Repeated Pudendal Nerve Block and Physiotherapy for Prevention of Chronic Post-Episiotomy Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorVinmec Healthcare System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Refusal to participate.
Previous episiotomy or perineal tear.
Pain score ≤3/10.
Known allergy to study medications.
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-Guided Pudendal Nerve Block
Procedure/SurgeryA 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
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Standard ManagementNo intervention 0 interventions
Group B: Repeated Pudendal Nerve Block + Standard ManagementExperimental treatment 1 intervention
Trial outcomes
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. (%)
Time frame
Post partum at end of week 8Secondary outcomes
1
pain intensity
Pain intensity assessed using the VAS ruler from 0 to 10 (0 = no pain- 10 = unbearable pain )
Time frame
Postpartum at Day 1, day 10, end of week 8 and end of month 3.2
Dyspareunia
Dyspareunia assessed using the Female Sexual Function Index. score from 2 to 36. Dyspareunia will be when the score is lower than 26,55 it will be evaluated at end of week 8 after the delivery and end of month 3 after delivery
Time frame
post partum end of week 8 and end of month 3 after delivery3
pudendal nerve block failure
Less than 50% pain relief at 30 minutes following the pudendal nerve block.
Time frame
30 minutes after pudendal block performance4
adverses events as Local anesthetic systemic toxicity, Hematoma, Infection or Rectal perforation
Percentage of patient presenting any complication as Local anesthetic systemic toxicity, Hematoma, Infection or Rectal perforation.
Time frame
Post partum from day of delivery though discharge up to 1 weekLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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