Nerve blockage in patients with a hip fracture.

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

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004119-19-NL

Enrollment

Unknown

Registered

2016-02-22

Start date

2016-04-25

Completion date

Unknown

Last updated

2016-05-09

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

Conditions

Pain in patients with a proximal femoral fracture.

Interventions

Trade Name: Chirocaine 5mg/ml Product Name: Chirocaine 5mg/ml Product Code: RVG 24618 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of ad

Eligibility

Sex/Gender

All

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84

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

Measure	Time frame
Main Objective: The objective of this study is to determine the clinical outcomes of ultrasound guided femoral nerve blockage using intermitting shots of levobupivacaine, in patients with hip fractures and to compare these results with placebo injections. The primary objective is to investigate if femoral nerve blockage leads to a decrease in pain and a decrease in complications (delirium, nausea, vomiting, obstipation, hypotension, urinary retention, and respiratory depression). This will be measured with the raw pain intensity difference up to 4 hours after the femoral block. The percentage of patiënts with and without complications will be recorded. Next we will record every individual complication. ;Secondary Objective: The secondary objectives of this study include the pain measured with NRS on multiple moments before and after surgery, the amount of analgesics used (paracetamol, non-steroid anti-inflammatory drugs and opioids), length of hospital stay, post-operative mobility status and subsequent discharge location. ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: After a patient is included a baseline painscore will be measured (heaviest pain in previous hour). Painscore questionnaires will be repeated at 4 hours and will be recorded as the raw pain intensity difference. If the patient is transferred to the nursi	—

Measure

Time frame

Main Objective: The objective of this study is to determine the clinical outcomes of ultrasound guided femoral nerve blockage using intermitting shots of levobupivacaine, in patients with hip fractures and to compare these results with placebo injections. The primary objective is to investigate if femoral nerve blockage leads to a decrease in pain and a decrease in complications (delirium, nausea, vomiting, obstipation, hypotension, urinary retention, and respiratory depression). This will be measured with the raw pain intensity difference up to 4 hours after the femoral block. The percentage of patiënts with and without complications will be recorded. Next we will record every individual complication. ;Secondary Objective: The secondary objectives of this study include the pain measured with NRS on multiple moments before and after surgery, the amount of analgesics used (paracetamol, non-steroid anti-inflammatory drugs and opioids), length of hospital stay, post-operative mobility status and subsequent discharge location. ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: After a patient is included a baseline painscore will be measured (heaviest pain in previous hour). Painscore questionnaires will be repeated at 4 hours and will be recorded as the raw pain intensity difference. If the patient is transferred to the nursi

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Secondary

Measure	Time frame
Secondary end point(s): The amount of opioid use. Pre and postoperative NRS for pain Post-operative mobility ;Timepoint(s) of evaluation of this end point: Painscore questionnaires will be repeated at 1 hour, 2 hours, 6 hours and every consecutive 6 hours until surgery. For the use of rescue analgesics the electronic dossier of the patient will be reviewed. If the patient is transferred to the nursing room, the nurse of the department will daily measure NRS for pain After surgery, the NRS for pain is measured twice by the researcher. Furthermore, the cumulated ambulation score (CAS) is monitored daily during the first three postoperative days by the researcher who is blinded.	—

Measure

Time frame

Secondary end point(s): The amount of opioid use. Pre and postoperative NRS for pain Post-operative mobility ;Timepoint(s) of evaluation of this end point: Painscore questionnaires will be repeated at 1 hour, 2 hours, 6 hours and every consecutive 6 hours until surgery. For the use of rescue analgesics the electronic dossier of the patient will be reviewed. If the patient is transferred to the nursing room, the nurse of the department will daily measure NRS for pain After surgery, the NRS for pain is measured twice by the researcher. Furthermore, the cumulated ambulation score (CAS) is monitored daily during the first three postoperative days by the researcher who is blinded.

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Countries

Netherlands

Contacts

Public ContactNina Mathijssen

Reinier de Graaf Hospital

n.mathijssen@rdgg.nl00310152603718

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026