Clinical trial NCT04210700: Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control
Official title: Comparing Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block for Hip Fracture Pain Control Before Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Analgesia
Nerve Blocks
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain measurement at rest
timeFrame: 30 minutes after nerve blocks
measure: Pain measurement during internal rotation
timeFrame: 30 minutes after nerve blocks
Secondary outcomes:
measure: Pain measurement at rest
timeFrame: 10 minutes after nerve block
measure: Pain measurement during internal rotation
timeFrame: 10 minutes after nerve block
measure: Pain measurement at rest
timeFrame: 20 minutes after nerve block
measure: Pain measurement during internal rotation
timeFrame: 20 minutes after nerve block
measure: pain measurement during positioning for spinal anesthesia
timeFrame: Just before operation
measure: pain measurement after operation
timeFrame: 6, 12, and 24 hours after operation
measure: the time spending for performing spinal anesthesia
timeFrame: Just before operation
measure: quality of position for spinal anesthesia
timeFrame: Just before operation
measure: the first time of pain perceived by the patient after operation
timeFrame: Within 48 hours after operation
measure: the time of first request for rescue analgesics after operation
timeFrame: Within 48 hours after operation
measure: total consumption of rescue analgesics within 24 hours after the operation
timeFrame: Within 24 hours after the operation
measure: the first time of ambulation after operation
timeFrame: Within 72 hours after operation
measure: the time spending for nerve block
timeFrame: Before operation
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Sheng-Chin Kao, MD
role: PRINCIPAL_INVESTIGATOR
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