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

NCT06212622 | Completed FDA Drug

• 1 other identifier: AC23143
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Injuries; Hip Fractures; Pain; Post Operative Pain; Early Ambulation

Keywords

early mobilisation; hip fracture; pain; oxycodone; alfentanil; ambulation

Outcome Measures

Primary Outcomes (2)

• Visual analogue scale score

  Pain assessment using the visual analogue scale. This is a visual scale measured from 0 to 10, where 0 is no pain and 10 is very severe pain.

  On post operative day 1

• Ability to mobilise

  Ability to mobilise based on pre assigned physiotherapy levels (PT): * PT level 1 -\> standing transfer: ability to weight bear on both legs, and transferring from bed to chair without stepping. Equipment will be utilised to help the patient swing round from bed to chair (sara steady/sam hall turner) * PT level 2 -\> stepping transfer: ability to weight bear on both legs, and transferring from bed to chair with stepping. Equipment will be utilised to help support the patient when stepping (gutter frame/Zimmer frame) * PT level 3A -\> mobilising to the toilet with assistance of two people * PT level 3B -\> mobilising to the toilet with assistance of one person * PT level 3C -\> mobilising to the toilet without assistance

  On post operative day 1

Secondary Outcomes (7)

• Visual analogue scale score

  On post operative day 2

• Ability to mobilise

  On post operative day 2

• EuroQol five dimension (EQ-5D) - 5L patient reported outcome measure

  At post operative day (POD) 1, POD2, POD 7 and POD 30

• In hospital length of stay

  From date of admission until the date of discharge from hospital or date of death, whichever came first (assessed up to 52 weeks)

• Total use of analgesia over post operative day 1 and post operative day 2

  post operative day 1 and post operative day 2

Study Arms (2)

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

Drug: Oxycodone

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

Drug: Alfentanil

Interventions

Alfentanil DRUG

Subcutaneous injection

INTERVENTION GROUP WITH SUBCUTANEOUS ALFENTANIL

Oxycodone DRUG

Oral solution

STANDARD CARE WITH ORAL OXYCODONE

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants listed for urgent hip fracture surgery, after sustaining a hip fracture surgery under the care of participating surgeons at the institution of RIE. 64 participants will be included in this prospective cohort study, 32 in each cohort. There will be consecutively recruitment and follow all hip fracture patients admitted over a month at RIE.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

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MeSH Terms

Conditions

Hip Injuries; Hip Fractures; Pain; Pain, Postoperative

Interventions

Alfentanil; Oxycodone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Femoral Fractures; Fractures, Bone; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Nicholas Clement, MBBS, MD, PhD, FRCS (T&O)

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 19, 2024
• Study Start: March 4, 2024
• Primary Completion: June 18, 2024
• Study Completion: July 18, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)