Abstract
OBJECTIVE: To compare the effect of corticosteroids combined with local anaesthetic versus local anaesthetic alone during infiltrations of the pudendal nerve for pudendal nerve entrapment. DESIGN: Randomised, double-blind, controlled trial. SETTING: Multicentre study. POPULATION: 201 patients were included in the study, with a subgroup of 122 women. METHODS: CT-guided pudendal nerve infiltrations were performed in the sacrospinous ligament and Alcock's canal. There were three study arms: patients in Arm A (n = 68) had local anaesthetic alone, those in Arm B (n = 66) had local anaesthetic plus corticosteroid and those in Arm C (n = 67) local anaesthetic plus corticosteroid with a large volume of normal saline. MAIN OUTCOME MEASURES: The primary end-point was the pain intensity score at 3 months. Patients were regarded as responders (at least a 30-point improvement on a 100-point visual analogue scale of mean maximum pain over a 2-week period) or nonresponders. RESULTS: Three months' postinfiltration, 11.8% of patients in the local anaesthetic only arm (Arm A) were responders versus 14.3% in the local anaesthetic plus corticosteroid arms (Arms B and C). This difference was not statistically significant (P = 0.62). No statistically significant difference was observed in the female subgroup between Arm A and Arms B and C (P = 0.09). No significant difference was detected for the various pain assessment procedures, functional criteria or quality-of-life criteria. CONCLUSIONS: Corticosteroids provide no additional therapeutic benefits compared with local anaesthetic and should therefore no longer be used. TWEETABLE ABSTRACT: Steroid infiltrations do not improve the results of local anaesthetic infiltrations in pudendal neuralgia.