The Natural History of the Pudendal Nerve Block

Natural history of Pudendal nerve block in female patients with chronic perineal pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000745943

Enrollment

150

Registered

2011-07-15

Start date

2008-10-01

Completion date

Unknown

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 firsrt aim of the study is to identify precisely how long a pudendal nerve block lasts and to find out how the different symptoms of pudendal neuralgia presented by the patient, evolve during the 52 hours following the pudendal nerve block. The second aim is to find out, for patients undergoing afterwards the pudendal nerve release surgery, if there is a correlation between the particular response to pudendal nerve block and the outcome after surgery. This will be a prospective study based on questionnaires. It will include a minimum of 50 women aged 18 or more, who had been referred to the Pudendal nerve Clinic in the Endogynaecology Department at the Royal Hospital for Women, who meet the entry criteria and who already consented to undergo a pudendal nerve block as part of their assessment. The participant will be asked to fill in a questionnaire, always the same, about her symptoms before, just after and then every 6 then 8 hours for 52 hours after the pudendal nerve block. If the patient undergoes a surgery to release the pudendal nerve entrapment, we will ask her to fill in that same questionnaire again 3, 6 and 12 months after the surgery.

Interventions

This injection is done by vaginal way, on both sides in the operating theatre under sedation. We inject 10ml of Ropivacaine, an amide-type local anesthetic, at a concentration 0.75% in each Alcock’s canal. We observed that after the block, the different symptoms return at different times after the block.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Sex: female. 2) Age range: 18+ years. 3) Diagnosis of Pudendal neuralgia according to the Aix-en-Provence Team criteria.

Exclusion criteria

1.Significant psycho-social disorders. 2.Inability to understand the questionnaire during the first appointment. 3.History of neurologic or neuromuscular disorder.

Outcome results