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The effect of dexamethasone on duration of analgesia from fascia iliaca compartment blocks in emergency department patients with hip fractures

Effect of intracompartmental dexamethasone on the duration of infra-inguinal ultrasound guided fascia iliaca compartment block performed in the emergency department on adult patients with hip fractures: a double blind randomised controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000789864
Enrollment
1
Registered
2021-06-23
Start date
2021-10-28
Completion date
2022-07-02
Last updated
2021-12-27

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

Conditions

None listed

Brief summary

Hip fractures are a common occurrence in the community and cause severe acute pain. Traditional methods of analgesia rely heavily on systemic opioid administration, which has several predictable and undesirable side-effects. Consequently, there has been a recent emphasis on peripheral nerve blockade as an opioid sparing analgesic in patients with hip fractures. The blockade is usually performed with long-acting local anaesthetics and works by decreasing pain transmission from the site of injury to the central nervous system. There has been recent research into the role of adjuvants, such as dexamethasone, added to the nerve blockade injectate. These adjuvants are purported to improve duration of analgesia, but these findings have not yet been replicated in emergency department patients with hip fractures. This study aims to assess the duration of analgesia gained from plain ropivacaine ultrasound guided fascia iliaca compartment block (USG-FICB) as compared to ropivacaine USG-FICB augmented by intracompartmental dexamethasone. This is a single-centre, prospective, double blinded randomised control study design which aims to assess the duration of analgesia gained from plain ropivacaine USG-FICB as compared to ropivacaine USG-FICB augmented by intracompartmental dexamethasone. Enrolled patients will be randomised to receive an USG-FICB with either ropivacaine + dexamethasone OR ropivacaine + placebo (i.e. ropivacaine alone). Duration of analgesia will be assessed based on timing of breakthrough opioid following the USG-FICB.

Interventions

This study aims to assess the duration of analgesia gained from plain ropivacaine ultrasound guided fascia iliaca compartment block (USG-FICB) as compared to ropivacaine USG-FICB augmented by intracompartmental dexamethasone. Enrolled patients will be randomised to receive an USG-FICB with either ropivacaine + dexamethasone OR ropivacaine + placebo. Duration of analgesia will be assessed based on timing of breakthrough opioid following the USG-FICB. An external third party will prepare syring

This study aims to assess the duration of analgesia gained from plain ropivacaine ultrasound guided fascia iliaca compartment block (USG-FICB) as compared to ropivacaine USG-FICB augmented by intracompartmental dexamethasone. Enrolled patients will be randomised to receive an USG-FICB with either ropivacaine + dexamethasone OR ropivacaine + placebo. Duration of analgesia will be assessed based on timing of breakthrough opioid following the USG-FICB. An external third party will prepare syringes containing 1 mL of either normal saline or 1 mL of dexamethasaone 4mg/mL. They will be labelled such that blinding can be maintained. e.g. "A" or "B", in identical syringes. 150 mg of ropivacaine will be diluted into 39 mL of 0.9% saline. If randomised to intervention, 1 mL of 4mg/mL dexamethasone (blinded) will be added to this syringe. This will result in a 0.375% ropivacaine and 0.1 mg/mL dexamethasone solution. If a patient weighs less than 60 kg, 30 mL of this solution will be injected into the compartment. If the patient weighs 60-70 kg, 35 mL of this solution will be injected into the compartment. If the patient weighs more than 70 kg, 40 mL of this solution will be injected into the compartment. This intervention will only occur once, close to the time of presentation and randomisation. As noted above, the dexamethasone and ropivacaine will be administered at the same time, in the same syringe. The person performing the intervention will be an emergency department doctor trained in the procedure and study protocol. Administration will be recorded in the electronic medical record, including the random allocation to "A" or "B".

Sponsors

Bashir Chakar
Lead SponsorIndividual

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
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male and female patients with a radiographically confirmed hip fracture 2. Age greater than or equal to 18 years 3. Emergency department triage between 07:30 and 23:59 4. Willing and able to provide informed consent.

Exclusion criteria

1. Critically unwell patients 2. Fractures at multiple anatomical sites 3. Delirium 4. Severe cognitive impairment 5. Infection at the injection site 6. Previous femoral bypass surgery 7. Allergy to local anaesthetics 8. Chronic pain condition 9. Known polyneuropathy 10. History of opioid abuse 11. Pregnant or breastfeeding 12. No trained clinician available to perform the USG-FICB.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026