RecruitingPhase 4NCT07401134

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

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


Sponsor

University of Miami

Enrollment

70 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

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

Participants will follow the Multimodal Perineal Analgesic Protocol (MPAP) in addition to their normal post-operation care. Participants will receive a Perineal Care Kit prior to discharge from the hospital. This kit will contain 14 perineal ice packs, one container of 100 medicated witch-hazel pads (MAJOR® Medi-Pads), and one 2.75 oz can of 20% benzocaine with aloe spray (Dermoplast®). Participants will receive written instructions for use of these products.


Locations(1)

University of Miami Hospitals and Clinics

Miami, Florida, United States

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NCT07401134


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