None listed
Conditions
Brief summary
A double blind trial designed to assess the pain associated with the injection of lignocaine (Xylocaine) and mepivacaine (Scandonest) two local anaesthetics commonly used in podiatric practice. So, is mepiviacaine a less painful anaesthetic to be injected into a toe than lignocaine. Subjects will be selected from the University of Newcastle Podiatry Clinic, the subjects have been selected would require nail surgery of both big toes. The practitioner and the subject will be blinded to which anaesthetic has been used in each of the toes. After each injection the subject will be asked to complete a visual analog pain scale.
Interventions
A total of 2ml of 3% mepivacaine plain will be injected in the hallux (with 5ml syringe and a .25 gauge, 25mm in length) prior to the partial nail avulsion procedure. The subject will receive 1ml of mepivacaine into the soft tissue on the lateral (1st injection) and medial (2nd injection) aspects of the proximal phalanx. The partial nail avulsion will only be performed once the anaesthetic has taken effect. If anaesthesia has not been achieved then a top up injection will be performed.
The a
A total of 2ml of 3% mepivacaine plain will be injected in the hallux (with 5ml syringe and a .25 gauge, 25mm in length) prior to the partial nail avulsion procedure. The subject will receive 1ml of mepivacaine into the soft tissue on the lateral (1st injection) and medial (2nd injection) aspects of the proximal phalanx. The partial nail avulsion will only be performed once the anaesthetic has taken effect. If anaesthesia has not been achieved then a top up injection will be performed. The allocation of which hallux, right or left that receives lignocaine or mepivacaine will be randomised. Immediately after the injections into the medal and lateral aspects of the toe the subject will complete a visual analogue pain scale, if further injections are required then the visual analogue scale will be completed after the first (lateral aspect) and second injection (medial aspect). Crossover will be achieved by the randomly selected hallux will receive lignocaine or mepivacaine and the opposite hallux will be injected immediately after the subject has completed the visual analogue scale.
Sponsors
Mr Priten Solanki
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients eligible for and undergoing bilateral hallux partial nail avultion surgery (in accordance with the University of Newcastle Podiatry criteria) Minimum weight of 70kg Able to safely receive the local anaesthetic agents used (in accordance with the University of Newcastle Podiatry criteria) Over 18 yrs of age Proficient in English to give Informed Consent and follow post-operative care instructions
Exclusion criteria
Proficient in English to give Informed Consent and follow post-operative care instructions Patients not meeting the inclusion criteria Patients with medical conditions which contraindicate local anaesthetic use Patients on medications which contraindicate local anaesthetic use Patients with a known allergy to amide-type local anaesthetics
Outcome results
None listed