Multimodal perineal analgesia protocol after vaginal repair
Improving Postoperative Recovery: A Randomized Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
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 |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07401134 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.