Hip Fractures, Analgesia, Nerve Blocks
Conditions
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.
Interventions
PROCEDUREFascia iliaca compartment block
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.
PROCEDUREPericapsular nerve group block
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.
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain measurement at rest | 30 minutes after nerve blocks | Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest |
| Pain measurement during internal rotation | 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
| Measure | Time frame | Description |
|---|---|---|
| pain measurement during positioning for spinal anesthesia | 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 |
| pain measurement after operation | 6, 12, and 24 hours after operation | Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) |
| the time spending for performing spinal anesthesia | Just before operation | defined as starting of positioning maneuver to removal of spinal needle |
| quality of position for spinal anesthesia | Just before operation | characterized as unsatisfied, satisfied, good, and excellent by the anesthesiologists performing the spinal anesthesia |
| Pain measurement at rest | 10 minutes after nerve block | Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest |
| the time of first request for rescue analgesics after operation | Within 48 hours after operation | the time interval between the end of operation and the first request for rescue analgesics |
| total consumption of rescue analgesics within 24 hours after the operation | Within 24 hours after the operation | total consumption of rescue analgesics within 24 hours after the operation |
| the first time of ambulation after operation | 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 |
| the time spending for nerve block | Before operation | defined as from contact of skin by the ultrasound transducer to removal of the needle |
| the first time of pain perceived by the patient after operation | Within 48 hours after operation | the time interval between the end of operation and pain first perceived by the patient |
| Pain measurement during internal rotation | 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 |
Countries
Taiwan
Outcome results
None listed