Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05002725 |
| Other study ID # |
UCCork 2021-BOD-1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 28, 2021 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
University College Cork |
| Contact |
Brian D O'Donnell |
| Phone |
0872780225 |
| Email |
briodnl[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Neck of femur (NOF) fracture is a common presentation to the emergency department,
particularly in our older population. NOF fracture is associated with a high social and
economic cost with significant effects on patients' quality of life. Analgesia and ambulation
are important determinants of outcome following NOF surgery. We propose to compare whether
PENG or Femoral Nerve Block is associated with a greater degree of quadriceps motor
dysfunction.
Description:
Neck of femur (NOF) fracture is a common presentation to the emergency department,
particularly in our older population.1.NOF fracture is associated with a high social and
economic cost with significant effects on patients' quality of life
The latest Irish Hip Fracture Database (IHFD) report from 2019 detailed 3,701 NOF fractures
in patients over 60 years of age in Ireland and 437 of these patients attended CUH.2 This
frail and vulnerable group had an average age of 81 and many people suffered numerous
co-morbid conditions. 3 This population of patients is therefore at significant risk of
complications and require multidisciplinary input to optimise clinical outcome
From a patient's perspective, NOF fracture is a very painful condition, requiring early
surgical fixation. It is associated with significant morbidity and mortality. In 2019, 5% of
patients who sustained a hip fracture in Ireland died, an additional 4% of patients required
new admission to a nursing home following this fracture and a further 13% required
convalescent care3
These patients are also particularly at risk for under-treatment of pain. Contraindications
to many commonly used analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs) exist
in this population, including renal dysfunction in 40%5. Older adults suffer more adverse
effects from opiate analgesia such as nausea, vomiting, constipation, drowsiness and
respiratory complications. This population also have a 25% incidence of cognitive impairment
which may make communication and assessment of their pain more challenging. 1, 3
Under-treated pain also confers a 9 fold increased risk of delirium in cognitively intact
patients14
Peripheral nerve blocks (PNB) have been extensively researched in this group of patients with
a view to improving the quality of pain relief while reducing the side effects of analgesic
medications used. In 2017, a Cochrane review on PNB in the management of patients with NOF
fractures concluded that there was high quality evidence that PNB reduces pain on movement
within 30 minutes after block placement and reduces opioid consumption and moderate quality
evidence that PNB reduces the incidence of pneumonia, time to first mobilization and cost. 6
Widespread use of PNB on admission to hospital and in the early postoperative period is also
supported by the latest Association of Anaesthetists' (AoA) guideline: "Guideline for the
management of hip fractures 2020". In this, they recommend using femoral or fascia iliaca
blocks as pericapsular nerve group (PENG) blocks have not yet been compared with these more
established blocks in trials. They also recommend that general anaesthesia or spinal
anaesthesia should be routinely supplemented with PNB and state that there is little evidence
at present for continuous catheter techniques which may delay remobilisation5
Issues with current practice:
Often patients with NOF fractures endure significant pain during their hospitalisation. The
proportion of patients receiving PNB varies nationally from 10-95% depending on hospital. The
AoA recommend that PNB should be undertaken in the Emergency department and at the time of
surgery provided 6 hours have passed.5 Under-treated pain has been demonstrated to increase
the risk of delirium in cognitively intact patients with NOF fractures with a relative risk
of 9.014 It is also likely to lead to significant patient dissatisfaction Single injection
PNB blocks are limited by short duration a fact that can be mitigated by continuous catheter
techniques. A study from our institution published in 2012 demonstrated more effective
perioperative analgesia, reduced opiate consumption and improved patient satisfaction when
continuous femoral nerve blockade was compared with a standard opiate based regime in
patients with NOF fractures.7 However, femoral nerve blockade can be associated with weakness
of the quadriceps muscle, possibly reducing early postoperative mobility and increasing the
risk of falls. A study of healthy volunteers demonstrated a significant reduction in
quadriceps strength and balance scores following femoral nerve blockade8 Another study
suggested a causal relationship between continuous peripheral nerve blocks and falls after
hip and knee arthroplasty 9
Proposal of novel intervention We propose performing a PENG block for postoperative
analgesia. The pericapsular nerve group (PENG) block, first described in 2018, is a PNB
technique which aims to provide analgesia for patients with NOF fractures by blocking sensory
branches of the femoral nerve, obturator nerve and accessory obturator nerve to the anterior
hip capsule.10
Justification in support of the intervention The PENG block aims to block the articular
branches of the femoral, obturator and accessory obturator nerves which supply the hip
joint.10 Tran et al demonstrated spread to all three nerves using the PENG block
technique.11This is theoretically a more comprehensive blockade of the pain fibres from the
hip than would be achieved with a traditional femoral nerve block. Therefore the analgesia
achieved may be superior than with other blocks. Published case reports and case series
suggest PENG block efficacy.13
The PENG block aims to block the sensory articular branches while sparing the motor
innervation of the quadriceps muscle. This is likely to result in less quadriceps muscle
weakness which in turn can affect balance and may cause contribute to falls
postoperatively.8,9
The AoA do not recommend continuous catheter techniques in their latest guideline due to a
lack of evidence and the potential contribution of quadriceps weakness to falls.5 If the PENG
block does not cause quadriceps weakness and has the potential to provide superior analgesia,
this is likely to improve a patient's ability to mobilise early postoperatively and engage
with physiotherapy and rehabilitation. This may improve outcomes. Continuous catheter
techniques (most commonly PENG catheters) are currently used in our institution for
postoperative analgesia
