None listed
Conditions
Brief summary
This study is a randomised cross-over trial assessing the efficacy of the addition of hyaluronic acid (HA) to levobupivicane in pudendal nerve blockade as a treatment for pudendal neuralgia. Previous studies have demonstrated that application of local anaesthetic along the path of the pudendal nerve results in the onset of numbness and a reduction in symptoms. This result is however, most often limited from a few hours to a few days . Recent studies have suggested that the addition of hyaluronic acid to the local anaesthetic blockade can result in improved and prolonged analgesia. AIM; to determine whether the addition of hyaluronic acid to local anaesthetic results in improved post-blockade pain scores, change in medication use and change in pain interference in daily activities. MATERIALS AND METHODS; This is a triple-blind randomised cross-over study in which each participant will receive two pudendal nerve blocks 3 months apart one of which will contain hyaluronic acid + levobupivicaine and the other placebo + levobupivicaine. Assessment of symptoms and effect on function will be via use of The Brief pain inventory – short form. We will also assess analgesia use pre and post blockade. RESULTS; Differences in pain and function scores pre and post blockade will be assessed using the students t-test with adjustments made for multiple comparisons. We will also use descriptive statistics to review any changes in medication use. CONCLUSION; if our null hypothesis is true we would expect to see no difference between HA acid and placebo. However, if the HA is effective then we would hope to see improved pain scores, decreased pain interference with life and potentially decreased medication use.
Interventions
This is a randomised cross-over trial looking at the efficacy of adding hyaluronic acid to local anaesthetic when performing pudendal nerve blocks for the treatment of pudendal neuralgia.
Medication;
- levobupivicaine 0.5% 3ml
- 3ml hyaluronic acid 1% OR 3ml placebo gel
- deep tissue neural block performed via a transgluteal approach under x-ray guidance
- two treatments
- treatments consist of either a unilateral or bilateral block (depending on patient symptoms) and are performed on two occas
This is a randomised cross-over trial looking at the efficacy of adding hyaluronic acid to local anaesthetic when performing pudendal nerve blocks for the treatment of pudendal neuralgia. Medication; - levobupivicaine 0.5% 3ml - 3ml hyaluronic acid 1% OR 3ml placebo gel - deep tissue neural block performed via a transgluteal approach under x-ray guidance - two treatments - treatments consist of either a unilateral or bilateral block (depending on patient symptoms) and are performed on two occasions with a 3 month wash out period between
Sponsors
WHRIA
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of pudendal neuralgia No previous pudendal nerve block
Exclusion criteria
Previous pudendal nerve block
Outcome results
None listed