Multimodal perineal analgesia protocol after vaginal repair
Official title: Improving Postoperative Recovery: A Randomized Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
Run by University of Miami · NCT07401134 · Data updated 2026-11-12
This will try ice packs, medicated witch-hazel pads, and a topical benzocaine spray to reduce perineal pain after perineorrhaphy or posterior colporrhaphy in adult women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | February 18, 2026 |
| Main results expected | January 2027 |
| Study ends | February 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07401134 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (≥18 years) undergoing perineorrhaphy and/or posterior colporrhaphy as part of planned vaginal pelvic reconstructive surgery who can apply the medicated pads and spray and provide informed consent are ideal candidates.
✕Probably not a fit
Patients with known allergy to witch-hazel, benzocaine, aloe or other product ingredients, those with chronic pelvic pain conditions, prolonged indwelling catheters, or chronic opioid use are unlikely to receive benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult women undergoing perineorrhaphy and/or posterior colporrhaphy as part of vaginal pelvic reconstructive surgery will follow a multimodal perineal analgesia protocol using perineal ice packs, medicated witch-hazel pads (MAJOR Medi-Pads), and topical benzocaine spray (Dermoplast) applied after surgery. Participants will self-administer the products according to the postoperative instructions provided by the study team. Pain scores, analgesic use, and postoperative recovery metrics will be collected during the early postoperative period to characterize pain trajectories and recovery. Key exclusions that could confound pain measurement include allergies to product ingredients, chronic pelvic pain syndromes, prolonged indwelling catheters, and chronic opioid use.
Why it matters
Potential benefit: If successful, this protocol could reduce postoperative perineal pain and lower the need for stronger systemic analgesics after vaginal repair procedures.
How similar studies have gone: Topical cooling, witch-hazel preparations, and local anesthetic sprays have clinical use and some supportive reports for perineal or postpartum discomfort, but rigorous data specifically testing a combined multimodal protocol after perineal repair are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women ≥ 18 years of age * Undergoing perineorrhaphy and/or posterior colporrhaphy (rectocele repair/posterior repair) as part of their planned vaginal pelvic reconstructive surgery * Physically able to apply medicated witch-hazel pads (MAJOR® Medi-Pads) and administer topical benzocaine spray (Dermoplast®) to the perineal area * Able to understand and willing to provide informed consent Exclusion Criteria: * Known allergy or hypersensitivity to any of the study products or components, including witch hazel, benzocaine, aloe, or other product ingredients * Minors * Presence of an indwelling catheter expected to remain in place for ≥7 days postoperatively * History of chronic pelvic pain syndromes that may confound postoperative pain assessment, including interstitial cystitis/bladder pain syndrome (IC/BPS), endometriosis, pudendal neuralgia, or vulvodynia * Chronic use (\> 3 weeks of continuous use) of opioid pain medication * Presence of vulvar dermatoses such as lichen sclerosus, lichen planus, or lichen simplex chronicus * Currently pregnant or breastfeeding * Anticipated inability to complete postoperative follow-up, including physical or cognitive limitations that would impede self-care or completion of study diaries * Inability or unwillingness to provide informed consent or comply with study procedures
Where it's running
-
University of Miami Hospitals and Clinics
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Katherine Amin, MD — University of Miami
- Study coordinator: Katherine Amin, MD
- Email: katherine.amin@med.miami.edu
- Phone: (305) 243-6590
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Physiotherapy and cold‑pack treatment for first-time mothers with perineal tears after vaginal delivery
This will test whether pelvic floor muscle exercises plus cryotherapy started right after birth reduce perineal pain for first-time mothers who had a grade 2 or higher tear or an episiotomy.
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Using Epsom salt compresses to relieve postpartum perineal pain
This study is testing if Epsom salt compresses can help women feel less pain in their perineal area after giving birth.
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Robot-assisted reconstruction after surgery for rectal or anal cancer
This study is testing if using a muscle flap to rebuild the pelvic floor or vagina after robotic surgery for rectal or anal cancer can improve recovery and quality of life for patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.