Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
Recruiting now · Phase 4
Conditions studied: Perineal Injury, Pain Vulva, Perineum; Injury
In brief
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.
Key facts
- Study ID
- NCT07401134
- Run by
- University of Miami
- People needed
- 70
- Starts
- 2026-02-18
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Miami Hospitals and Clinics — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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