Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia? — REHAB  

Pain Clinical Trial

Official title: Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia (REHAB): a Prospective Cohort Study

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Early Ambulation
• Fractures, Bone
• Hip Fractures
• Hip Injuries
• Pain
• Pain, Postoperative
• Post Operative Pain

• NCT number: NCT06212622
• Study type: Observational
• Source: NHS Lothian
• Contact: Nicholas Clement, MBBS, MD, PhD, FRCS (T&O)
• Phone: 0131 2426462
• Email: Nick.Clement@nhslothian.scot.nhs.uk
• Status: Recruiting
• Start date: March 4, 2024
• Completion date: June 4, 2024