Clinical trial

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

Name
AC23143
Description
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.
Trial arms
Trial start
2024-03-04
Estimated PCD
2024-05-04
Trial end
2024-06-04
Status
Recruiting
Treatment
Alfentanil
Subcutaneous injection
Arms:
INTERVENTION GROUP WITH SUBCUTANEOUS ALFENTANIL
Oxycodone
Oral solution
Arms:
STANDARD CARE WITH ORAL OXYCODONE
Size
64
Primary endpoint
Visual analogue scale score
On post operative day 1
Ability to mobilise
On post operative day 1
Eligibility criteria
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 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}
Updated at
2024-03-21

1 organization

2 products

5 indications

Organization
NHS Lothian
Product
Alfentanil
Indication
Hip Injuries
Indication
Hip Fractures
Indication
Pain
Indication
Ambulation
Product
Oxycodone