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

Withdrawn

• Conditions: Hip fracture / Proximal femoral fracture; 10005942; 10005944

• Registration Number: NL-OMON45916
• Lead Sponsor: Reinier de Graaf Groep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 84

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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