Repeated Pudendal Nerve Block and Physiotherapy for Prevention of Chronic Post-Episiotomy Pain

NCT07814183 | Not Yet Recruiting DMC

• 1 other identifier: REPP
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Post-episiotomy Pain; Postpartum Dyspareunia

Keywords

Episiotomy; analgesic pudendal nerve block; Chronic post episiotomy pain; post partum dyspareunia

Outcome Measures

Primary Outcomes (1)

• Composite outcome of persistent pain and dyspareunia Incidency

  The primary outcome is a binary composite outcome assessed at Week 8 postpartum. An unfavorable outcome will be defined as the presence of moderate or greater pain according to the VAS measure at the consultation of week 8 and dyspareunia according to the pain domain of the Female Sexual Function Index (FSFI). This binary composite outcomes will be the incidence of patients with VAS \> 3 or FSFI pain-domain score \<26,55 indicating dyspareunia - no/Total no. (%)

  Post partum at end of week 8

Secondary Outcomes (6)

• pain intensity

  Postpartum at Day 1, day 10, end of week 8 and end of month 3.

• Dyspareunia

  post partum end of week 8 and end of month 3 after delivery

• pudendal nerve block failure

  30 minutes after pudendal block performance

• adverses events as Local anesthetic systemic toxicity, Hematoma, Infection or Rectal perforation

  Post partum from day of delivery though discharge up to 1 week

• Quality of recovery

  Post partum 24 hours after delivery and at day 10 after delivery

Study Arms (2)

Standard Management

NO INTERVENTION

Participants will receive standard postpartum analgesic management consisting of: Paracetamol 500 mg orally every 6 hours Celecoxib 200 mg orally every 12 hours Nefopam as needed for pain \>3/10 Standardized physiotherapy including breathing exercises, pelvic floor exercises and perineal massage

Repeated Pudendal Nerve Block + Standard Management

EXPERIMENTAL

Participants will receive standard management plus ultrasound-guided pudendal nerve block before hospital discharge if perineal pain \>3.

Procedure: Ultrasound-Guided Pudendal Nerve Block

Interventions

Ultrasound-Guided Pudendal Nerve Block PROCEDURE

A transperineal ultrasound-guided pudendal nerve block will be performed using a high-frequency linear ultrasound probe on the side of the episiotomy. The pudendal neurovascular bundle will be identified and the needle advanced under ultrasound guidance. After negative aspiration, a mixture of 0.5% ropivacaine 8 mL and dexamethasone 4 mg will be injected incrementally. Participants will be monitored for at least 30 minutes following the procedure

Repeated Pudendal Nerve Block + Standard Management

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• Refusal to participate.
• Previous episiotomy or perineal tear.
• Pain score ≤3/10.
• Known allergy to study medications.
• Pre-existing pudendal neuralgia.
• Pre-existing dyspareunia.

Sponsors & Collaborators

• Vinmec Healthcare System: lead

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Central Study Contacts

Philippe Macaire, MD

CONTACT

+840966103845; cm.apmc@vinmec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: data analyst blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms randomized controled pragmatic study

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: from end of analysis to 1 month after