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Hip FracturesNCT05095025

PENG: an Estimation of ED50 in Neck of Femur Fracture

A study testing Bupivacaine Hydrochloride 20ml injectate in people with Hip Fractures and Pain, Acute, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The effective dose of local anaesthetic used in PENG blocks to achieve analgesia in patients with fractured neck of femur is unknown. It is planned to address this question using a dixon/massey sequential dosing methodology to establish the ED50 of 0.25% Bupivacaine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Fractures, Pain, Acute
What is being tested?
Bupivacaine Hydrochloride 20ml injectate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIreland
Study dates
14 Sep 2021to 1 Oct 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients scheduled for operative repair of hip fracture
  • Patient age 18 years or more
  • ASA I - III

Who cannot join

  • Patient refusal
  • Coagulopathy
  • Local infection
  • Allergy to Local Anaesthetics
  • Significant cognitive impairment (4AT score>=4 or otherwise unable to provide consent)
  • Previous RA procedure within 24hours with ongoing analgesia
  • Weight <50kg

Trial locations and contacts

1 site in 1 country.

Brian D O'Donnell, MD contact

+353872780225

briodnl@gmail.com

Aohgan O'Muirheartaigh, MD contact

md ext. md

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: PENG Block for Patients Undergoing Neck of Femur (NOF) Fracture Surgery: a Dose Finding Study

The effective dose of local anaesthetic used in PENG blocks to achieve analgesia in patients with fractured neck of femur is unknown. It is planned to address this question using a dixon/massey sequential dosing methodology to establish the ED50 of 0.25% Bupivacaine.

Read the detailed description

Neck of femur (NOF) fracture is a common presentation to the emergency department, particularly in the older population. 77,210 NOF fractures were recorded in the UK and Ireland in 2018 and the number of cases is projected to increase as life expectancy improves. NOF fracture is associated with a high social and economic cost, estimated to cost €45 million annually in Ireland 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. These patients occupied 72,314 acute hospital bed days nationally and 437 of these patients attended CUH. This frail and vulnerable group had an average age of 81 and many people suffered numerous co-morbid conditions. 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. The 30-day mortality for this condition has improved recently. This has likely multifactorial, in part due to the introduction of clinical guidelines, national audits, a focus on processes and changes in how hip fracture care is funded. However, 5% of patients who sustained a hip fracture in Ireland in 2019 died. An additional 4% of patients required new admission to a nursing home following this fracture and a further 13% required convalescent care.

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%. 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.

Regional anaesthesia (RA) has 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 RA in the management of patients with NOF fractures concluded that there was high quality evidence that RA reduces pain on movement within 30 minutes after block placement and reduces opioid consumption and moderate quality evidence that RA reduces the incidence of pneumonia, time to first mobilization and cost.

Widespread use of RA 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, femoral or fascia iliaca blocks are recommended as pericapsular nerve group (PENG) blocks have not yet been compared with these more established blocks in trials. It is also recommend that general anaesthesia or spinal anaesthesia should be routinely supplemented with RA and state that there is little evidence at present for continuous catheter techniques which may delay remobilisation.

Single injection RA blocks are limited by their short duration which can be prolonged by continuous catheter techniques. A study from Cork University Hospital 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 for up to 54 hours on passive movement and up to 42 hours at rest. 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 blockade. Another study suggested a causal relationship between continuous peripheral nerve blocks and falls after hip and knee arthroplasty.

The pericapsular nerve group (PENG) block, first described in 2018, is a RA 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. This may improve analgesia to the NOF fracture site compared with femoral nerve blockade, while sparing the branches of the femoral nerve which supply motor innervation to the quadriceps muscle, thereby lessening muscle weakness. A published dissection of an embalmed cadaver injected with 10ml and 20ml of dye via PENG block demonstrated that both volumes spread to the articular branches of the femoral, obturator and accessory obturator nerves but there is no published data in patients.

Continuous catheter techniques have also been described for this block.

This study aims to measure the dose of bupivacaine required to provide adequate analgesia at 30 minutes. As described above, there is a lack of available data on the effective dose. Given the proposed mechanism and the demonstrated spread of local anaesthetic injected via PENG block, as well as published results from case series, it is plausible that PENG blocks produce superior analgesia to the currently used femoral blocks and fascia iliaca blocks. For similar reasons, PENG blocks are likely associated with significantly less leg weakness compared with femoral nerve blocks; there are 2 reported cases in the published literature, both attributed to inadvertent femoral block. Finally, the latest AoA guidelines cite a lack of evidence and delayed remobilization as reasons against using continuous catheter techniques. Lack of motor weakness is a proposed benefit of this block and the possibility of improved pain relief postoperatively is likely to enhance a patient's remobilisation, increasing the importance of this study.

Being tested
Bupivacaine Hydrochloride 20ml injectate
Keywords
bupivacaine, dose, PENG Block, Regional Anesthesia
Medical subject headings
Hip Fractures, Acute Pain

What participants receive

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

  • Bupivacaine Hydrochloride 20ml injectateDrug

    Also called Sequential up and down dosing

    Sequential dosing, starting at 50mg with 5mg increments based on the outcome of the preceding participant

Study groups in NCT05095025
Study groupRoleWhat they receive
Bupivacaine dose findingExperimentalSequential up and down dose modification based on the outcome of the intervention in the preceding participant
Receives: Drug: Bupivacaine Hydrochloride 20ml injectate

What is being measured

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

  1. Analgesic success

    Verbal rated pain score of ≤3/10 30 minutes after the administration of a predetermined dose of bupivacaine via a continuous PENG catheter

    Measured: 30 minutes

Secondary outcomes (1)
  1. Analgesic failure

    Verbal rated pain score of ≥ 3/10 30 minutes after the administration of a predetermined dose of bupivacaine via a continuous PENG catheter

    Measured: 30 minutes

Timeline

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

  1. First posted27 Oct 2021
  2. Study start14 Sep 2021
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Oct 2022 (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
Not applicable
Intervention model
Sequential
Model description
Using a sequential step-up, step-down dosing model the dose of bupivacaine administered will be determined by the response of the preceding patient. Each participant will receive a total injectate volume of 20ml. Based upon the published efficacy literature, the starting dose of bupivacaine will be 50mg. The dose of bupivacaine will be adjusted by 5mg up or down based on the outcome (analgesic success or failure) of each subsequent participant.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05095025
Sponsor's protocol ID
PENG Dose 1
Status last verified
Oct 2021
First submitted
20 Sep 2021
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine Hydrochloride 20ml injectate in people with Hip Fractures and Pain, Acute, 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 3 inclusion and 7 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 27 Oct 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, MD (+353872780225, briodnl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analgesic success (time frame: 30 minutes). 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 27 Oct 2021.

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