The aim of this study is to compare the efficacy and safety of preoperatively placed Pericapsular Nerve Group block (PENG), Fascia-Iliaca Compartment Block (FICB) and Femoral Nerve Block (FNB) for patients with hip fractures in the ED.
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Score on the patient-reported QoR-15 questionnaire.
Secondary outcome
o Pre-operative pain scores at 15 min-, 30 min-, and 1 hour post-block
placement.
o The amount of rescue medication calculated as mg/hour given IV in the ED
after block placement or SC/IO in the ward during the first 12 hours after
block placement or until operation.
o Number and type of adverse and serious adverse events.
Background summary
An aging population will result in a growing prevalence of hip fractures. Hip
fractures pose an increased risk of mortality, morbidity, and functional
impairment.
Adequate perioperative pain reduction is of utmost importance as pain is an
important factor influencing complication rates, posing a significant risk for
decreased functional outcomes. Systemic analgesia is commonly used in the pain
management of patients with hip fractures, including opioids (e.g. morphine or
fentanyl). However, opioids are associated with adverse events. An alternative
method to obtain adequate analgesia is the use of regional nerve blocks. Nerve
blocks have several advantages over systemic analgesia. First, they may provide
superior analgesia. Second, they contribute to a reduction in opioid use and
opioid-related adverse events. Recent guidelines therefore advise to use
regional anaesthetic techniques for pain management in hip fractures.
Currently, there are three different types of nerve blocks for pain management
for hip fractures: Femoral Nerve Block, Fascia-Iliaca Compartment Block en
Pericapsular Nerve Group Block. So far, literature directly comparing the
different options to provide regional anaesthesia after a hip fracture is
scarce, and not focussed on early administration of nerve blocks in the
emergency department (ED).
Study objective
The aim of this study is to compare the efficacy and safety of preoperatively
placed Pericapsular Nerve Group block (PENG), Fascia-Iliaca Compartment Block
(FICB) and Femoral Nerve Block (FNB) for patients with hip fractures in the ED.
Study design
This study is a Randomized Controlled Trial (RCT).
Intervention
Participants will receive either FNB, FICB or PENG block.
Study burden and risks
Although PENG, FICB and FNB are overall safe when performed correctly, there
are some risks associated with these procedures. These risks include: bleeding
(1-2% chance), infection, damage to surrounding structures, (permanent) nerve
injury, and intravascular uptake of local anesthetic resulting in systemic
toxicity (LAST). In addition, there is a 5-10% chance that the block provides
suboptimal analgesia with the need for additional analgesics. Important to note
is that PENG, FICB and FNB are all standard care in the ED. However, since all
included types of regional anesthesia in the setting of traumatic femur
fractures are part of well-established clinical practice, there is no
additional risk for the patients participating in this study.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older.
- proximal- or neck of femur fracture requiring surgical intervention.
- Able and willing to provide informed consent and reliably report symptoms to
the research team.
Exclusion criteria
- Known allergy to local anaesthetics.
- Infection at the injection-site.
- Periprosthetic fracture.
- Skin injury, local infection or recent burns hindering the use of ultrasound
for ultrasound guided nerve block placement.
- Multiple fractures simultaneously.
- Pain score of < 2 (range 0 - 10) or < 20 (range 0 - 100) in rest or when
moving in bed, when presented to the ED.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87859.099.24 |