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NCT07401134PHASE4Recruiting

Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery

University of Miami

Start Date

2/18/2026

Completion Date

2/1/2027

Summary

The purpose of this research is to determine if using perineal ice packs, medicated witch-hazel pads (MAJOR® Medi-Pads), and topical benzocaine spray (Dermoplast®) helps reduce perineal pain after perineorrhaphy and/or posterior colporrhaphy surgery.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray

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Conditions

Perineal InjuryPain VulvaPerineum; Injury

Locations

University of Miami Hospitals and Clinics

Miami, Florida 33136

United States