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
Conditions
Perineal InjuryPain VulvaPerineum; Injury
Locations
University of Miami Hospitals and Clinics
Miami, Florida 33136
United States