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Recruiting NCT07401134

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

Phase IV Interventional Perineal Injury Pain Vulva Perineum; Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray.
Who it may be relevant to
Registry conditions: Perineal Injury, Pain Vulva, Perineum; Injury. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Perineal 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.

Primary outcome measures

  • Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups [Time frame: 3 Days]
Secondary outcome measures (4)
  • Difference in Daily Pain Scores Within Post-Operative Days 0-7 Between Control and MPAP Groups [Time frame: 7 Days]
  • Difference in Total Number of Doses of Each Class of Analgesic Medications Within Post-Operative Days 0-7 Between Control and Interventional Groups [Time frame: 7 Days]
  • Difference in Patient Satisfaction Scores at 2 Weeks Post-Operation Between Control and Interventional Groups [Time frame: 2 Weeks]
  • Incidence of Adverse Events Experienced by Participants Within Post-Operative Days 0-7 Between Control and Interventional Groups [Time frame: 7 Days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami Hospitals and Clinics — Miami

Identifiers

NCT: NCT07401134 · 20251232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗