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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210700
• Other study ID #: 19MMHIS254e
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: June 4, 2023

Study information

• Verified date: March 2024
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 4, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Fractures, Bone
• Hip Fractures
• Nerve Blocks

Intervention

Procedure:
• Fascia 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.
• Pericapsular 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.

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (10)

Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154. — View Citation

Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available. — View Citation

Candal-Couto JJ, McVie JL, Haslam N, Innes AR, Rushmer J. Pre-operative analgesia for patients with femoral neck fractures using a modified fascia iliaca block technique. Injury. 2005 Apr;36(4):505-10. doi: 10.1016/j.injury.2004.10.015. — View Citation

Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184. — View Citation

Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543. — View Citation

Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133. — View Citation

Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. — View Citation

Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16. — View Citation

Steenberg J, Moller AM. Systematic review of the effects of fascia iliaca compartment block on hip fracture patients before operation. Br J Anaesth. 2018 Jun;120(6):1368-1380. doi: 10.1016/j.bja.2017.12.042. Epub 2018 Apr 5. — View Citation

Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurement at rest	Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest	30 minutes after nerve blocks
Primary	Pain measurement during internal rotation	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	30 minutes after nerve blocks
Secondary	Pain measurement at rest	Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest	10 minutes after nerve block
Secondary	Pain measurement during internal rotation	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	10 minutes after nerve block
Secondary	Pain measurement at rest	Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest	20 minutes after nerve block
Secondary	Pain measurement during internal rotation	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	20 minutes after nerve block
Secondary	pain measurement during positioning for spinal anesthesia	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	Just before operation
Secondary	pain measurement after operation	Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable)	6, 12, and 24 hours after operation
Secondary	the time spending for performing spinal anesthesia	defined as starting of positioning maneuver to removal of spinal needle	Just before operation
Secondary	quality of position for spinal anesthesia	characterized as unsatisfied, satisfied, good, and excellent by the anesthesiologists performing the spinal anesthesia	Just before operation
Secondary	the first time of pain perceived by the patient after operation	the time interval between the end of operation and pain first perceived by the patient	Within 48 hours after operation
Secondary	the time of first request for rescue analgesics after operation	the time interval between the end of operation and the first request for rescue analgesics	Within 48 hours after operation
Secondary	total consumption of rescue analgesics within 24 hours after the operation	total consumption of rescue analgesics within 24 hours after the operation	Within 24 hours after the operation
Secondary	the first time of ambulation after operation	the time interval between the end of operation and the first time the patient can ambulate with assistance after operation	Within 72 hours after operation
Secondary	the time spending for nerve block	defined as from contact of skin by the ultrasound transducer to removal of the needle	Before operation