Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04478552 |
| Other study ID # |
SPv1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
October 14, 2021 |
Study information
| Verified date |
May 2023 |
| Source |
United Christian Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
As population in Hong Kong is aging, incidence of geriatrics hip fractures rises. Operative
treatment for selective patients offers pain control, early mobilization and reduction in
medical morbidities and mortalities. Research has shown that the pain from hip fracture left
untreated may have significant physical and psychological effects on the patient,
precipitating delirium, especially in elderly patients with hip fractures, and may delay
operative management and may complicate hospital stay. Studies report that the pain
management for limb fractures in the elderly is hugely sub-optimal with some suggesting that
only 2% receive adequate analgesia. Adequate analgesia before definitive treatment of hip
fracture may improve mobilization and cognitive performance. As a part of multi-modal pain
management, Fascia iliaca compartment block is being increasingly popular as a simple, safe
and effective regional technique for patients with hip fractures and proximal femoral shaft
fractures, providing consistent analgesic effect for hip fracture patients, irrespective of
the performing doctor's experience. This study aims to provide high level local evidence of
the effect and efficacy of the fascia iliaca compartment block in preoperative pain control
for patients with hip fracture admitted to Orthopaedic and Traumatology ward in United
Christian Hospital.
Description:
This study is a randomized control, single blinded trial. It tests the hypothesis that fascia
iliaca compartment block using local anaesthetic agent for pre-operative analgesia in
patients with hip fracture, compared to that using normal saline as control, leads to a
better pain control and fewer doses of systemic analgesics required. All patients admitted to
United Christian Hospital Orthopaedic and Traumatology ward for hip fracture with
radiological diagnosis will be seen by on-call resident. Principal investigator and other
investigators will be notified of the admission within 1 working day. Subjects will be
recruited according to inclusion and exclusion criteria as mentioned in the below section.
Subjects will be recruited only if an informed consent for this study has been signed. Only
patients with hip fracture pending emergency operation will be recruited. 2 enclosed
envelopes will be prepared, in which one indicates "intervention", and one indicates
"control". Subjects will randomly choose any of the envelopes without knowing the
intervention/control group assignment. To maintain true randomization, the 2 envelopes will
be kept in good condition, preventing identification of the underlying assignment from the
outer appearance. Investigators, knowing the group assignment, will then prepare an injection
kit set for Fascia iliaca compartment block which includes vials of levobupivacaine, normal
saline, syringes, 22G/21G needle, simple dressing set and skin antiseptic solution. For the
intervention group, fascia iliaca compartment block with 30ml/40ml 0.25% levobupivacaine,
depending on body weight (30ml for body weight less than 50kg, 40ml for body weight more than
50kg), will be performed by investigators under landmark approach. For the control group,
same volume of normal saline, instead of levobupivacaine, will injected using the same
technique, so that single blinding can be achieved. Subjects' vital signs will be observed
for every 10 minutes for 30 minutes after injection.
