A randomised controlled trial of Eutectic Mixture of Lidocaine and Prilocaine (EMLA) cream as a primary dressing for painful chronic leg ulcers: A pilot study.

A randomised controlled trial of Eutectic Mixture of Lidocaine and Prilocaine (EMLA) cream as a primary dressing for the reduction in wound related pain associated with chronic leg ulcers: A pilot study.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001080213

Enrollment

Registered

2009-12-16

Start date

2010-09-16

Completion date

2013-03-20

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

The aims of this study will address the following hypotheses, that: The daily topical application of EMLA cream to the wound bed reduces pain levels for patients with a chronic leg ulcer. Improvement in pain levels will be associated with reduced need for oral analgesia, particularly opiates. Topical application of EMLA cream to the wound bed decreases healing time for chronic leg ulcers Improvement in leg ulcer pain and/or wound healing will be associated with gains in health-related quality of life. Hypothesis Our hypothesis is that the daily topical application of EMLA 5% cream to the wound bed of painful chronic leg ulcers as the primary dressing, will reduce wound-related pain and analgesic requirements, and improve the quality of life for patients with painful chronic leg ulcers. The secondary outcome measure is decreased wound healing times. As the primary outcome measure is pain reduction, this study will investigate painful chronic leg ulcers of varying aetiology, including venous, arterial and/or mixed ulceration.

Interventions

The participants will be randomized to receive EMLA 5% to their painful chronic lower leg ulcers daily as a primary dressing daily for a total of 4 weeks. The dose is 1gm per 10 sq cms. This topical cream will be applied to the wound bed by the participating community clinic nurses

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

Patient has one or more chronic lower leg ulcer(s) of at least 6 weeks duration and up to 100cm2 in size in total. Patients with low to moderate wound exudate. Numerical Rating Scale pain score = 4 at assessment and/or within the previous week. Patients currently requiring oral analgesics due to previously reported wound-related pain. Patients have the capacity to consent to participation. Patients have the capacity to attend the Community Nursing Procedure clinics.

Exclusion criteria

Patients scheduled for leg amputation. History of peripheral sensory neuropathy of the feet. Patients that have had or require the use of EMLA cream for debridement of the wound bed within the previous 4 weeks. Patients with suspected wound malignancy or pyoderma gangrenosum, confirmed by biopsy. Patients with diagnosed localized or spreading clinical wound infection. End stage palliative care patients. Allergy to EMLA cream and/or history of local anesthetic drug sensitivity A history of congenital or idiopathic methemoglobinemia Patients on Class III anti-arrhythmic drugs. Severe hepatic disease. Pregnant and/or lactating women.

Outcome results