Better ways of pain management in adults with hip fractures

Neck Of Femur fracture pain management with ultrasound-guided single bolus versus repeated bolus Fascia Iliaca CatheterS in the Emergency Department: a double-blind, randomized controlled trial. (NOF-FICSED)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001884291

Acronym

NOF-FICSED

Enrollment

122

Registered

2018-11-20

Start date

2019-07-01

Completion date

2020-07-01

Last updated

2019-07-15

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

Conditions

None listed

Brief summary

The purpose of this study is to compare ultrasound guided repeat fascia iliaca blocks delivered through a catheter to ultrasound guided single blocks delivered through a catheter with a saline control in emergency department hip fracture patients. The outcomes measured will be behavioural pain scores, verbal pain scores, opioid use, and incidence of delirium. Further a health economic component will analyse cost effectiveness of both interventions. We predict based on the literature and a pilot study that repeated boluses will be less painful, use less opioids, and have decreased incidences of delirium.

Interventions

Single vs repeated bolus fascia iliaca (FICB) nerve blocks from emergency department to surgery. Arm 1: 40ml 0.2% Ropivacaine through a FICB catheter followed by 2hrly 20ml 0.2% Ropivacaine through the same FICB catheter until surgery. This duration maybe anywhere from 6 - 48 hours. Arm 2: 40ml 0.2% Ropivacaine through a FICB catheter followed by 2hrly 20ml 0.9% saline through the same FICB catheter until surgery. This duration maybe anywhere from 6 - 48 hours.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults over the age of 50 years with a radiologically-proven neck of femur fracture and ability to consent

Exclusion criteria

Interhospital transfers, Refusal of consent, Individuals with weights less than 50kg, Local site infection, Allergies to local anaesthetics, Liver failure, Dangerous or combative patients, Altered anatomy (such as past femoral bypass), Unwell patients requiring immediate resuscitation

Outcome results