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

{ "Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery", "This study is looking at whether a special pain relief protocol helps women recover after vaginal surgery like perineorrhaphy or posterior colporrhaphy (rectocele repair/posterior repair). The protocol involves using perineal ice packs, medicated witch-hazel pads (MAJOR® Medi-Pads), and topical benzocaine spray (Dermoplast®). You might be able to join if you are a woman aged 18 or older having one of these surgeries and can apply the pain relief products yourself. The main goal is to see if this protocol reduces perineal (area between vagina and anus) pain three days after surgery. This study plans to include 70 participants, but its current recruitment status is unclear.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 70 women.", "commitments": "Participants will follow the Multimodal Perineal Analgesic Protocol (MPAP) in addition to their normal post-operation care. You will receive a kit with 14 perineal ice packs and medicated witch-hazel pads to use at home.", "compensation": "Not stated in the trial record.", "follow_up": "Your perineal pain score will be measured three days after surgery.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07401134

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

Recruiting
PHASE4Ages 18+InterventionalSupportive care
University of Miami
~70 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups
Measured over 3 Days
Perineal Injury
Pain Vulva
Perineum; Injury

NCT07401134

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Miami Hospitals and Clinics

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Katherine Amin, MD · PRINCIPAL_INVESTIGATOR · University of Miami

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Eligibility criteria

Inclusion

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

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
  • Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups3 Days

    Perineal Pain Score will be assessed using a 10-cm Visual Analog Scale (VAS). It consists of a 10 cm line with "no pain" at one end (0) and "worst possible pain" at the other (10). Participants will mark the line to indicate their level of pain or sensation. A higher score indicates a more severe level of pain.