Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia?
NCT ID: NCT06212622
Last Updated: 2024-12-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
64 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-03-04
Study Completion Date
2024-07-18
Brief Summary
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Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Studies have shown that in hip fracture surgery, early mobilisation confers better pain control, 30-day complication and mortality rates and could reduce in hospital length of stay.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain.
In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Alfentanil is a relatively new medication which has a very rapid onset of action and short half life. Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery. This study could provide robust evidence for regular use of alfentanil prior to physiotherapy in early post operative hip fracture surgery patients.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain.
In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Alfentanil is a relatively new medication which has a very rapid onset of action and short half life. Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery. This study could provide robust evidence for regular use of alfentanil prior to physiotherapy in early post operative hip fracture surgery patients.
Detailed Description
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Hip fractures are amongst the most common orthopaedic injuries. These fractures predominantly occur in the elderly population, secondary to osteoporosis. Projection studies from across the world suggest that incidence rates of hip fractures are set to increase. Worldwide projections indicate that hip fracture cases will double from 1.26 million in 1990, to 2.6 million by 2025, and to 4.5 million by 2050. The National Joint Registry reports that the number of hip fractures have increased from 1,371 in 2010 to 84,998 in 2021 across England, Wales and Northern Ireland. The Scottish Hip Fracture Audit identifies an increase from 6,369 hip fracture cases in 2007 to 8,380 in 2022. Given the exponential rise in the frail elderly population, these numbers will only further rise in the future.
Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Moreover, there is significant social and economic costs on the healthcare system stemming from these injuries. In the United States, these costs are greater than $5.96 billion, annually. In the United Kingdom, these costs are approximately £1.1 billion. Healthcare systems globally, are becoming progressively more financially restrained, and the incidence of hip fractures are set to increase. Thus, further emphasis should be placed on interventions to reduce morbidity and mortality in this frail elderly patient group.
Many studies have shown that early mobilisation after hip fracture surgery provides reduced post operative pain and complication rates and reduces length of stay (LOS) in hospital. Some studies have demonstrated that early ambulation reduces 30-day mortality rates in this patient population. It has been demonstrated that early mobilisation was also associated with an increased rate of discharges directly home, compared to those patients who mobilised late. Although elderly patients have associated co-morbidity and a higher risk of delirium, neither factors influenced inability to mobilise early after surgery. They also found that a greater number of patients who mobilised early were able to be discharged directly home.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain. Studies report that pain is often a key obstacle to early ambulation after surgery. In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Oxycodone has been utilised in clinical practice since 1917. There is in depth literature on the pharmacokinetics of oxycodone. The onset of action of oral oxycodone is between 10-30 minutes. Peak onset occurs around 1 hour. Plasma half-life is 3-5 hours, regardless of route of administration.
On the other hand, alfentanil is relatively new, and the literature is scarce on its pharmacokinetic properties. There is consensus amongst the literature that onset of action of alfentanil is very rapid, with peak onset of intravenous alfentanil as quick as 2 minutes. Plasma half-life of oral alfentanil is 1-2 hours. Moreover, side effects of respiratory depression are lower than that from fentanyl or sufentanil. The combination of rapid onset of pain relief, with an equally quick excretion, makes this medication appealing in palliative care medicine, in which patients are typically frail. This is particularly the case in patients with renal impairment since this medication is excreted by the liver.
Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery.
Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Moreover, there is significant social and economic costs on the healthcare system stemming from these injuries. In the United States, these costs are greater than $5.96 billion, annually. In the United Kingdom, these costs are approximately £1.1 billion. Healthcare systems globally, are becoming progressively more financially restrained, and the incidence of hip fractures are set to increase. Thus, further emphasis should be placed on interventions to reduce morbidity and mortality in this frail elderly patient group.
Many studies have shown that early mobilisation after hip fracture surgery provides reduced post operative pain and complication rates and reduces length of stay (LOS) in hospital. Some studies have demonstrated that early ambulation reduces 30-day mortality rates in this patient population. It has been demonstrated that early mobilisation was also associated with an increased rate of discharges directly home, compared to those patients who mobilised late. Although elderly patients have associated co-morbidity and a higher risk of delirium, neither factors influenced inability to mobilise early after surgery. They also found that a greater number of patients who mobilised early were able to be discharged directly home.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain. Studies report that pain is often a key obstacle to early ambulation after surgery. In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Oxycodone has been utilised in clinical practice since 1917. There is in depth literature on the pharmacokinetics of oxycodone. The onset of action of oral oxycodone is between 10-30 minutes. Peak onset occurs around 1 hour. Plasma half-life is 3-5 hours, regardless of route of administration.
On the other hand, alfentanil is relatively new, and the literature is scarce on its pharmacokinetic properties. There is consensus amongst the literature that onset of action of alfentanil is very rapid, with peak onset of intravenous alfentanil as quick as 2 minutes. Plasma half-life of oral alfentanil is 1-2 hours. Moreover, side effects of respiratory depression are lower than that from fentanyl or sufentanil. The combination of rapid onset of pain relief, with an equally quick excretion, makes this medication appealing in palliative care medicine, in which patients are typically frail. This is particularly the case in patients with renal impairment since this medication is excreted by the liver.
Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery.
Conditions
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Hip Injuries
Hip Fractures
Pain
Post Operative Pain
Early Ambulation
Keywords
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early mobilisation
hip fracture
pain
oxycodone
alfentanil
ambulation
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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STANDARD CARE WITH ORAL OXYCODONE
These patients will receive oral oxycodone prior to their post operative day 1 and 2 physiotherapy sessions
The dose is age dependent (and also on frailty status):
\< 65 years old: Oxycodone 5mg immediate release
65 - 85 years old: Oxycodone 4mg immediate release
\> 85 years old: Oxycodone 3mg immediate release
\<50kg or particularly frail: Oxycodone 2mg immediate release
Oxycodone
Intervention Type
DRUG
Oral solution
INTERVENTION GROUP WITH SUBCUTANEOUS ALFENTANIL
These patients will receive subcutaneous alfentanil prior to their post operative day 1 and 2 physiotherapy sessions
This is 100 micrograms as a subcutaneous injection
Alfentanil
Intervention Type
DRUG
Subcutaneous injection
Interventions
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Alfentanil
Subcutaneous injection
Intervention Type
DRUG
Oxycodone
Oral solution
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Listed for urgent hip fracture surgery - dynamic hip screw/cannulated hip screw/hemiarthroplasty/total hip arthroplasty/intramedullary nail
* Sustained an insufficiency/low energy type hip fracture
* Male or female aged over 60
* Able to provide informed consent
* Sustained an insufficiency/low energy type hip fracture
* Male or female aged over 60
* Able to provide informed consent
Exclusion Criteria
* Pathological or periprosthetic hip fracture
* Mechanism of injury for hip fracture was of high energy
* Patient is unable to comply with the study protocol or functional assessments
* Patients aged less than 60
* Patients who were wheelchair bound prior to injury
* Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Enrolment in existing research studies
* Mechanism of injury for hip fracture was of high energy
* Patient is unable to comply with the study protocol or functional assessments
* Patients aged less than 60
* Patients who were wheelchair bound prior to injury
* Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Enrolment in existing research studies
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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NHS Lothian
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Nicholas Clement, MBBS, MD, PhD, FRCS (T&O)
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
Locations
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Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom
Site Status
Countries
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United Kingdom
References
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Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, Genant HK, Palermo L, Scott J, Vogt TM. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet. 1993 Jan 9;341(8837):72-5. doi: 10.1016/0140-6736(93)92555-8.
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Brittain R, Howard P, Lawrence S, Stonadge J, Wilkinson M, Wilton T, et al. NJR statistical analysis, support and associated services National Joint Registry | 19th Annual Report. [cited 2023 Sep 1]; Available from: www.njrcentre.org.uk
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Health Scotland P. Scottish Hip Fracture Audit Report 2023 Reporting on episodes of hip fractures in 2022 A Management Information release for Scotland
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BACKGROUND
Scottish Hip Fracture Audit Report 2008 Contents. 2006 [cited 2023 Sep 1]; Available from: www.shfa.scot.nhs.uk
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Downey C, Kelly M, Quinlan JF. Changing trends in the mortality rate at 1-year post hip fracture - a systematic review. World J Orthop. 2019 Mar 18;10(3):166-175. doi: 10.5312/wjo.v10.i3.166. eCollection 2019 Mar 18.
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Gdalevich M, Cohen D, Yosef D, Tauber C. Morbidity and mortality after hip fracture: the impact of operative delay. Arch Orthop Trauma Surg. 2004 Jun;124(5):334-40. doi: 10.1007/s00402-004-0662-9. Epub 2004 Apr 17.
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Adeyemi A, Delhougne G. Incidence and Economic Burden of Intertrochanteric Fracture: A Medicare Claims Database Analysis. JB JS Open Access. 2019 Feb 27;4(1):e0045. doi: 10.2106/JBJS.OA.18.00045. eCollection 2019 Mar 27.
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Heiden JJ, Goodin SR, Mormino MA, Siebler JC, Putnam SM, Lyden ER, Tao MA. Early Ambulation After Hip Fracture Surgery Is Associated With Decreased 30-Day Mortality. J Am Acad Orthop Surg. 2021 Mar 1;29(5):e238-e242. doi: 10.5435/JAAOS-D-20-00554.
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Other Identifiers
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AC23143
Identifier Type: -
Identifier Source: org_study_id