flexion of the healthy hip

  6. pain measurement after operation

    Time frame: 6, 12, and 24 hours after operation

    Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable)

  7. the time spending for performing spinal anesthesia

    Time frame: Just before operation

    defined as starting of positioning maneuver to removal of spinal needle

  8. quality of position for spinal anesthesia

    Time frame: Just before operation

    characterized as unsatisfied, satisfied, good, and excellent by the anesthesiologists performing the spinal anesthesia

  9. the first time of pain perceived by the patient after operation

    Time frame: Within 48 hours after operation

    the time interval between the end of operation and pain first perceived by the patient

  10. the time of first request for rescue analgesics after operation

    Time frame: Within 48 hours after operation

    the time interval between the end of operation and the first request for rescue analgesics

  11. total consumption of rescue analgesics within 24 hours after the operation

    Time frame: Within 24 hours after the operation

    total consumption of rescue analgesics within 24 hours after the operation

  12. the first time of ambulation after operation

    Time frame: Within 72 hours after operation

    the time interval between the end of operation and the first time the patient can ambulate with assistance after operation

  13. the time spending for nerve block

    Time frame: Before operation

    defined as from contact of skin by the ultrasound transducer to removal of the needle

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

Comparing Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block for Hip Fracture Pain Control Before Operation

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2019
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.