Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After … (NCT07401134) | Clinical Trial Compass
RecruitingPhase 4
Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
United States70 participantsStarted 2026-02-18
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
Difference in Perineal Pain Score on Postoperative Day (POD) 3 Between Control and Interventional Groups