Efficacy of repeated pudendal nerve block combined with physiotherapy for the prevention of chronic Post-Episiotomy pain and dyspareunia: a randomized controlled trial
NCT ID NCT07814183
First seen Sep 10, 2026 · Last updated Sep 10, 2026
Summary
This prospective, single-center, open-label, randomized controlled trial will evaluate whether repeated ultrasound-guided pudendal nerve block combined with standardized physiotherapy and standard postpartum analgesic management reduces persistent post-episiotomy pain and postpartum dyspareunia compared with standard management alone. Women aged 18-40 years who have undergone vaginal delivery with episiotomy or a first-time perineal tear and who report postpartum pain greater than 3/10 within 24 hours after delivery will be randomized in a 1:1 ratio. The intervention group will receive standard management plus a repeated pudendal nerve block before hospital discharge and a second block on postpartum Day 10 if pain remains greater than 3/10. Pain and sexual function will be assessed through 3 months postpartum.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must meet all of the following: * Women aged 18-40 years. * Term pregnancy. * Vaginal delivery with episiotomy or first-time perineal tear. * Postpartum pain score \>3/10 within 24 hours after delivery. * Willingness to participate and provide informed consent. - Exclusion Criteria: * Refusal to participate. * Previous episiotomy or perineal tear. * Pain score ≤3/10. * Known allergy to study medications. * Pre-existing pudendal neuralgia. * Pre-existing dyspareunia.
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