EFFICACY OF ROUTINE MANAGEMENT BY LOCAL ANAESTHETIC INFILTRATION IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL AGAINST SALINE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001494-23-FR

Enrollment

Registered

2021-04-29

Start date

2021-06-10

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Patients with pudendal neuralgia who have failed drug treatment

Interventions

Trade Name: LIDOCAINE AGUETTANT 10 mg/ml SANS CONSERVATEUR, solution injectable Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient 18 years of age or older, - Express consent to participate in the study - Affiliated or beneficiary of a social security plan - With pudendal neuralgia (modified Nantes criteria). - MRI normal or without pathology explaining the pain - Failure of drug treatment as defined in the NPs, i.e. failure (VAS decrease =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Patient benefiting from a legal protection measure - Pregnant or breastfeeding woman - General and/or local infection (fistulous or cutaneous suppuration of the anal margin) in progress - Known neurological pathology that may explain the pain - Psychiatric pathology requiring medical treatment - Anticoagulants or haemostasis disorders - Hypersensitivity to lidocaine hydrochloride, local anaesthetics - Recurrent porphyrias

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effectiveness of NPTIs performed under neurostimulation on pain at 1 month after a local anaesthetic infiltration in the treatment of NP;Secondary Objective: Compare between the two treatment arms: 1) The rate of maintenance at 3 months of a positive response to the first infiltration. 2) The rate of patients without pain at 1 month after the first infiltration. 3) The evolution of quality of life and pain impact between inclusion and one month after the first infiltration. 4) The evolution of anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration. 5) The evolution of symptoms related to central sensitisation (both somatic and emotional) between inclusion and one month after the first infiltration. ;Primary end point(s): Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a decrease of at least 3 points on a visual analogue pain scale (VAS) between inclusion and 1 month after the first injection;Timepoint(s) of evaluation of this end point: 1 month	—

Measure

Time frame

Main Objective: Evaluate the effectiveness of NPTIs performed under neurostimulation on pain at 1 month after a local anaesthetic infiltration in the treatment of NP;Secondary Objective: Compare between the two treatment arms: 1) The rate of maintenance at 3 months of a positive response to the first infiltration. 2) The rate of patients without pain at 1 month after the first infiltration. 3) The evolution of quality of life and pain impact between inclusion and one month after the first infiltration. 4) The evolution of anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration. 5) The evolution of symptoms related to central sensitisation (both somatic and emotional) between inclusion and one month after the first infiltration. ;Primary end point(s): Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a decrease of at least 3 points on a visual analogue pain scale (VAS) between inclusion and 1 month after the first injection;Timepoint(s) of evaluation of this end point: 1 month

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Secondary

Measure	Time frame
Secondary end point(s): 1) Maintenance of positive response at 3 months defined by a continued decrease of at least 3 points on the VAS (compared to inclusion) 3 months after infiltration. 2) Percentage of patients with a VAS score of 0 at 1 month after the first infiltration. 3) Delta of the score on question 9 of the "modified" Brief Pain Questionnaire (French version of the Brief Pain Inventory) concerning the impact of pain (Appendix 2). 4) Delta of the scores A (anxiety dimension) and D (depression dimension) on the HAD scale (Appendix 3). 5) Delta of the score for part A of the French version of the CSI central awareness score (Appendix 4).;Timepoint(s) of evaluation of this end point: 1 and 3 months	—

Measure

Time frame

Secondary end point(s): 1) Maintenance of positive response at 3 months defined by a continued decrease of at least 3 points on the VAS (compared to inclusion) 3 months after infiltration. 2) Percentage of patients with a VAS score of 0 at 1 month after the first infiltration. 3) Delta of the score on question 9 of the "modified" Brief Pain Questionnaire (French version of the Brief Pain Inventory) concerning the impact of pain (Appendix 2). 4) Delta of the scores A (anxiety dimension) and D (depression dimension) on the HAD scale (Appendix 3). 5) Delta of the score for part A of the French version of the CSI central awareness score (Appendix 4).;Timepoint(s) of evaluation of this end point: 1 and 3 months

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Countries

France

Contacts

Public ContactClinical research director

Hôpital Fondation A. de Rothschild

33148036454

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026