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Femoral Nerve Blockage in Proximal Femoral Fractures in patients of 65 years of age or older, a Randomised Controlled Trial

Femoral Nerve Blockage in Proximal Femoral Fractures in patients of 65 years of age or older, a Randomised Controlled Trial - Femoral Nerve Blockage in Proximal Femoral Fractures

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45916
Enrollment
84
Registered
2016-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Hip fracture / Proximal femoral fracture

Interventions

The emergency physician will perform the ultrasound guided femoral nerve block with either Levobupivacaïne or plcebo sham injection. If the patient is transferred to the nursing room, the nurse of t

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Proven proximal femoral fracture (trochanteric, head and neck fractures) - Normal lower extremity anatomy and neurovascular examination - NRS pain score of *4 at admission - Aged 65 or older

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Cognitive impairment; previous diagnosed with dementia or MMSE * 22 - Delirium at inclusion - No good understanding of the Dutch language - Known hypersensitivity to local anaesthetics or morphine - Multi-trauma patients - Pre injury use of opioids - Pre injury bedridden or wheelchair bound patients

Design outcomes

Primary

MeasureTime frame
Raw pain intensity difference (PID) up to 4 hours after femoral nerve blockage. The raw PID was calculated as the change from baseline NRS for each measurement in time. The PID will be calculated from the first measured Numeric Rating Scale (NRS) (worst pain in the hour before the femoral nerve blockage). NRS for pain will be measured using a 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) at admission (before randomization), 1 hour, 2 hours and 4 hours after femoral nerve blockage. The percentage of patiënts with and without complications will be recorded. Next we will record every individual complication.

Secondary

MeasureTime frame
For the amount of opioid use, the electronic dossier of the patient will be reviewed. NRS for pain will be measured at 1, 2, 6 and every 6 hours after the nerve blockage until the operation. After surgery, NRS for pain will be monitored twice daily. Post-operative mobility score will be scored daily using the Cumulated Ambulation Score (CAS) for first three postoperative days.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)