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

March 20, 2024 updated by: NHS Lothian

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Drug: Alfentanil
Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale score
Time Frame: On post operative day 1
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
Time Frame: On post operative day 1

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale score
Time Frame: On post operative day 2
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 2
Ability to mobilise
Time Frame: On post operative day 2

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 2
EuroQol five dimension (EQ-5D) - 5L patient reported outcome measure
Time Frame: At post operative day (POD) 1, POD2, POD 7 and POD 30
The EQ-5D-5L consists of questions in domains of mobility, self-care, usual activities of daily living, pain/discomfort and anxiety/depression. There are five options for marking severity for each domain. There is also a VAS, rating how the patient perceives health related quality of life from 0-100.
At post operative day (POD) 1, POD2, POD 7 and POD 30
In hospital length of stay
Time Frame: From date of admission until the date of discharge from hospital or date of death, whichever came first (assessed up to 52 weeks)
In hospital length of stay will be calculated as the number of days in hospital, from the date of admission to the day of discharge.
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
Time Frame: post operative day 1 and post operative day 2
This outcome will be assessed to determine if early mobilisation helps reduce overall postoperative pain during in hospital admission, and see if differing analgesic modalities has any effect on this.
post operative day 1 and post operative day 2
Complication rates and 30-day mortality
Time Frame: At post operative day (POD) 1, POD2, POD 7 and POD 30

Each patient will be followed up, via their internal TRAKcare patient notes to determine 30-day mortality. Complication rates will be assessed at POD 1, POD 2 and POD 7 alongside the EQ-5D-5L questionnaire. They will also then be followed up at 30 days to assess any further complications. The following complications will be assessed:

  • Any complication
  • Post operative delirium
  • Surgical site infection
  • Wound dehiscence
  • Pneumonia
  • Pulmonary embolism
  • Acute kidney injury
  • Urinary tract infection
  • Cerebrovascular accident
  • Cardiac arrest
  • Myocardial infarction
  • Deep vein thrombosis
  • Delirium
  • Sepsis
  • Mortality
  • Dislocation
  • Re-operation (and reason for this)
  • Readmission (and reason(s) for this)
At post operative day (POD) 1, POD2, POD 7 and POD 30
Discharge destination
Time Frame: Pre admission location will be assessed on the date of admission. Discharge destination will be sought, on the date of discharge from hospital (assessed up to 52 weeks)
The discharge destination will be sought, and compared with pre-admission status (e.g. at home/care home/residual home), to determine if analgesic modality affects discharge destination
Pre admission location will be assessed on the date of admission. Discharge destination will be sought, on the date of discharge from hospital (assessed up to 52 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Lothian

Investigators

  • Principal Investigator: Nicholas Clement, MBBS, MD, PhD, FRCS (T&O), NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

May 4, 2024

Study Completion (Estimated)

June 4, 2024

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC23143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Oxycodone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe