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Neck of Femur FractureNCT05002725

PENG Versus Femoral Nerve Block in Neck of Femur Fracture

A study testing Lidocain in people with Neck of Femur Fracture, run by University College Cork at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Neck of Femur Fracture
What is being tested?
Lidocain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteIreland
Study dates
28 Jan 2021to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All patients scheduled for operative repair of hip fracture Patient age 16 years or more ASA I - III

Who cannot join

  • Patient refusal Coagulopathy Local infection Allergy to Local Anaesthetics Significant cognitive impairment (4AT score>=4) Weight <60kg

Trial locations and contacts

1 site in 1 country.

Brian D O'Donnell contact

0872780225

briodnl@gmail.com

Brian O'Donnell contact

0872780225

briodnl@gmail.com

Ireland1 site, 1 recruiting
  • Cork University Hospital

    Cork

    Brian D O'Donnell, 0872780225, briodnl@gmail.com

    Brian O'Donnell, 0872780225, briodnl@gmail.com

    Recruiting

Other trials in Ireland

About this study

Official title: A Comparison of Quadriceps Muscle Weakness Associated With PENG Blockade or Femoral Nerve Blockade for Patients Undergoing Neck of Femur (NOF) Fracture Surgery

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.

Read the detailed 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

Being tested
Lidocain
Medical subject headings
Femoral Neck Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocainDrug

    300mg (20ml) will be injected

Study groups in NCT05002725
Study groupRoleWhat they receive
PENGExperimentalAn ultrasound guided PENG catheter will be inserted. 20ml of 1.5% lidocaine will be administered.
Receives: Drug: Lidocain
Femoral BlockActive comparatorAn ultrasound guided Femoral Nerve catheter will be inserted. 20ml of 1.5% lidocaine will be administered.
Receives: Drug: Lidocain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quadriceps Motor Block

    Presence or absence of motor block

    Measured: 20 mins post procedure

Secondary outcomes (5)
  1. Pain

    VRS on passive hip flexion

    Measured: 20 mins post procedure

  2. 12 hr Pain

    VRS on passive hip flexion

    Measured: 20 mins post procedure

  3. 24 hr Pain

    VRS on passive hip flexion

    Measured: 20 mins post procedure

  4. Quadriceps Motor block

    Present or absent

    Measured: 24 hours post op

  5. cumulative opiate consumption

    Measured: 24 hours post op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start28 Jan 2021
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002725
Sponsor's protocol ID
UCCork 2021-BOD-1
Status last verified
Aug 2021
First submitted
4 Aug 2021
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Lidocain in people with Neck of Femur Fracture, run by University College Cork at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brian D O'Donnell (0872780225, briodnl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quadriceps Motor Block (time frame: 20 mins post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.

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