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RAPID: Fast pain relief for hip fracture: a study with paramedics.

Rapid Analgesia for Prehospital Hip Disruption (RAPID): a feasibility study for a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60065373
Enrollment
50
Registered
2015-11-11
Start date
2016-05-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hip fracture, in the prehospital environment Musculoskeletal Diseases Patients with hip fracture, in the prehospital environment

Interventions

Participants are randomly allocated to one of two groups. 1. Group 1: Patients receive standard treatment and given normal pain relief (usually morphine) 2. Group 2: P

Sponsors

Welsh Ambulance Services NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Patients who are assessed by a paramedic as having a hip fracture (paramedics will make this assessment by using a hip fracture diagnosis checklist tool)

Exclusion criteria

Exclusion criteria: 1. Patient refuses to participate 2. Patient is combative 3. Patient has an allergy to local anaesthetic 4. Patient is receiving coagulopathy (use of warfarin, clopidogrel or ‘new’ anticoagulants) 5. Patient has any other distracting injury (i.e. has pain in a different place, which would make taking pain scores for only the hip difficult) 6. Patient has decreased level of consciousness (Glasgow Coma Scale score of less than 14) 7. Patient is haemodynamically unstable 8. Patient has neurovascular damage to the affected leg 9. Patient has received previous femoral bypass surgery 10. Patient has an infection at the site of insertion of the injection 11. The paramedic is unable to palpate the femoral artery on the affected leg 12. Patients who appear to have body mass of less than 50kg (A 50kg patient could safely be given 6ml/kg of 1% prilocaine. By only using 30ml of the local anaesthetic, we will have a margin of safety to avoid patients developing local anaesthetic toxicity).

Design outcomes

Primary

MeasureTime frame
Our feasibility study objectives are as follows: to assess 1. Accuracy, in particular specificity, of recognition of hip fracture by paramedics in order to establish appropriate and safe delivery of the intervention. 2. Willingness of both patients and paramedics to participate in the study. 3. Compliance with the intervention by paramedics. 4. Sample size required for a full RCT, and recruitment period required to achieve target. 5. Acceptability of the method of providing pain relief in the prehospital care of patients with hip fracture. 6. Which outcome measures should be used in a full RCT and at what point they should be recorded. Proposed outcomes measures to be tested are: 6.1. Self-reported pain level using numeric rating scale of 0- 10 with 0 being no pain at all and 10 being the worst pain imaginable. This will be recorded immediately before pain relief is given and repeated on arrival at the hospital by the triage nurse (before they know which pain relief the patient received). 6.2. Patient satisfaction with the care they received from paramedics using a modified Quality of Care Monitor. This will be measured when the NHS researcher takes consent to participate in the trial at approximately 7-10 days after the patient's injury 6.3. Complications of FICB (Patient safety – adverse events (AE) and serious adverse events (SAE) will be recorded) 6.4. Length of time that the paramedics were with the patient (in order to determine whether providing FICB has a significant effect of delaying the paramedics) 6.5. Requirement of antiemetics and alternative analgesia 6.6. Length of stay 6.7. Mortality at 30 days and/or at six months 6.8. Time from admission to surgery 6.9. Health related quality of life, using SF12 at 30 days and/o

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom, Wales

Contacts

Public ContactJenna Bulger

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026