[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655331":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":49,"studyPopulation":37,"armGroups":50,"interventions":61,"overallOfficials":37,"centralContacts":67,"locations":37,"responsibleParty":73,"collaborators":37,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":37,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":101,"whyStopped":37,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":37},{"fullName":5,"class":6},"Vinmec Healthcare System","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"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).\n\nThis binary composite outcomes will be the incidence of patients with VAS \\> 3 or FSFI pain-domain score \\\u003C26,55 indicating dyspareunia - no\u002FTotal no. (%)","Post partum at end of week 8",[14,18,22,26,30,34],{"measure":15,"description":16,"timeFrame":17},"pain intensity","Pain intensity assessed using the VAS ruler from 0 to 10 (0 = no pain- 10 = unbearable pain )","Postpartum at Day 1, day 10, end of week 8 and end of month 3.",{"measure":19,"description":20,"timeFrame":21},"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","post partum end of week 8 and end of month 3 after delivery",{"measure":23,"description":24,"timeFrame":25},"pudendal nerve block failure","Less than 50% pain relief at 30 minutes following the pudendal nerve block.","30 minutes after pudendal block performance",{"measure":27,"description":28,"timeFrame":29},"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.","Post partum from day of delivery though discharge up to 1 week",{"measure":31,"description":32,"timeFrame":33},"Quality of recovery","The ObsQoR-10 (Obstetric Quality of Recovery-10) is a composite score ranging from 0 to 100, where a higher score reflects better postoperative recovery after cesarean delivery (or vaginal delivery, depending on the version validated) - 10 items scored and summed.","Post partum 24 hours after delivery and at day 10 after delivery",{"measure":35,"description":36,"timeFrame":17},"DN4 Score","Score to evaluate neuropathic phenotype of pain. Score from 0 to 10. when superior to 4 it means there is a neuropathic component of the pain",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","PARALLEL","2 arms randomized controled pragmatic study","PREVENTION",{"masking":44,"maskingDescription":45,"whoMasked":46},"DOUBLE","data analyst blinded",[47,48],"INVESTIGATOR","OUTCOMES_ASSESSOR","Context, rationale and hypothesis: Majority of pregnant women undergo vaginal delivery and although episiotomy is not recommended to be performed routinely, obstetric practices vary worldwide. At a maternity hospital in Vietnam, the reported episiotomy rate was 82.6% in primiparous and 22.8% in multiparous women. Depending on the degree of tissue trauma and other factors, the reported incidence of persistent post-episiotomy pain can range from 12% to 55% on the 2nd to 5th month. Dyspareunia is a complaint of persistent or recurrent pain or discomfort associated with attempted or completed vaginal penetration. Postpartum dyspareunia is common, with frequencies varying between 20% to 40% at six months and 13% to 60% in the first year. A study in Vietnam revealed 40.7% prevalence of sexual dysfunction (dyspareunia and lack of desire) on the 3rd month postpartum among women who had episiotomy. As such perineal trauma remains common following vaginal delivery and is associated with a high incidence of acute postpartum pain, which may progress to chronic pain and dyspareunia. Chronic post-surgical pain is strongly linked to inadequate early pain control, supporting the rationale for aggressive multimodal analgesia. The pudendal nerve plays a central role in perineal nociception. While single-shot pudendal nerve block has demonstrated efficacy in reducing acute post-episiotomy pain, its role in preventing chronic pain and dyspareunia remains unclear. Repeated pudendal nerve block combined with physiotherapy may reduce central sensitization and improve long-term outcomes.Originality and innovative aspects: The pudendal nerve block has been consistently demonstrated to be effective in the management of acute perineal pain, as supported by multiple randomized controlled trials. Its role in immediate postpartum analgesia is therefore well established. However, a substantial gap persists in the literature regarding its potential long-term benefits. Specifically, there is a near absence of studies evaluating the prevention of chronic post-episiotomy pain, despite the significant burden associated with this condition. Furthermore, data addressing postpartum dyspareunia remain extremely limited, leaving an important dimension of maternal health insufficiently explored. Pelvic floor physiotherapy is widely recommended as part of postpartum care. Nevertheless, it is rarely investigated in combination with regional anesthesia techniques in clinical trials, representing a missed opportunity to assess potential synergistic effects on both pain modulation and functional recovery. Additionally, repeated nerve block strategies have shown promise in the management of neuropathic pain in other clinical contexts. Yet, this approach has not been evaluated in obstetric populations, particularly in the postpartum setting. Taken together, the proposed study addresses critical unmet needs by exploring a novel, multimodal strategy that integrates repeated pudendal nerve blocks with pelvic floor rehabilitation. This approach is highly original and holds significant scientific relevance, with the potential to redefine preventive strategies for chronic postpartum perineal pain and associated sexual dysfunction.Main and secondary objectives: OutcomesPrimary Outcome: Composite outcome of pain intensity VAS \\> 3 or dyspareunia assessed using the Female Sexual Function Index \\\u003C 26,55 at week 8 Secondary Outcomes. Pain intensity assessed using the Visual analogue scale (VAS) ruler Day 10, week 8 and month 3 Level of dyspareunia assessed using the Female Sexual Function Index at: Week 8 and month 3.\n\nObstetric of recovery -10 (ObsQoR-10) ) at day of discharge, day 10. Douleur Neuropathique en 4 questions (DN4) Score at Day 10, week 8 and 3 months .\n\nIdentification of risk factors for chronic pain and dyspareunia Pudendal nerve block failure (defined as \\\u003C50% pain relief at 30 minutes) Adverse events incidence : Local anesthetic systemic toxicity, Hematoma, Infection or Rectal perforation Methods This study is a prospective, single-center, open-label, parallel-group randomized controlled trial with a 1:1 allocation ratio. The trial is designed in accordance with the consort consolidated standards of reporting trials 2010 Statement.\n\nSetting The study will be conducted at VinMec International Hospital, Times City, Hanoi, Vietnam.InterventionsControl Group (Standard Management): Participants will receive: Oral Paracetamol 500 mg every 6 hours; Oral Celecoxib 200 mg every 12 hours; Oral Nefopam as needed for pain \\>3\u002F10 and a Standardized physiotherapy program: Breathing exercises ; Pelvic floor exercises and a Perineal massage Intervention Group (Repeated Pudendal Nerve Block + Standard Management): Participants will receive standard management plus: A repeat pudendal nerve block prior to hospital discharge; The Block Technique: Dual guidance (ultrasound and nerve stimulator); Transperineal approach; Injection of 8 mL 0.5% Ropivacaine with 4 mg dexamethasone; Ipsilateral location.\n\nSample Size: Assuming a reduction in chronic pain incidence from 40% to 20%, with a two-sided alpha of 0.05 and 80% power, 94 participants (47 per group) are required. To account for a 10% dropout rate, a total of 104 participants will be enrolled. Analysis of the Population: Intention-to-treat (ITT) (primary analysis) and Per-protocol (sensitivity analysis) Descriptive Statistics: Continuous variables: mean ± SD or median (IQR) and Categorical variables: n (%) Comparison between groups using chi-square test or Fisher's exact test and Effect measures: Risk Ratio (RR) with 95% confidence interval and Absolute risk difference (B) Continuous composite score (secondary analysis): Standardization (z-scores) of BPI and FSFI pain domain scores; Aggregation into a single continuous composite score (e.g., mean of standardized values) Multiplicity and Hierarchy : The binary composite endpoint is the primary endpoint; Continuous composite and individual components are secondary\u002Fexploratory; Adjustment for multiple testing (e.g., Holm or Bonferroni) will be applied for secondary analyses Pain Scores longitudinal: Mixed-effects linear model; Fixed effects: group, time, group × time interaction Dyspareunia (binary outcome) : Chi-square test or Fisher's exact test; Relative risk (RR) with 95% CI Secondary Analyses : Logistic regression (Identify predictors of chronic pain\u002Fdyspareunia); Kaplan-Meier (optional): Time to pain resolution Handling Missing Data : Multiple imputation if \\>5% missing; Sensitivity analysis Significance Threshold : p \\\u003C 0.05 (two-sided) RandomizationSequence Generation: A computer-generated randomization list will be used.Allocation will be implemented using sequentially numbered, sealed, opaque envelopes.Implementation: Participants will be enrolled by investigators and assigned to groups according to the randomization sequence.Blinding: Due to the nature of the intervention, participants and treating clinicians cannot be blinded. However, outcome assessors and data analysts will be blinded to group allocation.Data Collection Methods: Pain and functional outcomes will be assessed at predefined time points using validated questionnaires: VAS ruler and Female Sexual Function Index. Data will be collected during follow-up visits or via structured interviews.",[51,55],{"label":52,"type":53,"description":54,"interventionNames":37},"Standard Management","NO_INTERVENTION","Participants will receive standard postpartum analgesic management consisting of:\n\nParacetamol 500 mg orally every 6 hours Celecoxib 200 mg orally every 12 hours Nefopam as needed for pain \\>3\u002F10 Standardized physiotherapy including breathing exercises, pelvic floor exercises and perineal massage",{"label":56,"type":57,"description":58,"interventionNames":59},"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.",[60],"Procedure: Ultrasound-Guided Pudendal Nerve Block",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":37},"PROCEDURE","Ultrasound-Guided Pudendal Nerve Block","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",[56],[68],{"name":69,"role":70,"phone":71,"phoneExt":37,"email":72},"Philippe Macaire, MD","CONTACT","+840966103845","cm.apmc@vinmec.com",{"type":74,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100655331","repeated-pudendal-nerve-block-and-physiotherapy-for-prevention-of-chronic-post-episiotomy-pain-100655331",false,"NCT07814183","Repeated Pudendal Nerve Block and Physiotherapy for Prevention of Chronic Post-Episiotomy Pain","Efficacy of Repeated Pudendal Nerve Block Combined With Physiotherapy for the Prevention of Chronic Post-Episiotomy Pain and Dyspareunia: A Randomized Controlled Trial","REPP","Inclusion Criteria:\n\nParticipants must meet all of the following:\n\n* Women aged 18-40 years.\n* Term pregnancy.\n* Vaginal delivery with episiotomy or first-time perineal tear.\n* Postpartum pain score \\>3\u002F10 within 24 hours after delivery.\n* Willingness to participate and provide informed consent. -\n\nExclusion Criteria:\n\n* Refusal to participate.\n* Previous episiotomy or perineal tear.\n* Pain score ≤3\u002F10.\n* Known allergy to study medications.\n* Pre-existing pudendal neuralgia.\n* Pre-existing dyspareunia.","FEMALE","18 Years","40 Years",{"count":87,"type":88},104,"ESTIMATED","INTERVENTIONAL",[91],"NA","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\u002F10 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\u002F10. Pain and sexual function will be assessed through 3 months postpartum.",[94,95],"Chronic Post-episiotomy Pain","Postpartum Dyspareunia",[97,98,99,100],"Episiotomy","analgesic pudendal nerve block","Chronic post episiotomy pain","post partum dyspareunia","NOT_YET_RECRUITING","2026-09-07",{"date":104,"type":105},"2026-09-10","ACTUAL",{"date":107,"type":88},"2026-09-01",{"date":109,"type":88},"2027-11-01",{"name":5,"class":6}]