In patients undergoing ultrasound-guided fascia iliaca compartment blockade before knee replacement surgery, does the addition of hyaluronidase to the local anaesthetic solution improve the success rate and hasten the onset of the nerve blockade?

Does the addition of hyaluronidase to ultrasound-guided fascia iliaca compartment block improve the time to onset and extent of anaesthesia in patients undergoing unlilateral knee arthroplasty?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000401853

Enrollment

100

Registered

2012-04-10

Start date

2010-10-04

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

We aim to investigate the effect of the drug hyaluronidase on the efficacy of ultrasound-guided fascia iliaca compartment block (FICB). Hyauluronidase is a naturally occurring enzyme that it available as a drug. It possesses spreading properties and it is used as a pharmaceutical agent to facilitate the dispersion of drugs and other substances. It has been proven to be effective in enhancing ocular regional anaesthesia but it has not been adequately studied in peripheral regional blockade. FICB is a safe and effective method of lumbar plexus regional anaesthesia. The goal of FICB is to provide femoral nerve, lateral cutaneous nerve of the thigh and obturator nerve block. While the femoral nerve and lateral cutaneous nerve of the thigh are reliably blocked by FICB the overall success rate of the block is limited by obturator nerve anaesthesia which is successful in only ~44% of ultrasound guided FICB - presumably due to the distance the local anaesthetic must traverse from its site of infiltration to reach this nerve. We hypothesise that adding hyaluronidase to a plain 0.5% ropivacine local anaesthetic solution will increase the success of FICB - chiefly the proportion of patients achieving obturator nerve anaesthesia (weakness of thigh adduction). We will also study effects on the speed of onset and blood levels of co-administered local anaesthetic. An improvement in the success of FICB should improve post-operative pain after knee replacement. If proven, there may also be other peripheral nerve block procedures that may benefit from the addition of hyaluronidase.

Interventions

30mL 0.5% ropivacaine with/without hyaluronidase powder 1500IU (i.e. 50IU/mL hyaluronidase) will be used for fascia iliaca compartment block. A single block fascia iliaca compartment procedure is performed approximately 30minutes before commencement of surgery. The solution is delivered to the fascia iliaca compartment (deep to the fascia iliaca and superficial to the iliacus muscle in the groin). The needle tip is directed into the correct position with ultrasound guidance.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Patients undergoing single-sided, first-time total knee replacement Male or female; 18-80 years of age at the time of surgery Must be able to understand the possible anaesthetic complications and study protocol

Exclusion criteria

Any refusal/contraindication to fascia iliaca compartment block Allergy to study medications Pregnancy Inability to communicate with authors Morbid obesity [Body Mass Index (BMI) > 35kg/m2] Known hepatic or renal insufficiency Pre-existing neurological deficit of lower limbs

Outcome results